0 Ratings
ID

45906

Description

Principal Investigator: Soonmyung Paik, National Surgical Adjuvant Breast and Bowel Project, Pittsburgh PA, USA MeSH: Breast Neoplasms https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000826 **Background** National Surgical Adjuvant Breast and Bowel Project (NSABP) trial B-31 suggested the efficacy of adjuvant trastuzumab, even in HER2-negative breast cancer. This finding prompted us to develop a predictive model for degree of benefit from trastuzumab using archived tumor blocks from B-31. **Methods** Case subjects with tumor blocks were randomly divided into discovery (n = 588) and confirmation cohorts (n = 991). A predictive model was built from the discovery cohort through gene expression profiling of 462 genes with nCounter assay. A predefined cut point for the predictive model was tested in the confirmation cohort. Gene-by-treatment interaction was tested with Cox models, and correlations between variables were assessed with Spearman correlation. Principal component analysis was performed on the final set of selected genes. All statistical tests were two-sided. **Results** Eight predictive genes associated with HER2 (ERBB2, c17orf37, GRB7) or ER (ESR1, NAT1, GATA3, CA12, IGF1R) were selected for model building. Three-dimensional subset treatment effect pattern plot using two principal components of these genes was used to identify a subset with no benefit from trastuzumab, characterized by intermediate-level ERBB2 and high-level ESR1 mRNA expression. In the confirmation set, the predefined cut points for this model classified patients into three subsets with differential benefit from trastuzumab with hazard ratios of 1.58 (95% confidence interval [CI] = 0.67 to 3.69; P = .29; n = 100), 0.60 (95% CI = 0.41 to 0.89; P = .01; n = 449), and 0.28 (95% CI = 0.20 to 0.41; P .001; n = 442; P interaction between the model and trastuzumab .001). **Conclusions** We developed a gene expression-based predictive model for degree of benefit from trastuzumab and demostrated that HER2-negative tumors belong to the moderate benefit group, thus providing justification for testing trastuzumab in HER2-negative patients (NSABP B-47). ** Reprinted from J Natl Cancer Inst;2013;105:1782-1788 with permission from Oxford University Press.

Link

dbGaP study = phs000826

Keywords

Versions (1)
  1. 1/16/24 1/16/24 - Simon Heim
Copyright Holder

Soonmyung Paik, National Surgical Adjuvant Breast and Bowel Project, Pittsburgh PA, USA

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January 16, 2024

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Creative Commons BY 4.0
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    dbGaP phs000826 Prediction of Trastuzumab Benefit in Adjuvant Breast Cancer: NSABP B31

    English

    Eligibility Criteria

    5 forms  
    Inclusion and exclusion criteria
    Description

    Inclusion and exclusion criteria

    Alias
    UMLS CUI [1,1]
    C1512693
    UMLS CUI [1,2]
    C0680251
    **Conditions for Eligibility to the Gene Expression Study**
    Description

    **Conditions for Eligibility to the Gene Expression Study**

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1516637
    Consented to future cancer research
    Description

    Consented to future cancer research

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C5446093
    UMLS CUI [1,2]
    C0016884
    Available tumor block
    Description

    Available tumor block

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0470187
    UMLS CUI [1,2]
    C3273930
    Known ER status
    Description

    Known ER status

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2919271
    Known number of positive nodes
    Description

    Known number of positive nodes

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C4086646
    *PATIENT ELIGIBILITY AND INELIGIBILITY* *Conditions for patient eligibility* Female patients who satisfy all of the following conditions are the only patients who will be eligible for this study:
    Description

    *PATIENT ELIGIBILITY AND INELIGIBILITY* *Conditions for patient eligibility* Female patients who satisfy all of the following conditions are the only patients who will be eligible for this study:Elig.phs000826.v1.p1.6

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013893
    UMLS CUI [1,2]
    C0043210
    The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines.
    Description

    The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0742766
    UMLS CUI [1,3]
    C0009797
    UMLS CUI [1,4]
    C0750484
    UMLS CUI [1,5]
    C0162791
    The patient must have a life expectancy of at least 10 years, excluding her diagnosis of breast cancer. (Comorbid conditions should be taken into consideration, but not the diagnosis of breast cancer.)
    Description

    The patient must have a life expectancy of at least 10 years, excluding her diagnosis of breast cancer. (Comorbid conditions should be taken into consideration, but not the diagnosis of breast cancer.)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0023671
    UMLS CUI [1,2]
    C0332168
    UMLS CUI [1,3]
    C2828389
    UMLS CUI [1,4]
    C0011900
    UMLS CUI [1,5]
    C0006142
    UMLS CUI [2,1]
    C1275743
    UMLS CUI [2,2]
    C0518609
    The interval between the last surgery for breast cancer treatment (lumpectomy, mastectomy, axillary dissection, or re-excision of lumpectomy margins) and randomization must be less than or equal to 84 days.
    Description

    The interval between the last surgery for breast cancer treatment (lumpectomy, mastectomy, axillary dissection, or re-excision of lumpectomy margins) and randomization must be less than or equal to 84 days.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0332168
    UMLS CUI [1,2]
    C1517741
    UMLS CUI [1,3]
    C0543467
    UMLS CUI [1,4]
    C1511300
    UMLS CUI [1,5]
    C0851238
    UMLS CUI [1,6]
    C0024881
    UMLS CUI [1,7]
    C0193867
    UMLS CUI [1,8]
    C0184913
    UMLS CUI [1,9]
    C0034656
    All of the following staging criteria must be met: - Primary tumor must be T1-3 by *clinical* and *pathologic* evaluation. - Ipsilateral nodes must be cN0-1 by *clinical* evaluation. - Ipsilateral nodes must be pN1, pN2a, or pN3a by *pathologic* evaluation. - M0
    Description

    All of the following staging criteria must be met: - Primary tumor must be T1-3 by *clinical* and *pathologic* evaluation. - Ipsilateral nodes must be cN0-1 by *clinical* evaluation. - Ipsilateral nodes must be pN1, pN2a, or pN3a by *pathologic* evaluation. - M0

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0027646
    UMLS CUI [1,2]
    C5444992
    UMLS CUI [1,3]
    C0677930
    UMLS CUI [1,4]
    C1270004
    UMLS CUI [1,5]
    C1275863
    UMLS CUI [2,1]
    C5761362
    UMLS CUI [2,2]
    C0441962
    UMLS CUI [2,3]
    C4084924
    UMLS CUI [2,4]
    C0030664
    Patients must have undergone either a total mastectomy and an axillary dissection or a lumpectomy and an axillary dissection. Sentinel node biopsy is permitted, but must be followed by an axillary dissection.
    Description

    Patients must have undergone either a total mastectomy and an axillary dissection or a lumpectomy and an axillary dissection. Sentinel node biopsy is permitted, but must be followed by an axillary dissection.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2960728
    UMLS CUI [1,2]
    C0851238
    UMLS CUI [1,3]
    C0193867
    UMLS CUI [1,4]
    C0796693
    The tumor must be invasive adenocarcinoma on histologic examination.
    Description

    The tumor must be invasive adenocarcinoma on histologic examination.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0858252
    UMLS CUI [1,2]
    C0205281
    UMLS CUI [1,3]
    C0205462
    UMLS CUI [1,4]
    C4321457
    The tumor must be determined to be HER2-positive prior to randomization. Assays performed using fluorescent in situ hybridization (FISH) require gene amplification to be eligible. Assays using immunohistochemistry (IHC) must be performed at an NSABP-approved reference laboratory and require a strongly positive staining score (See Section 9.0).
    Description

    The tumor must be determined to be HER2-positive prior to randomization. Assays performed using fluorescent in situ hybridization (FISH) require gene amplification to be eligible. Assays using immunohistochemistry (IHC) must be performed at an NSABP-approved reference laboratory and require a strongly positive staining score (See Section 9.0).

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1960398
    UMLS CUI [1,2]
    C5421123
    UMLS CUI [1,3]
    C0162789
    UMLS CUI [1,4]
    C0017256
    UMLS CUI [1,5]
    C0013893
    UMLS CUI [2,1]
    C0021044
    UMLS CUI [2,2]
    C1513905
    UMLS CUI [2,3]
    C1532342
    UMLS CUI [2,4]
    C5784376
    UMLS CUI [2,5]
    C1704680
    Patients must have an analysis of both estrogen and progesterone receptors performed on the primary tumor prior to randomization (see Section 10.0). "Marginal," "borderline," etc., results (i.e., those not definitely negative) will also be considered positive regardless of the methodology used.
    Description

    Patients must have an analysis of both estrogen and progesterone receptors performed on the primary tumor prior to randomization (see Section 10.0). "Marginal," "borderline," etc., results (i.e., those not definitely negative) will also be considered positive regardless of the methodology used.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1440607
    UMLS CUI [1,2]
    C0936012
    UMLS CUI [1,3]
    C0677930
    UMLS CUI [1,4]
    C5421123
    UMLS CUI [2,1]
    C0205284
    UMLS CUI [2,2]
    C0205189
    UMLS CUI [2,3]
    C0750591
    UMLS CUI [2,4]
    C1446409
    UMLS CUI [2,5]
    C3641650
    UMLS CUI [2,6]
    C3266812
    At the time of randomization, the patient must have had the following: history and physical exam, EKG, and PA and lateral chest x-ray within the past 3 months; and a bilateral mammogram (or unilateral if patient has had a mastectomy) and a pelvic exam (for women who have a uterus and who will be taking tamoxifen) within the past year.
    Description

    At the time of randomization, the patient must have had the following: history and physical exam, EKG, and PA and lateral chest x-ray within the past 3 months; and a bilateral mammogram (or unilateral if patient has had a mastectomy) and a pelvic exam (for women who have a uterus and who will be taking tamoxifen) within the past year.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0034656
    UMLS CUI [1,2]
    C1442880
    UMLS CUI [1,3]
    C0262926
    UMLS CUI [1,4]
    C0031809
    UMLS CUI [1,5]
    C1623258
    UMLS CUI [1,6]
    C5159055
    UMLS CUI [1,7]
    C4086725
    UMLS CUI [1,8]
    C2236946
    UMLS CUI [1,9]
    C0200045
    UMLS CUI [1,10]
    C3887293
    Within 3 months prior to entry, the patient must have a baseline LVEF measured by MUGA scan equal to or greater than the lower limit of normal for the radiology facility. (If LVEF is > 75%, the investigator should consider having the LVEF determination reviewed prior to randomization. Following randomization, the LVEF determination may be reviewed up until the time of the post-AC MUGA.
    Description

    Within 3 months prior to entry, the patient must have a baseline LVEF measured by MUGA scan equal to or greater than the lower limit of normal for the radiology facility. (If LVEF is > 75%, the investigator should consider having the LVEF determination reviewed prior to randomization. Following randomization, the LVEF determination may be reviewed up until the time of the post-AC MUGA.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C4086725
    UMLS CUI [1,2]
    C1442488
    UMLS CUI [1,3]
    C3837267
    UMLS CUI [1,4]
    C0521317
    UMLS CUI [1,5]
    C0439091
    UMLS CUI [1,6]
    C1518030
    UMLS CUI [1,7]
    C3844340
    UMLS CUI [2,1]
    C3837267
    UMLS CUI [2,2]
    C1709940
    UMLS CUI [2,3]
    C0034656
    UMLS CUI [2,4]
    C0521317
    At the time of randomization: - The postoperative absolute neutrophil count (ANC) must be ≥ 1500/mm3 (or <1500/mm3 if, in the opinion of the investigator, this represents an ethnic or racial variation of normal). - Postoperative platelet count must be ≥ 100,000/mm3. Significant underlying hematologic disorders must be excluded when the platelet count is above the upper limit of normal for the lab. - There must be postoperative evidence of adequate hepatic function, i.e., a. total bilirubin must be ≤ ULN for the lab unless the patient has a chronic grade 1 bilirubin elevation (>ULN to ≤1.5 x ULN) due to Gilbert's disease or similar syndrome; and b. alkaline phosphatase must be <2.5 times the ULN for the lab; and the SGOT [AST] must be <1.5 times the ULN for the lab. - There must be postoperative evidence of adequate renal function (serum creatinine within or less than the institution's normal range).
    Description

    At the time of randomization: - The postoperative absolute neutrophil count (ANC) must be ≥ 1500/mm3 (or <1500/mm3 if, in the opinion of the investigator, this represents an ethnic or racial variation of normal). - Postoperative platelet count must be ≥ 100,000/mm3. Significant underlying hematologic disorders must be excluded when the platelet count is above the upper limit of normal for the lab. - There must be postoperative evidence of adequate hepatic function, i.e., a. total bilirubin must be ≤ ULN for the lab unless the patient has a chronic grade 1 bilirubin elevation (>ULN to ≤1.5 x ULN) due to Gilbert's disease or similar syndrome; and b. alkaline phosphatase must be <2.5 times the ULN for the lab; and the SGOT [AST] must be <1.5 times the ULN for the lab. - There must be postoperative evidence of adequate renal function (serum creatinine within or less than the institution's normal range).

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1442880
    UMLS CUI [1,2]
    C0034656
    UMLS CUI [1,3]
    C0032790
    UMLS CUI [1,4]
    C1699112
    UMLS CUI [1,5]
    C1521895
    UMLS CUI [1,6]
    C0600219
    UMLS CUI [2,1]
    C0032790
    UMLS CUI [2,2]
    C0836924
    UMLS CUI [2,3]
    C1546944
    UMLS CUI [2,4]
    C0018939
    UMLS CUI [2,5]
    C1277606
    UMLS CUI [3,1]
    C0032790
    UMLS CUI [3,2]
    C5554846
    UMLS CUI [3,3]
    C0205411
    UMLS CUI [3,4]
    C0232741
    UMLS CUI [3,5]
    C0201913
    UMLS CUI [3,6]
    C0002059
    UMLS CUI [3,7]
    C0004002
    UMLS CUI [3,8]
    C3163633
    UMLS CUI [3,9]
    C1519815
    UMLS CUI [3,10]
    C4685048
    UMLS CUI [3,11]
    C0017551
    UMLS CUI [4,1]
    C0032790
    UMLS CUI [4,2]
    C5554846
    UMLS CUI [4,3]
    C0232804
    UMLS CUI [4,4]
    C0600061
    UMLS CUI [4,5]
    C0086715
    Patients must have no clinical or radiologic evidence of metastatic disease. Suspicious findings must be confirmed as benign by radiologic evaluation or biopsy. A patient with skeletal pain is eligible for inclusion in the study if bone scan and/or roentgenological examination fails to disclose metastatic disease.
    Description

    Patients must have no clinical or radiologic evidence of metastatic disease. Suspicious findings must be confirmed as benign by radiologic evaluation or biopsy. A patient with skeletal pain is eligible for inclusion in the study if bone scan and/or roentgenological examination fails to disclose metastatic disease.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1711337
    UMLS CUI [1,2]
    C2939420
    UMLS CUI [1,3]
    C0005558
    UMLS CUI [1,4]
    C0750484
    UMLS CUI [1,5]
    C0086692
    UMLS CUI [2,1]
    C0151825
    UMLS CUI [2,2]
    C0680253
    UMLS CUI [2,3]
    C0855682
    UMLS CUI [2,4]
    C0043299
    UMLS CUI [2,5]
    C5785236
    UMLS CUI [2,6]
    C2939420
    Patients with a history of *non-breast* malignancies are eligible if they have been disease-free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
    Description

    Patients with a history of *non-breast* malignancies are eligible if they have been disease-free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0006826
    UMLS CUI [1,3]
    C1518422
    UMLS CUI [1,4]
    C0006141
    UMLS CUI [1,5]
    C1548635
    UMLS CUI [1,6]
    C5401422
    UMLS CUI [1,7]
    C3843495
    UMLS CUI [1,8]
    C0332152
    UMLS CUI [1,9]
    C0034656
    UMLS CUI [1,10]
    C0600219
    UMLS CUI [1,11]
    C2986492
    UMLS CUI [1,12]
    C0205251
    UMLS CUI [2,1]
    C1548635
    UMLS CUI [2,2]
    C0006826
    UMLS CUI [2,3]
    C0011900
    UMLS CUI [2,4]
    C0087111
    UMLS CUI [2,5]
    C0332168
    UMLS CUI [2,6]
    C0851140
    UMLS CUI [2,7]
    C0346040
    UMLS CUI [2,8]
    C4721806
    UMLS CUI [2,9]
    C0007137
    Prior to randomization, the investigator must designate whether the patients who had a lumpectomy will receive local or locoregional radiation therapy. For patients who had a mastectomy, the investigator must designate whether or not the patient will receive radiation therapy. (Pre-randomization discussion and/or consultation with a radiation oncologist is encouraged.) Note: *Irradiation of any internal mammary nodes is prohibited in this trial.* *Special conditions for eligibility of lumpectomy patients: irradiation and surgery* Patients treated by lumpectomy and axillary node dissection to be followed by breast radiation therapy must meet all the eligibility criteria in above in addition to the following:
    Description

    Prior to randomization, the investigator must designate whether the patients who had a lumpectomy will receive local or locoregional radiation therapy. For patients who had a mastectomy, the investigator must designate whether or not the patient will receive radiation therapy. (Pre-randomization discussion and/or consultation with a radiation oncologist is encouraged.) Note: *Irradiation of any internal mammary nodes is prohibited in this trial.* *Special conditions for eligibility of lumpectomy patients: irradiation and surgery* Patients treated by lumpectomy and axillary node dissection to be followed by breast radiation therapy must meet all the eligibility criteria in above in addition to the following:

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0332152
    UMLS CUI [1,2]
    C0034656
    UMLS CUI [1,3]
    C1521895
    UMLS CUI [1,4]
    C5420090
    UMLS CUI [1,5]
    C0262926
    UMLS CUI [1,6]
    C0851238
    UMLS CUI [1,7]
    C1522449
    UMLS CUI [1,8]
    C1517925
    UMLS CUI [1,9]
    C3846158
    UMLS CUI [2,1]
    C1521895
    UMLS CUI [2,2]
    C5420090
    UMLS CUI [2,3]
    C0262926
    UMLS CUI [2,4]
    C0024881
    UMLS CUI [2,5]
    C1522449
    UMLS CUI [3,1]
    C0683610
    UMLS CUI [3,2]
    C1522449
    UMLS CUI [3,3]
    C0447180
    UMLS CUI [3,4]
    C2599718
    UMLS CUI [4,1]
    C1516637
    UMLS CUI [4,2]
    C5236034
    UMLS CUI [4,3]
    C1522449
    UMLS CUI [4,4]
    C0543467
    UMLS CUI [5,1]
    C0851238
    UMLS CUI [5,2]
    C0193867
    UMLS CUI [5,3]
    C0332283
    UMLS CUI [5,4]
    C1522449
    UMLS CUI [5,5]
    C0006141
    UMLS CUI [5,6]
    C1516637
    Generally, lumpectomy should be reserved for tumors <5 cm. However, at the investigator's discretion, patients treated with lumpectomy for tumors ≥ 5 cm are eligible.
    Description

    Generally, lumpectomy should be reserved for tumors <5 cm. However, at the investigator's discretion, patients treated with lumpectomy for tumors ≥ 5 cm are eligible.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0851238
    UMLS CUI [1,2]
    C5769400
    UMLS CUI [1,3]
    C5441575
    UMLS CUI [1,4]
    C1521895
    UMLS CUI [1,5]
    C5556474
    The margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist. In patients in whom pathologic examination demonstrates tumor present at the line of resection, additional operative procedures may be performed to obtain clear margins. This is permissible even if axillary dissection has been performed. Patients in whom tumor is still present at the resected margin after re-excision(s) must undergo total mastectomy to be eligible.
    Description

    The margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist. In patients in whom pathologic examination demonstrates tumor present at the line of resection, additional operative procedures may be performed to obtain clear margins. This is permissible even if axillary dissection has been performed. Patients in whom tumor is still present at the resected margin after re-excision(s) must undergo total mastectomy to be eligible.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1709157
    UMLS CUI [1,2]
    C0007124
    UMLS CUI [1,3]
    C0332142
    Whole breast irradiation is required. Irradiation of regional lymph nodes is optional, *but partial breast irradiation and irradiation of any internal mammary nodes are prohibited in this trial.* Intent to irradiate the axilla or other regional node groups must be declared by the investigator prior to randomization for stratification purposes. Please see guidelines for radiotherapy in Appendix A. *Special conditions for eligibility of mastectomy patients: irradiation* The decision to use locoregional irradiation in patients who have undergone total mastectomy and axillary node dissection must be declared by the investigator prior to randomization for stratification purposes. Failure to adhere to the radiation therapy plan will be a protocol violation. Also note that *irradiation of any internal mammary nodes is prohibited in this trial.*
    Description

    Whole breast irradiation is required. Irradiation of regional lymph nodes is optional, *but partial breast irradiation and irradiation of any internal mammary nodes are prohibited in this trial.* Intent to irradiate the axilla or other regional node groups must be declared by the investigator prior to randomization for stratification purposes. Please see guidelines for radiotherapy in Appendix A. *Special conditions for eligibility of mastectomy patients: irradiation* The decision to use locoregional irradiation in patients who have undergone total mastectomy and axillary node dissection must be declared by the investigator prior to randomization for stratification purposes. Failure to adhere to the radiation therapy plan will be a protocol violation. Also note that *irradiation of any internal mammary nodes is prohibited in this trial.*

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3897169
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C4759292
    UMLS CUI [1,4]
    C1518600
    UMLS CUI [1,5]
    C3897989
    UMLS CUI [1,6]
    C0447180
    UMLS CUI [1,7]
    C1522449
    UMLS CUI [1,8]
    C0683610
    UMLS CUI [1,9]
    C2599718
    UMLS CUI [2,1]
    C1292734
    UMLS CUI [2,2]
    C1522449
    UMLS CUI [2,3]
    C0004454
    UMLS CUI [2,4]
    C1179441
    *Conditions for patient ineligibility* Male patients are not eligible for this study. Patients with one or more of the following conditions or prior therapies are also ineligible for this study:
    Description

    *Conditions for patient ineligibility* Male patients are not eligible for this study. Patients with one or more of the following conditions or prior therapies are also ineligible for this study:

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1512714
    UMLS CUI [1,2]
    C0348080
    UMLS CUI [1,3]
    C0086582
    UMLS CUI [1,4]
    C0332132
    UMLS CUI [1,5]
    C1514463
    UMLS CUI [1,6]
    C1265611
    Bilateral malignancy or a mass or mammographic abnormality in the opposite breast suspicious for malignancy unless there is biopsy proof that the mass is not malignant.
    Description

    Bilateral malignancy or a mass or mammographic abnormality in the opposite breast suspicious for malignancy unless there is biopsy proof that the mass is not malignant.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0238767
    UMLS CUI [1,2]
    C0006826
    UMLS CUI [1,3]
    C0024103
    UMLS CUI [1,4]
    C0441988
    UMLS CUI [1,5]
    C0262365
    UMLS CUI [1,6]
    C4050405
    UMLS CUI [1,7]
    C0332300
    UMLS CUI [1,8]
    C1334932
    UMLS CUI [1,9]
    C0405352
    Primary tumor staged as T4 for any reason
    Description

    Primary tumor staged as T4 for any reason

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0677930
    UMLS CUI [1,2]
    C0475751
    Nodes staged as *clinical* N2 or N3 for any reason and nodes staged as *pathologic* pN2b, pN3b, or pN3c.
    Description

    Nodes staged as *clinical* N2 or N3 for any reason and nodes staged as *pathologic* pN2b, pN3b, or pN3c.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C5702804
    UMLS CUI [1,2]
    C5702667
    UMLS CUI [1,3]
    C1711122
    UMLS CUI [1,4]
    C1711125
    UMLS CUI [1,5]
    C1711126
    Prior history of breast cancer, including DCIS (patients with a history of LCIS are eligible).
    Description

    aPrior history of breast cancer, including DCIS (patients with a history of LCIS are eligible).

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0006142
    UMLS CUI [1,3]
    C0007124
    UMLS CUI [2,1]
    C0262926
    UMLS CUI [2,2]
    C0279563
    UMLS CUI [2,3]
    C1548635
    Treatment including radiation therapy, chemotherapy, biotherapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to randomization. The only exception is hormonal therapy, which may have been given for up to a total of 28 days anytime after diagnosis and before randomization. In such a case, hormonal therapy must stop at or before randomization and be re-started if indicated following chemotherapy.
    Description

    Treatment including radiation therapy, chemotherapy, biotherapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to randomization. The only exception is hormonal therapy, which may have been given for up to a total of 28 days anytime after diagnosis and before randomization. In such a case, hormonal therapy must stop at or before randomization and be re-started if indicated following chemotherapy.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C1522449
    UMLS CUI [1,3]
    C3665472
    UMLS CUI [1,4]
    C0005527
    UMLS CUI [1,5]
    C0279025
    UMLS CUI [1,6]
    C5421123
    UMLS CUI [1,7]
    C0521116
    UMLS CUI [1,8]
    C0920688
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0279025
    UMLS CUI [2,3]
    C0332168
    UMLS CUI [2,4]
    C0231290
    UMLS CUI [2,5]
    C0920688
    UMLS CUI [2,6]
    C1947925
    UMLS CUI [2,7]
    C5421123
    UMLS CUI [3,1]
    C0580673
    UMLS CUI [3,2]
    C3146298
    UMLS CUI [3,3]
    C0332282
    UMLS CUI [3,4]
    C3665472
    Prior anthracycline or taxane therapy for any malignancy.
    Description

    Prior anthracycline or taxane therapy for any malignancy.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0278941
    UMLS CUI [1,2]
    C1514463
    UMLS CUI [1,3]
    C0796419
    UMLS CUI [1,4]
    C0006826
    Any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. (These patients are eligible only if this therapy is discontinued prior to randomization.)
    Description

    Any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. (These patients are eligible only if this therapy is discontinued prior to randomization.)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C0279025
    UMLS CUI [1,3]
    C0036884
    UMLS CUI [1,4]
    C0240604
    UMLS CUI [1,5]
    C0282402
    UMLS CUI [2,1]
    C1548635
    UMLS CUI [2,2]
    C1555300
    UMLS CUI [2,3]
    C5421123
    Therapy with any hormonal agents such as raloxifene (Evista®), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or prevention. (Patients are eligible only if these medications are discontinued prior to randomization. These medications are not permitted while on the study except for the use of tamoxifen.)
    Description

    Therapy with any hormonal agents such as raloxifene (Evista®), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or prevention. (Patients are eligible only if these medications are discontinued prior to randomization. These medications are not permitted while on the study except for the use of tamoxifen.)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0279025
    UMLS CUI [1,2]
    C0244404
    UMLS CUI [1,3]
    C0039286
    UMLS CUI [1,4]
    C0732611
    UMLS CUI [1,5]
    C2114408
    UMLS CUI [1,6]
    C3650929
    UMLS CUI [2,1]
    C1548635
    UMLS CUI [2,2]
    C1444662
    UMLS CUI [2,3]
    C5421123
    UMLS CUI [3,1]
    C3242263
    UMLS CUI [3,2]
    C0947630
    UMLS CUI [3,3]
    C0332300
    UMLS CUI [3,4]
    C1524063
    UMLS CUI [3,5]
    C0039286
    Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude a patient from being subjected to any of the treatment options or would prevent prolonged follow-up.
    Description

    Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude a patient from being subjected to any of the treatment options or would prevent prolonged follow-up.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C5669530
    UMLS CUI [1,2]
    C0007222
    UMLS CUI [1,3]
    C0022658
    UMLS CUI [1,4]
    C0023895
    UMLS CUI [1,5]
    C2828389
    UMLS CUI [1,6]
    C0683525
    UMLS CUI [1,7]
    C0439590
    UMLS CUI [1,8]
    C0589120
    Cardiac disease that would preclude the use of Adriamycin, Taxol or Herceptin. This includes: *Active cardiac disease:* - angina pectoris that requires the use of antianginal medication; - cardiac arrhythmia requiring medication; - severe conduction abnormality; - clinically significant valvular disease; - cardiomegaly on chest x-ray; - ventricular hypertrophy on EKG; or - patients with poorly controlled hypertension, i.e., diastolic greater than 100 mm/Hg. (Patients with hypertension who are well controlled on medication are eligible for entry.) *History of cardiac disease:* - myocardial infarction documented as a clinical diagnosis or by EKG or any other tests; - documented congestive heart failure; or - documented cardiomyopathy.
    Description

    Cardiac disease that would preclude the use of Adriamycin, Taxol or Herceptin. This includes: *Active cardiac disease:* - angina pectoris that requires the use of antianginal medication; - cardiac arrhythmia requiring medication; - severe conduction abnormality; - clinically significant valvular disease; - cardiomegaly on chest x-ray; - ventricular hypertrophy on EKG; or - patients with poorly controlled hypertension, i.e., diastolic greater than 100 mm/Hg. (Patients with hypertension who are well controlled on medication are eligible for entry.) *History of cardiac disease:* - myocardial infarction documented as a clinical diagnosis or by EKG or any other tests; - documented congestive heart failure; or - documented cardiomyopathy.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018799
    UMLS CUI [1,2]
    C2828389
    UMLS CUI [1,3]
    C0087111
    UMLS CUI [1,4]
    C0085752
    UMLS CUI [1,5]
    C0678133
    UMLS CUI [1,6]
    C0338204
    UMLS CUI [2,1]
    C0002962
    UMLS CUI [2,2]
    C1514873
    UMLS CUI [2,3]
    C0585942
    UMLS CUI [2,4]
    C0003811
    UMLS CUI [2,5]
    C1514873
    UMLS CUI [2,6]
    C0013227
    UMLS CUI [2,7]
    C1842820
    UMLS CUI [2,8]
    C3258293
    UMLS CUI [2,9]
    C2985739
    UMLS CUI [2,10]
    C2073463
    UMLS CUI [2,11]
    C2911650
    UMLS CUI [2,12]
    C0421190
    UMLS CUI [2,13]
    C0428883
    UMLS CUI [3,1]
    C0262926
    UMLS CUI [3,2]
    C0018799
    UMLS CUI [3,3]
    C0027051
    UMLS CUI [3,4]
    C0920316
    UMLS CUI [3,5]
    C0332140
    UMLS CUI [3,6]
    C1623258
    UMLS CUI [3,7]
    C0018802
    UMLS CUI [3,8]
    C0878544
    Psychiatric or addictive disorders that would preclude obtaining informed consent.
    Description

    Psychiatric or addictive disorders that would preclude obtaining informed consent.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0004936
    UMLS CUI [1,2]
    C0700285
    UMLS CUI [1,3]
    C2828389
    UMLS CUI [1,4]
    C0514044
    Pregnancy or lactation at the time of proposed randomization. This protocol excludes pregnant or lactating women based on the fetal toxicity of both tamoxifen and Taxol which are listed as Pregnancy Category D agents. Pregnant women who received tamoxifen have experienced fetal deaths, birth defects, spontaneous abortions, and vaginal bleeding. Women of reproductive potential must agree to use an effective barrier method of contraception. Hormonal birth control methods are not permitted.
    Description

    Pregnancy or lactation at the time of proposed randomization. This protocol excludes pregnant or lactating women based on the fetal toxicity of both tamoxifen and Taxol which are listed as Pregnancy Category D agents. Pregnant women who received tamoxifen have experienced fetal deaths, birth defects, spontaneous abortions, and vaginal bleeding. Women of reproductive potential must agree to use an effective barrier method of contraception. Hormonal birth control methods are not permitted.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0006147
    UMLS CUI [1,3]
    C1442880
    UMLS CUI [1,4]
    C0034656
    UMLS CUI [2,1]
    C2348563
    UMLS CUI [2,2]
    C2828389
    UMLS CUI [2,3]
    C0032961
    UMLS CUI [2,4]
    C0006147
    UMLS CUI [2,5]
    C5230224
    UMLS CUI [2,6]
    C0039286
    UMLS CUI [2,7]
    C0678133
    UMLS CUI [2,8]
    C5707737
    UMLS CUI [3,1]
    C0033011
    UMLS CUI [3,2]
    C0087111
    UMLS CUI [3,3]
    C0039286
    UMLS CUI [3,4]
    C0015927
    UMLS CUI [3,5]
    C0220810
    UMLS CUI [3,6]
    C0000786
    UMLS CUI [3,7]
    C0578503
    UMLS CUI [4,1]
    C4324275
    UMLS CUI [4,2]
    C0680240
    UMLS CUI [4,3]
    C0004764
    UMLS CUI [4,4]
    C1704419
    UMLS CUI [5,1]
    C2985296
    UMLS CUI [5,2]
    C1518422
    UMLS CUI [5,3]
    C0332149
    Sensory/motor neuropathy ≥ grade 2, as defined by the NCI's Common Toxicity Criteria version 2.0.
    Description

    Sensory/motor neuropathy ≥ grade 2, as defined by the NCI's Common Toxicity Criteria version 2.0.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0151313
    UMLS CUI [1,2]
    C0235025
    UMLS CUI [1,3]
    C1511980
    UMLS CUI [1,4]
    C1513882
    UMLS CUI [1,5]
    C0013221
    Contraindications to corticosteroid use which, in the opinion of the investigator, would preclude participation in this study.
    Description

    Contraindications to corticosteroid use which, in the opinion of the investigator, would preclude participation in this study.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1301624
    UMLS CUI [1,2]
    C0239126
    UMLS CUI [1,3]
    C0600219
    UMLS CUI [1,4]
    C2828389
    Concurrent treatment with other investigational agents.
    Description

    Concurrent treatment with other investigational agents.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205420
    UMLS CUI [1,2]
    C0087111
    UMLS CUI [1,3]
    C1875319
    Sensitivity to benzyl alcohol.
    Description

    Sensitivity to benzyl alcohol.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005101
    UMLS CUI [1,2]
    C1511883
    *Special conditions for ineligibility of lumpectomy patients: irradiation and surgery* For patients treated by lumpectomy with axillary dissection, breast irradiation is required. In addition, the following patients will also be ineligible:
    Description

    *Special conditions for ineligibility of lumpectomy patients: irradiation and surgery* For patients treated by lumpectomy with axillary dissection, breast irradiation is required. In addition, the following patients will also be ineligible:

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1512714
    UMLS CUI [1,2]
    C0348080
    UMLS CUI [1,3]
    C5236034
    UMLS CUI [1,4]
    C1522449
    UMLS CUI [1,5]
    C0543467
    UMLS CUI [2,1]
    C5236034
    UMLS CUI [2,2]
    C0193867
    UMLS CUI [2,3]
    C2148528
    UMLS CUI [2,4]
    C1514873
    UMLS CUI [3,1]
    C1524062
    UMLS CUI [3,2]
    C1512714
    Patients with diffuse tumors (as demonstrated on mammography) that would not be considered surgically amenable to lumpectomy.
    Description

    Patients with diffuse tumors (as demonstrated on mammography) that would not be considered surgically amenable to lumpectomy.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1276429
    UMLS CUI [1,2]
    C0024671
    UMLS CUI [1,3]
    C0038894
    UMLS CUI [1,4]
    C3900053
    UMLS CUI [1,5]
    C0851238
    Patients treated with lumpectomy in whom there is another clinically dominant mass or mammographically suspicious abnormality within the ipsilateral breast remnant. Such a mass must be biopsied and demonstrated to be histologically benign prior to randomization or, if malignant, must be surgically removed with clear margins.
    Description

    Patients treated with lumpectomy in whom there is another clinically dominant mass or mammographically suspicious abnormality within the ipsilateral breast remnant. Such a mass must be biopsied and demonstrated to be histologically benign prior to randomization or, if malignant, must be surgically removed with clear margins.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C5236034
    UMLS CUI [1,2]
    C1527180
    UMLS CUI [1,3]
    C0333895
    UMLS CUI [1,4]
    C0024671
    UMLS CUI [1,5]
    C0441989
    UMLS CUI [1,6]
    C0006141
    UMLS CUI [1,7]
    C4554476
    UMLS CUI [2,1]
    C0024103
    UMLS CUI [2,2]
    C0005558
    UMLS CUI [2,3]
    C0205183
    UMLS CUI [2,4]
    C0205462
    UMLS CUI [2,5]
    C5421123
    UMLS CUI [2,6]
    C0205282
    UMLS CUI [2,7]
    C0332644
    UMLS CUI [2,8]
    C0587859
    Patients in whom the margins of the resected specimen are involved with invasive tumor or ductal carcinoma in situ (DCIS). Additional surgical resections to obtain free margins are allowed. Patients in whom tumor is still present after the additional resection(s) must undergo mastectomy to be eligible.
    Description

    Patients in whom the margins of the resected specimen are involved with invasive tumor or ductal carcinoma in situ (DCIS). Additional surgical resections to obtain free margins are allowed. Patients in whom tumor is still present after the additional resection(s) must undergo mastectomy to be eligible.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0332649
    UMLS CUI [1,2]
    C0007124
    UMLS CUI [2,1]
    C1706711
    UMLS CUI [2,2]
    C1285405
    UMLS CUI [2,3]
    C0683607
    UMLS CUI [3,1]
    C4551347
    UMLS CUI [3,2]
    C0231290
    UMLS CUI [3,3]
    C1706711
    UMLS CUI [3,4]
    C0024881
    UMLS CUI [3,5]
    C0013893
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    Similar models

    Eligibility Criteria

    5 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Inclusion and exclusion criteria
    C1512693 (UMLS CUI [1,1])
    C0680251 (UMLS CUI [1,2])
    **Conditions for Eligibility to the Gene Expression Study**
    Item
    **Conditions for Eligibility to the Gene Expression Study**
    boolean
    C1516637 (UMLS CUI [1,1])
    Consented to future cancer research
    Item
    Consented to future cancer research
    boolean
    C5446093 (UMLS CUI [1,1])
    C0016884 (UMLS CUI [1,2])
    Available tumor block
    Item
    Available tumor block
    boolean
    C0470187 (UMLS CUI [1,1])
    C3273930 (UMLS CUI [1,2])
    Known ER status
    Item
    Known ER status
    boolean
    C2919271 (UMLS CUI [1,1])
    Known number of positive nodes
    Item
    Known number of positive nodes
    boolean
    C4086646 (UMLS CUI [1,1])
    *PATIENT ELIGIBILITY AND INELIGIBILITY* *Conditions for patient eligibility* Female patients who satisfy all of the following conditions are the only patients who will be eligible for this study:Elig.phs000826.v1.p1.6
    Item
    *PATIENT ELIGIBILITY AND INELIGIBILITY* *Conditions for patient eligibility* Female patients who satisfy all of the following conditions are the only patients who will be eligible for this study:
    boolean
    C0013893 (UMLS CUI [1,1])
    C0043210 (UMLS CUI [1,2])
    The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines.
    Item
    The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines.
    boolean
    C0021430 (UMLS CUI [1,1])
    C0742766 (UMLS CUI [1,2])
    C0009797 (UMLS CUI [1,3])
    C0750484 (UMLS CUI [1,4])
    C0162791 (UMLS CUI [1,5])
    The patient must have a life expectancy of at least 10 years, excluding her diagnosis of breast cancer. (Comorbid conditions should be taken into consideration, but not the diagnosis of breast cancer.)
    Item
    The patient must have a life expectancy of at least 10 years, excluding her diagnosis of breast cancer. (Comorbid conditions should be taken into consideration, but not the diagnosis of breast cancer.)
    boolean
    C0023671 (UMLS CUI [1,1])
    C0332168 (UMLS CUI [1,2])
    C2828389 (UMLS CUI [1,3])
    C0011900 (UMLS CUI [1,4])
    C0006142 (UMLS CUI [1,5])
    C1275743 (UMLS CUI [2,1])
    C0518609 (UMLS CUI [2,2])
    The interval between the last surgery for breast cancer treatment (lumpectomy, mastectomy, axillary dissection, or re-excision of lumpectomy margins) and randomization must be less than or equal to 84 days.
    Item
    The interval between the last surgery for breast cancer treatment (lumpectomy, mastectomy, axillary dissection, or re-excision of lumpectomy margins) and randomization must be less than or equal to 84 days.
    boolean
    C0332168 (UMLS CUI [1,1])
    C1517741 (UMLS CUI [1,2])
    C0543467 (UMLS CUI [1,3])
    C1511300 (UMLS CUI [1,4])
    C0851238 (UMLS CUI [1,5])
    C0024881 (UMLS CUI [1,6])
    C0193867 (UMLS CUI [1,7])
    C0184913 (UMLS CUI [1,8])
    C0034656 (UMLS CUI [1,9])
    All of the following staging criteria must be met: - Primary tumor must be T1-3 by *clinical* and *pathologic* evaluation. - Ipsilateral nodes must be cN0-1 by *clinical* evaluation. - Ipsilateral nodes must be pN1, pN2a, or pN3a by *pathologic* evaluation. - M0
    Item
    All of the following staging criteria must be met: - Primary tumor must be T1-3 by *clinical* and *pathologic* evaluation. - Ipsilateral nodes must be cN0-1 by *clinical* evaluation. - Ipsilateral nodes must be pN1, pN2a, or pN3a by *pathologic* evaluation. - M0
    boolean
    C0027646 (UMLS CUI [1,1])
    C5444992 (UMLS CUI [1,2])
    C0677930 (UMLS CUI [1,3])
    C1270004 (UMLS CUI [1,4])
    C1275863 (UMLS CUI [1,5])
    C5761362 (UMLS CUI [2,1])
    C0441962 (UMLS CUI [2,2])
    C4084924 (UMLS CUI [2,3])
    C0030664 (UMLS CUI [2,4])
    Patients must have undergone either a total mastectomy and an axillary dissection or a lumpectomy and an axillary dissection. Sentinel node biopsy is permitted, but must be followed by an axillary dissection.
    Item
    Patients must have undergone either a total mastectomy and an axillary dissection or a lumpectomy and an axillary dissection. Sentinel node biopsy is permitted, but must be followed by an axillary dissection.
    boolean
    C2960728 (UMLS CUI [1,1])
    C0851238 (UMLS CUI [1,2])
    C0193867 (UMLS CUI [1,3])
    C0796693 (UMLS CUI [1,4])
    The tumor must be invasive adenocarcinoma on histologic examination.
    Item
    The tumor must be invasive adenocarcinoma on histologic examination.
    boolean
    C0858252 (UMLS CUI [1,1])
    C0205281 (UMLS CUI [1,2])
    C0205462 (UMLS CUI [1,3])
    C4321457 (UMLS CUI [1,4])
    The tumor must be determined to be HER2-positive prior to randomization. Assays performed using fluorescent in situ hybridization (FISH) require gene amplification to be eligible. Assays using immunohistochemistry (IHC) must be performed at an NSABP-approved reference laboratory and require a strongly positive staining score (See Section 9.0).
    Item
    The tumor must be determined to be HER2-positive prior to randomization. Assays performed using fluorescent in situ hybridization (FISH) require gene amplification to be eligible. Assays using immunohistochemistry (IHC) must be performed at an NSABP-approved reference laboratory and require a strongly positive staining score (See Section 9.0).
    boolean
    C1960398 (UMLS CUI [1,1])
    C5421123 (UMLS CUI [1,2])
    C0162789 (UMLS CUI [1,3])
    C0017256 (UMLS CUI [1,4])
    C0013893 (UMLS CUI [1,5])
    C0021044 (UMLS CUI [2,1])
    C1513905 (UMLS CUI [2,2])
    C1532342 (UMLS CUI [2,3])
    C5784376 (UMLS CUI [2,4])
    C1704680 (UMLS CUI [2,5])
    Patients must have an analysis of both estrogen and progesterone receptors performed on the primary tumor prior to randomization (see Section 10.0). "Marginal," "borderline," etc., results (i.e., those not definitely negative) will also be considered positive regardless of the methodology used.
    Item
    Patients must have an analysis of both estrogen and progesterone receptors performed on the primary tumor prior to randomization (see Section 10.0). "Marginal," "borderline," etc., results (i.e., those not definitely negative) will also be considered positive regardless of the methodology used.
    boolean
    C1440607 (UMLS CUI [1,1])
    C0936012 (UMLS CUI [1,2])
    C0677930 (UMLS CUI [1,3])
    C5421123 (UMLS CUI [1,4])
    C0205284 (UMLS CUI [2,1])
    C0205189 (UMLS CUI [2,2])
    C0750591 (UMLS CUI [2,3])
    C1446409 (UMLS CUI [2,4])
    C3641650 (UMLS CUI [2,5])
    C3266812 (UMLS CUI [2,6])
    At the time of randomization, the patient must have had the following: history and physical exam, EKG, and PA and lateral chest x-ray within the past 3 months; and a bilateral mammogram (or unilateral if patient has had a mastectomy) and a pelvic exam (for women who have a uterus and who will be taking tamoxifen) within the past year.
    Item
    At the time of randomization, the patient must have had the following: history and physical exam, EKG, and PA and lateral chest x-ray within the past 3 months; and a bilateral mammogram (or unilateral if patient has had a mastectomy) and a pelvic exam (for women who have a uterus and who will be taking tamoxifen) within the past year.
    boolean
    C0034656 (UMLS CUI [1,1])
    C1442880 (UMLS CUI [1,2])
    C0262926 (UMLS CUI [1,3])
    C0031809 (UMLS CUI [1,4])
    C1623258 (UMLS CUI [1,5])
    C5159055 (UMLS CUI [1,6])
    C4086725 (UMLS CUI [1,7])
    C2236946 (UMLS CUI [1,8])
    C0200045 (UMLS CUI [1,9])
    C3887293 (UMLS CUI [1,10])
    Within 3 months prior to entry, the patient must have a baseline LVEF measured by MUGA scan equal to or greater than the lower limit of normal for the radiology facility. (If LVEF is > 75%, the investigator should consider having the LVEF determination reviewed prior to randomization. Following randomization, the LVEF determination may be reviewed up until the time of the post-AC MUGA.
    Item
    Within 3 months prior to entry, the patient must have a baseline LVEF measured by MUGA scan equal to or greater than the lower limit of normal for the radiology facility. (If LVEF is > 75%, the investigator should consider having the LVEF determination reviewed prior to randomization. Following randomization, the LVEF determination may be reviewed up until the time of the post-AC MUGA.
    boolean
    C4086725 (UMLS CUI [1,1])
    C1442488 (UMLS CUI [1,2])
    C3837267 (UMLS CUI [1,3])
    C0521317 (UMLS CUI [1,4])
    C0439091 (UMLS CUI [1,5])
    C1518030 (UMLS CUI [1,6])
    C3844340 (UMLS CUI [1,7])
    C3837267 (UMLS CUI [2,1])
    C1709940 (UMLS CUI [2,2])
    C0034656 (UMLS CUI [2,3])
    C0521317 (UMLS CUI [2,4])
    At the time of randomization: - The postoperative absolute neutrophil count (ANC) must be ≥ 1500/mm3 (or <1500/mm3 if, in the opinion of the investigator, this represents an ethnic or racial variation of normal). - Postoperative platelet count must be ≥ 100,000/mm3. Significant underlying hematologic disorders must be excluded when the platelet count is above the upper limit of normal for the lab. - There must be postoperative evidence of adequate hepatic function, i.e., a. total bilirubin must be ≤ ULN for the lab unless the patient has a chronic grade 1 bilirubin elevation (>ULN to ≤1.5 x ULN) due to Gilbert's disease or similar syndrome; and b. alkaline phosphatase must be <2.5 times the ULN for the lab; and the SGOT [AST] must be <1.5 times the ULN for the lab. - There must be postoperative evidence of adequate renal function (serum creatinine within or less than the institution's normal range).
    Item
    At the time of randomization: - The postoperative absolute neutrophil count (ANC) must be ≥ 1500/mm3 (or <1500/mm3 if, in the opinion of the investigator, this represents an ethnic or racial variation of normal). - Postoperative platelet count must be ≥ 100,000/mm3. Significant underlying hematologic disorders must be excluded when the platelet count is above the upper limit of normal for the lab. - There must be postoperative evidence of adequate hepatic function, i.e., a. total bilirubin must be ≤ ULN for the lab unless the patient has a chronic grade 1 bilirubin elevation (>ULN to ≤1.5 x ULN) due to Gilbert's disease or similar syndrome; and b. alkaline phosphatase must be <2.5 times the ULN for the lab; and the SGOT [AST] must be <1.5 times the ULN for the lab. - There must be postoperative evidence of adequate renal function (serum creatinine within or less than the institution's normal range).
    boolean
    C1442880 (UMLS CUI [1,1])
    C0034656 (UMLS CUI [1,2])
    C0032790 (UMLS CUI [1,3])
    C1699112 (UMLS CUI [1,4])
    C1521895 (UMLS CUI [1,5])
    C0600219 (UMLS CUI [1,6])
    C0032790 (UMLS CUI [2,1])
    C0836924 (UMLS CUI [2,2])
    C1546944 (UMLS CUI [2,3])
    C0018939 (UMLS CUI [2,4])
    C1277606 (UMLS CUI [2,5])
    C0032790 (UMLS CUI [3,1])
    C5554846 (UMLS CUI [3,2])
    C0205411 (UMLS CUI [3,3])
    C0232741 (UMLS CUI [3,4])
    C0201913 (UMLS CUI [3,5])
    C0002059 (UMLS CUI [3,6])
    C0004002 (UMLS CUI [3,7])
    C3163633 (UMLS CUI [3,8])
    C1519815 (UMLS CUI [3,9])
    C4685048 (UMLS CUI [3,10])
    C0017551 (UMLS CUI [3,11])
    C0032790 (UMLS CUI [4,1])
    C5554846 (UMLS CUI [4,2])
    C0232804 (UMLS CUI [4,3])
    C0600061 (UMLS CUI [4,4])
    C0086715 (UMLS CUI [4,5])
    Patients must have no clinical or radiologic evidence of metastatic disease. Suspicious findings must be confirmed as benign by radiologic evaluation or biopsy. A patient with skeletal pain is eligible for inclusion in the study if bone scan and/or roentgenological examination fails to disclose metastatic disease.
    Item
    Patients must have no clinical or radiologic evidence of metastatic disease. Suspicious findings must be confirmed as benign by radiologic evaluation or biopsy. A patient with skeletal pain is eligible for inclusion in the study if bone scan and/or roentgenological examination fails to disclose metastatic disease.
    boolean
    C1711337 (UMLS CUI [1,1])
    C2939420 (UMLS CUI [1,2])
    C0005558 (UMLS CUI [1,3])
    C0750484 (UMLS CUI [1,4])
    C0086692 (UMLS CUI [1,5])
    C0151825 (UMLS CUI [2,1])
    C0680253 (UMLS CUI [2,2])
    C0855682 (UMLS CUI [2,3])
    C0043299 (UMLS CUI [2,4])
    C5785236 (UMLS CUI [2,5])
    C2939420 (UMLS CUI [2,6])
    Patients with a history of *non-breast* malignancies are eligible if they have been disease-free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
    Item
    Patients with a history of *non-breast* malignancies are eligible if they have been disease-free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
    boolean
    C0262926 (UMLS CUI [1,1])
    C0006826 (UMLS CUI [1,2])
    C1518422 (UMLS CUI [1,3])
    C0006141 (UMLS CUI [1,4])
    C1548635 (UMLS CUI [1,5])
    C5401422 (UMLS CUI [1,6])
    C3843495 (UMLS CUI [1,7])
    C0332152 (UMLS CUI [1,8])
    C0034656 (UMLS CUI [1,9])
    C0600219 (UMLS CUI [1,10])
    C2986492 (UMLS CUI [1,11])
    C0205251 (UMLS CUI [1,12])
    C1548635 (UMLS CUI [2,1])
    C0006826 (UMLS CUI [2,2])
    C0011900 (UMLS CUI [2,3])
    C0087111 (UMLS CUI [2,4])
    C0332168 (UMLS CUI [2,5])
    C0851140 (UMLS CUI [2,6])
    C0346040 (UMLS CUI [2,7])
    C4721806 (UMLS CUI [2,8])
    C0007137 (UMLS CUI [2,9])
    Prior to randomization, the investigator must designate whether the patients who had a lumpectomy will receive local or locoregional radiation therapy. For patients who had a mastectomy, the investigator must designate whether or not the patient will receive radiation therapy. (Pre-randomization discussion and/or consultation with a radiation oncologist is encouraged.) Note: *Irradiation of any internal mammary nodes is prohibited in this trial.* *Special conditions for eligibility of lumpectomy patients: irradiation and surgery* Patients treated by lumpectomy and axillary node dissection to be followed by breast radiation therapy must meet all the eligibility criteria in above in addition to the following:
    Item
    Prior to randomization, the investigator must designate whether the patients who had a lumpectomy will receive local or locoregional radiation therapy. For patients who had a mastectomy, the investigator must designate whether or not the patient will receive radiation therapy. (Pre-randomization discussion and/or consultation with a radiation oncologist is encouraged.) Note: *Irradiation of any internal mammary nodes is prohibited in this trial.* *Special conditions for eligibility of lumpectomy patients: irradiation and surgery* Patients treated by lumpectomy and axillary node dissection to be followed by breast radiation therapy must meet all the eligibility criteria in above in addition to the following:
    boolean
    C0332152 (UMLS CUI [1,1])
    C0034656 (UMLS CUI [1,2])
    C1521895 (UMLS CUI [1,3])
    C5420090 (UMLS CUI [1,4])
    C0262926 (UMLS CUI [1,5])
    C0851238 (UMLS CUI [1,6])
    C1522449 (UMLS CUI [1,7])
    C1517925 (UMLS CUI [1,8])
    C3846158 (UMLS CUI [1,9])
    C1521895 (UMLS CUI [2,1])
    C5420090 (UMLS CUI [2,2])
    C0262926 (UMLS CUI [2,3])
    C0024881 (UMLS CUI [2,4])
    C1522449 (UMLS CUI [2,5])
    C0683610 (UMLS CUI [3,1])
    C1522449 (UMLS CUI [3,2])
    C0447180 (UMLS CUI [3,3])
    C2599718 (UMLS CUI [3,4])
    C1516637 (UMLS CUI [4,1])
    C5236034 (UMLS CUI [4,2])
    C1522449 (UMLS CUI [4,3])
    C0543467 (UMLS CUI [4,4])
    C0851238 (UMLS CUI [5,1])
    C0193867 (UMLS CUI [5,2])
    C0332283 (UMLS CUI [5,3])
    C1522449 (UMLS CUI [5,4])
    C0006141 (UMLS CUI [5,5])
    C1516637 (UMLS CUI [5,6])
    Generally, lumpectomy should be reserved for tumors <5 cm. However, at the investigator's discretion, patients treated with lumpectomy for tumors ≥ 5 cm are eligible.
    Item
    Generally, lumpectomy should be reserved for tumors <5 cm. However, at the investigator's discretion, patients treated with lumpectomy for tumors ≥ 5 cm are eligible.
    boolean
    C0851238 (UMLS CUI [1,1])
    C5769400 (UMLS CUI [1,2])
    C5441575 (UMLS CUI [1,3])
    C1521895 (UMLS CUI [1,4])
    C5556474 (UMLS CUI [1,5])
    The margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist. In patients in whom pathologic examination demonstrates tumor present at the line of resection, additional operative procedures may be performed to obtain clear margins. This is permissible even if axillary dissection has been performed. Patients in whom tumor is still present at the resected margin after re-excision(s) must undergo total mastectomy to be eligible.
    Item
    The margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist. In patients in whom pathologic examination demonstrates tumor present at the line of resection, additional operative procedures may be performed to obtain clear margins. This is permissible even if axillary dissection has been performed. Patients in whom tumor is still present at the resected margin after re-excision(s) must undergo total mastectomy to be eligible.
    boolean
    C1709157 (UMLS CUI [1,1])
    C0007124 (UMLS CUI [1,2])
    C0332142 (UMLS CUI [1,3])
    Whole breast irradiation is required. Irradiation of regional lymph nodes is optional, *but partial breast irradiation and irradiation of any internal mammary nodes are prohibited in this trial.* Intent to irradiate the axilla or other regional node groups must be declared by the investigator prior to randomization for stratification purposes. Please see guidelines for radiotherapy in Appendix A. *Special conditions for eligibility of mastectomy patients: irradiation* The decision to use locoregional irradiation in patients who have undergone total mastectomy and axillary node dissection must be declared by the investigator prior to randomization for stratification purposes. Failure to adhere to the radiation therapy plan will be a protocol violation. Also note that *irradiation of any internal mammary nodes is prohibited in this trial.*
    Item
    Whole breast irradiation is required. Irradiation of regional lymph nodes is optional, *but partial breast irradiation and irradiation of any internal mammary nodes are prohibited in this trial.* Intent to irradiate the axilla or other regional node groups must be declared by the investigator prior to randomization for stratification purposes. Please see guidelines for radiotherapy in Appendix A. *Special conditions for eligibility of mastectomy patients: irradiation* The decision to use locoregional irradiation in patients who have undergone total mastectomy and axillary node dissection must be declared by the investigator prior to randomization for stratification purposes. Failure to adhere to the radiation therapy plan will be a protocol violation. Also note that *irradiation of any internal mammary nodes is prohibited in this trial.*
    boolean
    C3897169 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C4759292 (UMLS CUI [1,3])
    C1518600 (UMLS CUI [1,4])
    C3897989 (UMLS CUI [1,5])
    C0447180 (UMLS CUI [1,6])
    C1522449 (UMLS CUI [1,7])
    C0683610 (UMLS CUI [1,8])
    C2599718 (UMLS CUI [1,9])
    C1292734 (UMLS CUI [2,1])
    C1522449 (UMLS CUI [2,2])
    C0004454 (UMLS CUI [2,3])
    C1179441 (UMLS CUI [2,4])
    *Conditions for patient ineligibility* Male patients are not eligible for this study. Patients with one or more of the following conditions or prior therapies are also ineligible for this study:
    Item
    *Conditions for patient ineligibility* Male patients are not eligible for this study. Patients with one or more of the following conditions or prior therapies are also ineligible for this study:
    boolean
    C1512714 (UMLS CUI [1,1])
    C0348080 (UMLS CUI [1,2])
    C0086582 (UMLS CUI [1,3])
    C0332132 (UMLS CUI [1,4])
    C1514463 (UMLS CUI [1,5])
    C1265611 (UMLS CUI [1,6])
    Bilateral malignancy or a mass or mammographic abnormality in the opposite breast suspicious for malignancy unless there is biopsy proof that the mass is not malignant.
    Item
    Bilateral malignancy or a mass or mammographic abnormality in the opposite breast suspicious for malignancy unless there is biopsy proof that the mass is not malignant.
    boolean
    C0238767 (UMLS CUI [1,1])
    C0006826 (UMLS CUI [1,2])
    C0024103 (UMLS CUI [1,3])
    C0441988 (UMLS CUI [1,4])
    C0262365 (UMLS CUI [1,5])
    C4050405 (UMLS CUI [1,6])
    C0332300 (UMLS CUI [1,7])
    C1334932 (UMLS CUI [1,8])
    C0405352 (UMLS CUI [1,9])
    Primary tumor staged as T4 for any reason
    Item
    Primary tumor staged as T4 for any reason
    boolean
    C0677930 (UMLS CUI [1,1])
    C0475751 (UMLS CUI [1,2])
    Nodes staged as *clinical* N2 or N3 for any reason and nodes staged as *pathologic* pN2b, pN3b, or pN3c.
    Item
    Nodes staged as *clinical* N2 or N3 for any reason and nodes staged as *pathologic* pN2b, pN3b, or pN3c.
    boolean
    C5702804 (UMLS CUI [1,1])
    C5702667 (UMLS CUI [1,2])
    C1711122 (UMLS CUI [1,3])
    C1711125 (UMLS CUI [1,4])
    C1711126 (UMLS CUI [1,5])
    aPrior history of breast cancer, including DCIS (patients with a history of LCIS are eligible).
    Item
    Prior history of breast cancer, including DCIS (patients with a history of LCIS are eligible).
    boolean
    C0262926 (UMLS CUI [1,1])
    C0006142 (UMLS CUI [1,2])
    C0007124 (UMLS CUI [1,3])
    C0262926 (UMLS CUI [2,1])
    C0279563 (UMLS CUI [2,2])
    C1548635 (UMLS CUI [2,3])
    Treatment including radiation therapy, chemotherapy, biotherapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to randomization. The only exception is hormonal therapy, which may have been given for up to a total of 28 days anytime after diagnosis and before randomization. In such a case, hormonal therapy must stop at or before randomization and be re-started if indicated following chemotherapy.
    Item
    Treatment including radiation therapy, chemotherapy, biotherapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to randomization. The only exception is hormonal therapy, which may have been given for up to a total of 28 days anytime after diagnosis and before randomization. In such a case, hormonal therapy must stop at or before randomization and be re-started if indicated following chemotherapy.
    boolean
    C0087111 (UMLS CUI [1,1])
    C1522449 (UMLS CUI [1,2])
    C3665472 (UMLS CUI [1,3])
    C0005527 (UMLS CUI [1,4])
    C0279025 (UMLS CUI [1,5])
    C5421123 (UMLS CUI [1,6])
    C0521116 (UMLS CUI [1,7])
    C0920688 (UMLS CUI [1,8])
    C1705847 (UMLS CUI [2,1])
    C0279025 (UMLS CUI [2,2])
    C0332168 (UMLS CUI [2,3])
    C0231290 (UMLS CUI [2,4])
    C0920688 (UMLS CUI [2,5])
    C1947925 (UMLS CUI [2,6])
    C5421123 (UMLS CUI [2,7])
    C0580673 (UMLS CUI [3,1])
    C3146298 (UMLS CUI [3,2])
    C0332282 (UMLS CUI [3,3])
    C3665472 (UMLS CUI [3,4])
    Prior anthracycline or taxane therapy for any malignancy.
    Item
    Prior anthracycline or taxane therapy for any malignancy.
    boolean
    C0278941 (UMLS CUI [1,1])
    C1514463 (UMLS CUI [1,2])
    C0796419 (UMLS CUI [1,3])
    C0006826 (UMLS CUI [1,4])
    Any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. (These patients are eligible only if this therapy is discontinued prior to randomization.)
    Item
    Any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. (These patients are eligible only if this therapy is discontinued prior to randomization.)
    boolean
    C1514463 (UMLS CUI [1,1])
    C0279025 (UMLS CUI [1,2])
    C0036884 (UMLS CUI [1,3])
    C0240604 (UMLS CUI [1,4])
    C0282402 (UMLS CUI [1,5])
    C1548635 (UMLS CUI [2,1])
    C1555300 (UMLS CUI [2,2])
    C5421123 (UMLS CUI [2,3])
    Therapy with any hormonal agents such as raloxifene (Evista®), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or prevention. (Patients are eligible only if these medications are discontinued prior to randomization. These medications are not permitted while on the study except for the use of tamoxifen.)
    Item
    Therapy with any hormonal agents such as raloxifene (Evista®), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or prevention. (Patients are eligible only if these medications are discontinued prior to randomization. These medications are not permitted while on the study except for the use of tamoxifen.)
    boolean
    C0279025 (UMLS CUI [1,1])
    C0244404 (UMLS CUI [1,2])
    C0039286 (UMLS CUI [1,3])
    C0732611 (UMLS CUI [1,4])
    C2114408 (UMLS CUI [1,5])
    C3650929 (UMLS CUI [1,6])
    C1548635 (UMLS CUI [2,1])
    C1444662 (UMLS CUI [2,2])
    C5421123 (UMLS CUI [2,3])
    C3242263 (UMLS CUI [3,1])
    C0947630 (UMLS CUI [3,2])
    C0332300 (UMLS CUI [3,3])
    C1524063 (UMLS CUI [3,4])
    C0039286 (UMLS CUI [3,5])
    Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude a patient from being subjected to any of the treatment options or would prevent prolonged follow-up.
    Item
    Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude a patient from being subjected to any of the treatment options or would prevent prolonged follow-up.
    boolean
    C5669530 (UMLS CUI [1,1])
    C0007222 (UMLS CUI [1,2])
    C0022658 (UMLS CUI [1,3])
    C0023895 (UMLS CUI [1,4])
    C2828389 (UMLS CUI [1,5])
    C0683525 (UMLS CUI [1,6])
    C0439590 (UMLS CUI [1,7])
    C0589120 (UMLS CUI [1,8])
    Cardiac disease that would preclude the use of Adriamycin, Taxol or Herceptin. This includes: *Active cardiac disease:* - angina pectoris that requires the use of antianginal medication; - cardiac arrhythmia requiring medication; - severe conduction abnormality; - clinically significant valvular disease; - cardiomegaly on chest x-ray; - ventricular hypertrophy on EKG; or - patients with poorly controlled hypertension, i.e., diastolic greater than 100 mm/Hg. (Patients with hypertension who are well controlled on medication are eligible for entry.) *History of cardiac disease:* - myocardial infarction documented as a clinical diagnosis or by EKG or any other tests; - documented congestive heart failure; or - documented cardiomyopathy.
    Item
    Cardiac disease that would preclude the use of Adriamycin, Taxol or Herceptin. This includes: *Active cardiac disease:* - angina pectoris that requires the use of antianginal medication; - cardiac arrhythmia requiring medication; - severe conduction abnormality; - clinically significant valvular disease; - cardiomegaly on chest x-ray; - ventricular hypertrophy on EKG; or - patients with poorly controlled hypertension, i.e., diastolic greater than 100 mm/Hg. (Patients with hypertension who are well controlled on medication are eligible for entry.) *History of cardiac disease:* - myocardial infarction documented as a clinical diagnosis or by EKG or any other tests; - documented congestive heart failure; or - documented cardiomyopathy.
    boolean
    C0018799 (UMLS CUI [1,1])
    C2828389 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [1,3])
    C0085752 (UMLS CUI [1,4])
    C0678133 (UMLS CUI [1,5])
    C0338204 (UMLS CUI [1,6])
    C0002962 (UMLS CUI [2,1])
    C1514873 (UMLS CUI [2,2])
    C0585942 (UMLS CUI [2,3])
    C0003811 (UMLS CUI [2,4])
    C1514873 (UMLS CUI [2,5])
    C0013227 (UMLS CUI [2,6])
    C1842820 (UMLS CUI [2,7])
    C3258293 (UMLS CUI [2,8])
    C2985739 (UMLS CUI [2,9])
    C2073463 (UMLS CUI [2,10])
    C2911650 (UMLS CUI [2,11])
    C0421190 (UMLS CUI [2,12])
    C0428883 (UMLS CUI [2,13])
    C0262926 (UMLS CUI [3,1])
    C0018799 (UMLS CUI [3,2])
    C0027051 (UMLS CUI [3,3])
    C0920316 (UMLS CUI [3,4])
    C0332140 (UMLS CUI [3,5])
    C1623258 (UMLS CUI [3,6])
    C0018802 (UMLS CUI [3,7])
    C0878544 (UMLS CUI [3,8])
    Psychiatric or addictive disorders that would preclude obtaining informed consent.
    Item
    Psychiatric or addictive disorders that would preclude obtaining informed consent.
    boolean
    C0004936 (UMLS CUI [1,1])
    C0700285 (UMLS CUI [1,2])
    C2828389 (UMLS CUI [1,3])
    C0514044 (UMLS CUI [1,4])
    Pregnancy or lactation at the time of proposed randomization. This protocol excludes pregnant or lactating women based on the fetal toxicity of both tamoxifen and Taxol which are listed as Pregnancy Category D agents. Pregnant women who received tamoxifen have experienced fetal deaths, birth defects, spontaneous abortions, and vaginal bleeding. Women of reproductive potential must agree to use an effective barrier method of contraception. Hormonal birth control methods are not permitted.
    Item
    Pregnancy or lactation at the time of proposed randomization. This protocol excludes pregnant or lactating women based on the fetal toxicity of both tamoxifen and Taxol which are listed as Pregnancy Category D agents. Pregnant women who received tamoxifen have experienced fetal deaths, birth defects, spontaneous abortions, and vaginal bleeding. Women of reproductive potential must agree to use an effective barrier method of contraception. Hormonal birth control methods are not permitted.
    boolean
    C0032961 (UMLS CUI [1,1])
    C0006147 (UMLS CUI [1,2])
    C1442880 (UMLS CUI [1,3])
    C0034656 (UMLS CUI [1,4])
    C2348563 (UMLS CUI [2,1])
    C2828389 (UMLS CUI [2,2])
    C0032961 (UMLS CUI [2,3])
    C0006147 (UMLS CUI [2,4])
    C5230224 (UMLS CUI [2,5])
    C0039286 (UMLS CUI [2,6])
    C0678133 (UMLS CUI [2,7])
    C5707737 (UMLS CUI [2,8])
    C0033011 (UMLS CUI [3,1])
    C0087111 (UMLS CUI [3,2])
    C0039286 (UMLS CUI [3,3])
    C0015927 (UMLS CUI [3,4])
    C0220810 (UMLS CUI [3,5])
    C0000786 (UMLS CUI [3,6])
    C0578503 (UMLS CUI [3,7])
    C4324275 (UMLS CUI [4,1])
    C0680240 (UMLS CUI [4,2])
    C0004764 (UMLS CUI [4,3])
    C1704419 (UMLS CUI [4,4])
    C2985296 (UMLS CUI [5,1])
    C1518422 (UMLS CUI [5,2])
    C0332149 (UMLS CUI [5,3])
    Sensory/motor neuropathy ≥ grade 2, as defined by the NCI's Common Toxicity Criteria version 2.0.
    Item
    Sensory/motor neuropathy ≥ grade 2, as defined by the NCI's Common Toxicity Criteria version 2.0.
    boolean
    C0151313 (UMLS CUI [1,1])
    C0235025 (UMLS CUI [1,2])
    C1511980 (UMLS CUI [1,3])
    C1513882 (UMLS CUI [1,4])
    C0013221 (UMLS CUI [1,5])
    Contraindications to corticosteroid use which, in the opinion of the investigator, would preclude participation in this study.
    Item
    Contraindications to corticosteroid use which, in the opinion of the investigator, would preclude participation in this study.
    boolean
    C1301624 (UMLS CUI [1,1])
    C0239126 (UMLS CUI [1,2])
    C0600219 (UMLS CUI [1,3])
    C2828389 (UMLS CUI [1,4])
    Concurrent treatment with other investigational agents.
    Item
    Concurrent treatment with other investigational agents.
    boolean
    C0205420 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    C1875319 (UMLS CUI [1,3])
    Sensitivity to benzyl alcohol.
    Item
    Sensitivity to benzyl alcohol.
    boolean
    C0005101 (UMLS CUI [1,1])
    C1511883 (UMLS CUI [1,2])
    *Special conditions for ineligibility of lumpectomy patients: irradiation and surgery* For patients treated by lumpectomy with axillary dissection, breast irradiation is required. In addition, the following patients will also be ineligible:
    Item
    *Special conditions for ineligibility of lumpectomy patients: irradiation and surgery* For patients treated by lumpectomy with axillary dissection, breast irradiation is required. In addition, the following patients will also be ineligible:
    boolean
    C1512714 (UMLS CUI [1,1])
    C0348080 (UMLS CUI [1,2])
    C5236034 (UMLS CUI [1,3])
    C1522449 (UMLS CUI [1,4])
    C0543467 (UMLS CUI [1,5])
    C5236034 (UMLS CUI [2,1])
    C0193867 (UMLS CUI [2,2])
    C2148528 (UMLS CUI [2,3])
    C1514873 (UMLS CUI [2,4])
    C1524062 (UMLS CUI [3,1])
    C1512714 (UMLS CUI [3,2])
    Patients with diffuse tumors (as demonstrated on mammography) that would not be considered surgically amenable to lumpectomy.
    Item
    Patients with diffuse tumors (as demonstrated on mammography) that would not be considered surgically amenable to lumpectomy.
    boolean
    C1276429 (UMLS CUI [1,1])
    C0024671 (UMLS CUI [1,2])
    C0038894 (UMLS CUI [1,3])
    C3900053 (UMLS CUI [1,4])
    C0851238 (UMLS CUI [1,5])
    Patients treated with lumpectomy in whom there is another clinically dominant mass or mammographically suspicious abnormality within the ipsilateral breast remnant. Such a mass must be biopsied and demonstrated to be histologically benign prior to randomization or, if malignant, must be surgically removed with clear margins.
    Item
    Patients treated with lumpectomy in whom there is another clinically dominant mass or mammographically suspicious abnormality within the ipsilateral breast remnant. Such a mass must be biopsied and demonstrated to be histologically benign prior to randomization or, if malignant, must be surgically removed with clear margins.
    boolean
    C5236034 (UMLS CUI [1,1])
    C1527180 (UMLS CUI [1,2])
    C0333895 (UMLS CUI [1,3])
    C0024671 (UMLS CUI [1,4])
    C0441989 (UMLS CUI [1,5])
    C0006141 (UMLS CUI [1,6])
    C4554476 (UMLS CUI [1,7])
    C0024103 (UMLS CUI [2,1])
    C0005558 (UMLS CUI [2,2])
    C0205183 (UMLS CUI [2,3])
    C0205462 (UMLS CUI [2,4])
    C5421123 (UMLS CUI [2,5])
    C0205282 (UMLS CUI [2,6])
    C0332644 (UMLS CUI [2,7])
    C0587859 (UMLS CUI [2,8])
    Patients in whom the margins of the resected specimen are involved with invasive tumor or ductal carcinoma in situ (DCIS). Additional surgical resections to obtain free margins are allowed. Patients in whom tumor is still present after the additional resection(s) must undergo mastectomy to be eligible.
    Item
    Patients in whom the margins of the resected specimen are involved with invasive tumor or ductal carcinoma in situ (DCIS). Additional surgical resections to obtain free margins are allowed. Patients in whom tumor is still present after the additional resection(s) must undergo mastectomy to be eligible.
    boolean
    C0332649 (UMLS CUI [1,1])
    C0007124 (UMLS CUI [1,2])
    C1706711 (UMLS CUI [2,1])
    C1285405 (UMLS CUI [2,2])
    C0683607 (UMLS CUI [2,3])
    C4551347 (UMLS CUI [3,1])
    C0231290 (UMLS CUI [3,2])
    C1706711 (UMLS CUI [3,3])
    C0024881 (UMLS CUI [3,4])
    C0013893 (UMLS CUI [3,5])
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