ID

45906

Beskrivning

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.

Länk

dbGaP study = phs000826

Nyckelord

Versioner (1)
  1. 2024-01-16 2024-01-16 - Simon Heim
Rättsinnehavare

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

Uppladdad den

16 januari 2024

DOI

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Licens

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

Engelsk

Eligibility Criteria

5 Formulär  
Inclusion and exclusion criteria
Beskrivning

Inclusion and exclusion criteria

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

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

Datatyp

boolean

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

Consented to future cancer research

Datatyp

boolean

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

Available tumor block

Datatyp

boolean

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

Known ER status

Datatyp

boolean

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

Known number of positive nodes

Datatyp

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:
Beskrivning

*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

Datatyp

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.
Beskrivning

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

Datatyp

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.)
Beskrivning

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.)

Datatyp

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.
Beskrivning

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.

Datatyp

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
Beskrivning

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

Datatyp

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.
Beskrivning

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.

Datatyp

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.
Beskrivning

The tumor must be invasive adenocarcinoma on histologic examination.

Datatyp

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).
Beskrivning

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).

Datatyp

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.
Beskrivning

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.

Datatyp

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.
Beskrivning

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.

Datatyp

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.
Beskrivning

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.

Datatyp

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).
Beskrivning

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).

Datatyp

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.
Beskrivning

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.

Datatyp

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.
Beskrivning

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.

Datatyp

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:
Beskrivning

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:

Datatyp

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.
Beskrivning

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.

Datatyp

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.
Beskrivning

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.

Datatyp

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.*
Beskrivning

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.*

Datatyp

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:
Beskrivning

*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:

Datatyp

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.
Beskrivning

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.

Datatyp

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
Beskrivning

Primary tumor staged as T4 for any reason

Datatyp

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.
Beskrivning

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

Datatyp

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).
Beskrivning

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

Datatyp

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.
Beskrivning

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.

Datatyp

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.
Beskrivning

Prior anthracycline or taxane therapy for any malignancy.

Datatyp

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.)
Beskrivning

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.)

Datatyp

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.)
Beskrivning

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.)

Datatyp

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.
Beskrivning

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.

Datatyp

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.
Beskrivning

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.

Datatyp

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.
Beskrivning

Psychiatric or addictive disorders that would preclude obtaining informed consent.

Datatyp

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.
Beskrivning

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.

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Concurrent treatment with other investigational agents.

Datatyp

boolean

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

Sensitivity to benzyl alcohol.

Datatyp

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:
Beskrivning

*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:

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

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.

Datatyp

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.
Beskrivning

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.

Datatyp

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
Tillbaka till toppen

Similar models

Eligibility Criteria

5 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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