ID

45461

Description

Principal Investigator: Richard Wilson, PhD, Washington University School of Medicine, St. Louis, MO, USA MeSH: https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000472 Highly variable outcomes are observed in patients with estrogen receptor positive (ER+) breast cancer who undergo preoperative estrogen deprivation therapy with aromatase inhibitors (AI). In this study, 46 baseline tumor and normal genomes and 31 baseline tumor/normal exomes of participants selected from two clinical trials of neoadjuvant AI therapy on ER+ breast cancer were sequenced to identify somatic alterations that correlate with response to AI, to screen for therapeutic targets and to elucidate the genetic landscape of ER+ breast cancer. From the same set of patients we later performed deep genomic characterization of a subset of matched primary tumors after four months of AI therapy, generating comprehensive information about the range of changes that occur when ER+ breast cancers are subjected to estrogen deprivation. This data includes whole genome sequence and transcriptome data. To better understand tumor heterogeneity and the evolution of resistance to estrogen-deprivation therapy, a subset of these tumours, along with 38 additional cases were sequenced to greater depth using targeted capture with a gene panel.

Link

dbGap-study=phs000472

Keywords

Versions (2)
  1. 10/24/22 10/24/22 - Simon Heim
  2. 12/12/22 12/12/22 - Kristina Keller
Copyright Holder

Richard Wilson, PhD, Washington University School of Medicine, St. Louis, MO, USA

Uploaded on

December 12, 2022

DOI

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License

Creative Commons BY 4.0
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dbGaP phs000472 Estrogen Receptor Positive Breast Cancer: Aromatase Inhibitor Response Study

English

Eligibility Criteria

6 forms  
  1. StudyEvent: SEV1
    1. Eligibility Criteria
    2. The subject consent data table contains subject IDs, consent group information, and affection status for estrogen receptor positive (ER+) breast cancer.
    3. The subject sample mapping data table includes a mapping of study subject IDs to sample IDs. Samples are the final preps submitted for genotyping, sequencing, and/or expression data. For example, if one patient (subject ID) gave one sample, and that sample was processed differently to generate 2 sequencing runs, there would be two rows, both using the same subject ID, but having 2 unique sample IDs. The data table also includes sample use.
    4. The subject phenotype data table includes age of enrollment (n=1 variable), tumor pathology (n=10 variables; baseline breast cancer luminal subtype, tumor shape, grade, maximum dimension, number of positive nodes, pathological tumor and node stage, and general comments), PEPI RFS score (n=2 variables), WHO clinical response (n=1 variable) and breast cancer biomarkers (n=15 variables; ER+, Ki-67, and Her2).
    5. The sample attributes data table includes sample type, body site where sample was extracted, sample analyte type, histological type, and time of tumor sample collection.
    6. The pre- and post-subject phenotype data table includes age, sequence of events (n=9 variables; event and recurrence of event, adverse event, follow-up time, survival status, and cause of death), surgical status (n=2 variables), tumor pathology (n=6 variables; baseline tumor type and grade, number of positive nodes, node and tumor stage, and tumor dimension), PEPI RFS score (n=2 variables), and breast cancer biomarkers (n=6 variables; Allred ER+ score and Ki-67).
Inclusion and exclusion criteria
Description

Inclusion and exclusion criteria

All tumors sequenced were classified as luminal A or B by PAM50 gene expression profiling. Tumor samples for whole genome sequencing were selected from two clinical trials of neoadjuvant aromatase inhibitor therapy:
Description

All tumors sequenced were classified as luminal A or B by PAM50 gene expression profiling. Tumor samples for whole genome sequencing were selected from two clinical trials of neoadjuvant aromatase inhibitor therapy:

Data type

boolean

Alias
UMLS CUI [1,1]
C3642345
UMLS CUI [1,2]
C3642346
UMLS CUI [1,3]
C4054276
UMLS CUI [1,4]
C0475358
UMLS CUI [1,5]
C3640076
UMLS CUI [1,6]
C0008976
UMLS CUI [1,7]
C0600558
UMLS CUI [1,8]
C0593802
**NCT00084396 - Neoadjuvant Letrozole in Treating Postmenopausal Women With Estrogen-Receptor Positive and/or Progesterone-Receptor Positive Stage II, Stage IIIA, or Stage IIIB Breast Cancer** *Inclusion Criteria* For inclusion in the study, patients must fulfill all of the following criteria:
Description

**NCT00084396 - Neoadjuvant Letrozole in Treating Postmenopausal Women With Estrogen-Receptor Positive and/or Progesterone-Receptor Positive Stage II, Stage IIIA, or Stage IIIB Breast Cancer** *Inclusion Criteria* For inclusion in the study, patients must fulfill all of the following criteria:

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0600558
UMLS CUI [1,3]
C0246421
UMLS CUI [1,4]
C0232970
UMLS CUI [1,5]
C2367479
Palpable and measurable infiltrating adenocarcinoma of the breast confirmed by core needle biopsy, previously untreated, at least T2 (greater than 2cm) by clinical or radiological parameters.
Description

Palpable and measurable infiltrating adenocarcinoma of the breast confirmed by core needle biopsy, previously untreated, at least T2 (greater than 2cm) by clinical or radiological parameters.

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0522499
UMLS CUI [1,3]
C5238366
UMLS CUI [1,4]
C0858252
UMLS CUI [1,5]
C1318309
UMLS CUI [1,6]
C0332155
UMLS CUI [1,7]
C2347201
Stage Clinical T2, T3, T4a, b, c, N0, 1 or 2, M0.
Description

Stage Clinical T2, T3, T4a, b, c, N0, 1 or 2, M0.

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0475373
UMLS CUI [1,3]
C0475374
UMLS CUI [1,4]
C0475395
UMLS CUI [1,5]
C0475396
UMLS CUI [1,6]
C0475397
UMLS CUI [1,7]
C0441959
UMLS CUI [1,8]
C0441962
UMLS CUI [1,9]
C0441960
UMLS CUI [1,10]
C0445034
ER positive and/or PR positive based on 10% or more nuclear staining of the invasive component of the tumor.
Description

ER positive and/or PR positive based on 10% or more nuclear staining of the invasive component of the tumor.

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0279754
UMLS CUI [1,3]
C0279759
UMLS CUI [1,4]
C5237001
UMLS CUI [1,5]
C1300513
Patient is eligible if they would benefit from preoperative therapy with an improvement in surgical outcomes defined as:
Description

Patient is eligible if they would benefit from preoperative therapy with an improvement in surgical outcomes defined as:

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0814225
UMLS CUI [1,3]
C0600558
UMLS CUI [1,4]
C2986411
UMLS CUI [1,5]
C0543467
UMLS CUI [1,6]
C0085415
Marginal candidate for lumpectomy (lumpectomy feasible but patient at risk for positive margins or poor cosmetic outcome. Patient desires breast-conserving surgery if possible.
Description

Marginal candidate for lumpectomy (lumpectomy feasible but patient at risk for positive margins or poor cosmetic outcome. Patient desires breast-conserving surgery if possible.

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0851238
UMLS CUI [1,3]
C0035647
UMLS CUI [1,4]
C1709603
UMLS CUI [1,5]
C0439856
UMLS CUI [1,6]
C0085415
UMLS CUI [1,7]
C1408823
UMLS CUI [2,1]
C1512693
UMLS CUI [2,2]
C0871633
UMLS CUI [2,3]
C0917927
Ineligible for lumpectomy but modified radical mastectomy currently feasible. Patient desires breast-conserving surgery if possible and surgeon judges this would be possible if the primary tumor were smaller.
Description

Ineligible for lumpectomy but modified radical mastectomy currently feasible. Patient desires breast-conserving surgery if possible and surgeon judges this would be possible if the primary tumor were smaller.

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1512714
UMLS CUI [1,3]
C0851238
UMLS CUI [1,4]
C0024883
UMLS CUI [1,5]
C0332149
UMLS CUI [2,1]
C1512693
UMLS CUI [2,2]
C0871633
UMLS CUI [2,3]
C0917927
UMLS CUI [2,4]
C0582175
UMLS CUI [2,5]
C1516048
UMLS CUI [2,6]
C0332149
UMLS CUI [2,7]
C0677930
UMLS CUI [2,8]
C0547044
Inoperable, systemic therapy required for patient to become operableby modified radical mastectomy.
Description

Inoperable, systemic therapy required for patient to become operableby modified radical mastectomy.

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0205187
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C1515119
UMLS CUI [1,5]
C1283255
UMLS CUI [1,6]
C0205188
UMLS CUI [1,7]
C0024883
Written informed consent must be obtained and documented.
Description

Written informed consent must be obtained and documented.

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0811741
In the case of bilateral primaries, both tumors must have features consistent with eligibility criteria.
Description

In the case of bilateral primaries, both tumors must have features consistent with eligibility criteria.

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0238767
UMLS CUI [1,3]
C3846400
UMLS CUI [1,4]
C0332290
UMLS CUI [1,5]
C1516637
Postmenopausal as defined as cessation of menstrual periods for at least one year, bilateral surgical oophorectomy or FSH and estradiol inthe postmenopausal range.
Description

Postmenopausal as defined as cessation of menstrual periods for at least one year, bilateral surgical oophorectomy or FSH and estradiol inthe postmenopausal range.

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0232970
UMLS CUI [1,3]
C1704788
UMLS CUI [1,4]
C0002453
UMLS CUI [1,5]
C3887292
UMLS CUI [2,1]
C1512693
UMLS CUI [2,2]
C0232970
UMLS CUI [2,3]
C1704788
UMLS CUI [2,4]
C0278321
UMLS CUI [3,1]
C1512693
UMLS CUI [3,2]
C0232970
UMLS CUI [3,3]
C1704788
UMLS CUI [3,4]
C0202022
UMLS CUI [3,5]
C0337434
UMLS CUI [3,6]
C1514721
UMLS CUI [3,7]
C0232970
The patient must have an ECOG performance status of 0-2.
Description

The patient must have an ECOG performance status of 0-2.

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C3830346
UMLS CUI [1,3]
C3830345
UMLS CUI [1,4]
C3830344
Patient is willing and able to provide biopsy material for research evaluation.
Description

Patient is willing and able to provide biopsy material for research evaluation.

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0600109
UMLS CUI [1,3]
C1299581
UMLS CUI [1,4]
C1999230
UMLS CUI [1,5]
C0005558
UMLS CUI [1,6]
C0015195
Patient is willing to undergo breast surgery at the end the preoperative treatment period. *Exclusion Criteria* Any of the following is regarded as a criterion for exclusion from the study at the time of enrollment:
Description

Patient is willing to undergo breast surgery at the end the preoperative treatment period. *Exclusion Criteria* Any of the following is regarded as a criterion for exclusion from the study at the time of enrollment:

Data type

boolean

Alias
UMLS CUI [1,1]
C0033061
UMLS CUI [1,2]
C0444930
UMLS CUI [1,3]
C2586066
UMLS CUI [1,4]
C3714726
UMLS CUI [1,5]
C0680251
Inflammatory carcinoma defined as peau d'orange affecting at least one third of the breast. Direct extension of the tumor to skin is not a contraindication.
Description

Inflammatory carcinoma defined as peau d'orange affecting at least one third of the breast. Direct extension of the tumor to skin is not a contraindication.

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0278601
UMLS CUI [1,3]
C1704788
UMLS CUI [1,4]
C0425791
UMLS CUI [2,1]
C3899369
UMLS CUI [2,2]
C1123023
UMLS CUI [2,3]
C1298908
UMLS CUI [2,4]
C1301624
Metastatic breast cancer, excluding isolated ipsilateral superclavicular lymphadenopathy.
Description

Metastatic breast cancer, excluding isolated ipsilateral superclavicular lymphadenopathy.

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0006142
UMLS CUI [1,3]
C2939420
UMLS CUI [1,4]
C2828389
UMLS CUI [1,5]
C0205409
UMLS CUI [1,6]
C0441989
UMLS CUI [1,7]
C0749155
The patient is unwilling to undergo breast surgery at the end the preoperative treatment period.
Description

The patient is unwilling to undergo breast surgery at the end the preoperative treatment period.

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0558080
UMLS CUI [1,3]
C0543467
UMLS CUI [1,4]
C0687676
UMLS CUI [1,5]
C0600558
Any reason that would make the patient unlikely to comply with study requirements (e.g. Confusion, infirmity, alcoholism, etc.)
Description

Any reason that would make the patient unlikely to comply with study requirements (e.g. Confusion, infirmity, alcoholism, etc.)

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0750558
UMLS CUI [1,4]
C0582783
Unwillingness, or inability, to stop taking any drug known to affect sex hormone status (including hormone replacement therapy, phytoestrogenic herbal/alternatives/OTC remedies).
Description

Unwillingness, or inability, to stop taking any drug known to affect sex hormone status (including hormone replacement therapy, phytoestrogenic herbal/alternatives/OTC remedies).

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0558080
UMLS CUI [1,3]
C1299582
UMLS CUI [1,4]
C0850893
UMLS CUI [1,5]
C0521102
UMLS CUI [1,6]
C0301819
Previous history of breast cancer treated with either radiation, chemotherapy, or hormonal agents. Prior history of other invasive malignancies is not an exclusion criteria, unless the disease is active and progressing at the time of protocol screening.
Description

Previous history of breast cancer treated with either radiation, chemotherapy, or hormonal agents. Prior history of other invasive malignancies is not an exclusion criteria, unless the disease is active and progressing at the time of protocol screening.

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0006142
UMLS CUI [1,4]
C0087111
UMLS CUI [1,5]
C0851346
UMLS CUI [1,6]
C3665472
UMLS CUI [1,7]
C0282559
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0006826
UMLS CUI [2,4]
C1298908
UMLS CUI [2,5]
C0680251
UMLS CUI [2,6]
C0332300
UMLS CUI [2,7]
C0205177
UMLS CUI [2,8]
C1947901
Any severe concomitant disease that would preclude surgery or safe administration of the study drug, particularly severe liver dysfunction.
Description

Any severe concomitant disease that would preclude surgery or safe administration of the study drug, particularly severe liver dysfunction.

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0009488
UMLS CUI [1,4]
C0332196
UMLS CUI [1,5]
C0543467
UMLS CUI [1,6]
C3469597
Treatment with a non-approved or experimental drug during the 30 days prior to study initiation.
Description

Treatment with a non-approved or experimental drug during the 30 days prior to study initiation.

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0013230
UMLS CUI [1,4]
C4331910
Prior treatment with an aromatase inhibitor, tamoxifen, raloxifene or other antiestrogen/SERM.
Description

Prior treatment with an aromatase inhibitor, tamoxifen, raloxifene or other antiestrogen/SERM.

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0593802
UMLS CUI [1,4]
C0014930
UMLS CUI [1,5]
C0732611
Concomitant anticancer treatments such as chemotherapy, immunotherapy/biological response modifiers and radiotherapy. Bisphosphonates are allowable if treatment is for osteoporosis.
Description

Concomitant anticancer treatments such as chemotherapy, immunotherapy/biological response modifiers and radiotherapy. Bisphosphonates are allowable if treatment is for osteoporosis.

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1707479
UMLS CUI [1,3]
C3665472
UMLS CUI [1,4]
C0005525
UMLS CUI [1,5]
C1511146
UMLS CUI [1,6]
C1522449
UMLS CUI [2,1]
C1298908
UMLS CUI [2,2]
C0522473
UMLS CUI [2,3]
C0012544
UMLS CUI [2,4]
C4303745
**NCT00265759 - Exemestane, Letrozole, or Anastrozole in Treating Postmenopausal Women Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer** *Inclusion Criteria* For inclusion in the study, patients must fulfill all of the following criteria:
Description

**NCT00265759 - Exemestane, Letrozole, or Anastrozole in Treating Postmenopausal Women Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer** *Inclusion Criteria* For inclusion in the study, patients must fulfill all of the following criteria:

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0851344
UMLS CUI [1,3]
C0246421
UMLS CUI [1,4]
C0290883
UMLS CUI [1,5]
C1522326
UMLS CUI [1,6]
C0232970
UMLS CUI [1,7]
C0543467
UMLS CUI [1,8]
C0278486
UMLS CUI [1,9]
C4721421
Patient must have an ECOG/Zubrod performance status of ≤ 2.
Description

Patient must have an ECOG/Zubrod performance status of ≤ 2.

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C3830346
UMLS CUI [1,3]
C3830345
UMLS CUI [1,4]
C3830344
Patient must have T2-T4c, any N, M0 breast cancer, by clinical staging. NOTE: Primary tumor must be palpable and measure >2 cm by tape, ruler or caliper measurements in at least one dimension.
Description

Patient must have T2-T4c, any N, M0 breast cancer, by clinical staging. NOTE: Primary tumor must be palpable and measure >2 cm by tape, ruler or caliper measurements in at least one dimension.

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C2347201
UMLS CUI [1,3]
C2347202
UMLS CUI [1,4]
C0475751
UMLS CUI [1,5]
C1275865
UMLS CUI [1,6]
C2216705
UMLS CUI [2,1]
C1512693
UMLS CUI [2,2]
C0677930
UMLS CUI [2,3]
C0522499
UMLS CUI [2,4]
C0242485
Patient must be postmenopausal, verified by:
Description

Patient must be postmenopausal, verified by:

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0232970
Patient, as documented by the treating physician, is clinically staged as one of the following:
Description

Patient, as documented by the treating physician, is clinically staged as one of the following:

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0205563
UMLS CUI [1,3]
C0920316
UMLS CUI [1,4]
C1710470
T4 a-c for whom modified radical mastectomy with negative margins is the goal
Description

T4 a-c for whom modified radical mastectomy with negative margins is the goal

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0475751
UMLS CUI [1,3]
C0024883
UMLS CUI [1,4]
C3846230
UMLS CUI [1,5]
C3897977
T2 or T3 for whom conversion from needing mastectomy to breast conservation is the goal
Description

T2 or T3 for whom conversion from needing mastectomy to breast conservation is the goal

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0475373
UMLS CUI [1,3]
C0475374
UMLS CUI [1,4]
C0439836
UMLS CUI [1,5]
C0686904
UMLS CUI [1,6]
C0024881
UMLS CUI [1,7]
C0917927
UMLS CUI [1,8]
C3897977
T2 for whom lumpectomy at first attempt is the goal.
Description

T2 for whom lumpectomy at first attempt is the goal.

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0475373
UMLS CUI [1,3]
C0851238
UMLS CUI [1,4]
C3897977
Patient has an ER+ tumor with an Allred score of 6, 7 or 8. Note: Patients with > 66.6% (two-thirds) of cells staining positive have a minimum Allred score of 6 and are eligible.
Description

Elig.phs000472.v2.p1.34

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C2919519
Patient must have mammogram and ultrasound within 42 days prior to registration.
Description

Patient must have mammogram and ultrasound within 42 days prior to registration.

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0024671
UMLS CUI [1,3]
C0041618
UMLS CUI [1,4]
C0332152
UMLS CUI [1,5]
C1514821
If patient is a cancer survivor, all of the following criteria must be met:
Description

If patient is a cancer survivor, all of the following criteria must be met:

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1516231
UMLS CUI [1,3]
C4329786
Patient has undergone potentially curative therapy for all prior malignancies, ACOSOG Protocol Z1031 Z1031 A7 - 17
Description

Patient has undergone potentially curative therapy for all prior malignancies, ACOSOG Protocol Z1031 Z1031 A7 - 17

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1273390
UMLS CUI [1,3]
C0006826
UMLS CUI [1,4]
C0332152
No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, contralateral DCIS treated with mastectomy or lumpectomy and radiation but without tamoxifen treatment, or non-melanoma skin cancer with no evidence of recurrence), and
Description

No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, contralateral DCIS treated with mastectomy or lumpectomy and radiation but without tamoxifen treatment, or non-melanoma skin cancer with no evidence of recurrence), and

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0332125
UMLS CUI [1,3]
C0006826
UMLS CUI [1,4]
C0332152
UMLS CUI [2,1]
C1532381
UMLS CUI [2,2]
C1705847
UMLS CUI [2,3]
C0087111
UMLS CUI [2,4]
C1272703
UMLS CUI [2,5]
C0851140
UMLS CUI [2,6]
C0279563
UMLS CUI [2,7]
C0441988
UMLS CUI [2,8]
C0007124
UMLS CUI [2,9]
C0024881
UMLS CUI [2,10]
C0740370
UMLS CUI [2,11]
C1522449
UMLS CUI [2,12]
C0746919
UMLS CUI [2,13]
C0039286
UMLS CUI [2,14]
C0699893
UMLS CUI [2,15]
C1298908
UMLS CUI [2,16]
C0025202
Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies *Exclusion Criteria* A patient will NOT be eligible for inclusion in this study if any of the following criteria apply:
Description

Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies *Exclusion Criteria* A patient will NOT be eligible for inclusion in this study if any of the following criteria apply:

Data type

boolean

Alias
UMLS CUI [1,1]
C5201228
UMLS CUI [1,2]
C2986492
UMLS CUI [1,3]
C1516048
UMLS CUI [1,4]
C1710470
UMLS CUI [1,5]
C0920420
UMLS CUI [2,1]
C0680251
Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema).
Description

Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema).

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0278601
UMLS CUI [1,3]
C0041834
UMLS CUI [1,4]
C1708790
UMLS CUI [1,5]
C0425791
Prior treatment for invasive breast cancer, including radiation, endocrine therapy,chemotherapy or investigational agent. Patients whose diagnosis was established by incisional biopsy are not eligible.
Description

Prior treatment for invasive breast cancer, including radiation, endocrine therapy,chemotherapy or investigational agent. Patients whose diagnosis was established by incisional biopsy are not eligible.

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1514463
UMLS CUI [1,3]
C0853879
UMLS CUI [1,4]
C1522449
UMLS CUI [1,5]
C0280229
UMLS CUI [1,6]
C3665472
UMLS CUI [1,7]
C0013230
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C0332139
UMLS CUI [2,3]
C3495404
Patient has received hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration.
Description

Patient has received hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration.

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0282402
UMLS CUI [1,3]
C0065879
UMLS CUI [1,4]
C0244404
UMLS CUI [1,5]
C2987125
Patient has distant metastasis (M1), excluding isolated ipsilateral supraclavicular node involvement.
Description

Patient has distant metastasis (M1), excluding isolated ipsilateral supraclavicular node involvement.

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0441971
UMLS CUI [1,3]
C0332300
UMLS CUI [1,4]
C0205409
UMLS CUI [1,5]
C0441989
UMLS CUI [1,6]
C0686619
UMLS CUI [1,7]
C0229730
Patient does not agree to undergo mastectomy or lumpectomy after neoadjuvant aromatase inhibitor therapy.
Description

Patient does not agree to undergo mastectomy or lumpectomy after neoadjuvant aromatase inhibitor therapy.

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C3873523
UMLS CUI [1,3]
C0024881
UMLS CUI [1,4]
C0851238
UMLS CUI [1,5]
C0687676
UMLS CUI [1,6]
C0600558
UMLS CUI [1,7]
C0593802
Patient is enrolled in another neoadjuvant clinical trial for treatment of the existing breast cancer.
Description

Patient is enrolled in another neoadjuvant clinical trial for treatment of the existing breast cancer.

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C4684790
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C4086621
UMLS CUI [1,5]
C0920425
UMLS CUI [1,6]
C0006142
Cohort B only: Patient has undergone prior sentinel lymph node biopsy.
Description

Cohort B only: Patient has undergone prior sentinel lymph node biopsy.

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0796693
UMLS CUI [1,3]
C0332152
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Similar models

Eligibility Criteria

6 forms
  1. StudyEvent: SEV1
    1. Eligibility Criteria
    2. The subject consent data table contains subject IDs, consent group information, and affection status for estrogen receptor positive (ER+) breast cancer.
    3. The subject sample mapping data table includes a mapping of study subject IDs to sample IDs. Samples are the final preps submitted for genotyping, sequencing, and/or expression data. For example, if one patient (subject ID) gave one sample, and that sample was processed differently to generate 2 sequencing runs, there would be two rows, both using the same subject ID, but having 2 unique sample IDs. The data table also includes sample use.
    4. The subject phenotype data table includes age of enrollment (n=1 variable), tumor pathology (n=10 variables; baseline breast cancer luminal subtype, tumor shape, grade, maximum dimension, number of positive nodes, pathological tumor and node stage, and general comments), PEPI RFS score (n=2 variables), WHO clinical response (n=1 variable) and breast cancer biomarkers (n=15 variables; ER+, Ki-67, and Her2).
    5. The sample attributes data table includes sample type, body site where sample was extracted, sample analyte type, histological type, and time of tumor sample collection.
    6. The pre- and post-subject phenotype data table includes age, sequence of events (n=9 variables; event and recurrence of event, adverse event, follow-up time, survival status, and cause of death), surgical status (n=2 variables), tumor pathology (n=6 variables; baseline tumor type and grade, number of positive nodes, node and tumor stage, and tumor dimension), PEPI RFS score (n=2 variables), and breast cancer biomarkers (n=6 variables; Allred ER+ score and Ki-67).
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion and exclusion criteria
All tumors sequenced were classified as luminal A or B by PAM50 gene expression profiling. Tumor samples for whole genome sequencing were selected from two clinical trials of neoadjuvant aromatase inhibitor therapy:
Item
All tumors sequenced were classified as luminal A or B by PAM50 gene expression profiling. Tumor samples for whole genome sequencing were selected from two clinical trials of neoadjuvant aromatase inhibitor therapy:
boolean
C3642345 (UMLS CUI [1,1])
C3642346 (UMLS CUI [1,2])
C4054276 (UMLS CUI [1,3])
C0475358 (UMLS CUI [1,4])
C3640076 (UMLS CUI [1,5])
C0008976 (UMLS CUI [1,6])
C0600558 (UMLS CUI [1,7])
C0593802 (UMLS CUI [1,8])
**NCT00084396 - Neoadjuvant Letrozole in Treating Postmenopausal Women With Estrogen-Receptor Positive and/or Progesterone-Receptor Positive Stage II, Stage IIIA, or Stage IIIB Breast Cancer** *Inclusion Criteria* For inclusion in the study, patients must fulfill all of the following criteria:
Item
**NCT00084396 - Neoadjuvant Letrozole in Treating Postmenopausal Women With Estrogen-Receptor Positive and/or Progesterone-Receptor Positive Stage II, Stage IIIA, or Stage IIIB Breast Cancer** *Inclusion Criteria* For inclusion in the study, patients must fulfill all of the following criteria:
boolean
C1512693 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0246421 (UMLS CUI [1,3])
C0232970 (UMLS CUI [1,4])
C2367479 (UMLS CUI [1,5])
Palpable and measurable infiltrating adenocarcinoma of the breast confirmed by core needle biopsy, previously untreated, at least T2 (greater than 2cm) by clinical or radiological parameters.
Item
Palpable and measurable infiltrating adenocarcinoma of the breast confirmed by core needle biopsy, previously untreated, at least T2 (greater than 2cm) by clinical or radiological parameters.
boolean
C1512693 (UMLS CUI [1,1])
C0522499 (UMLS CUI [1,2])
C5238366 (UMLS CUI [1,3])
C0858252 (UMLS CUI [1,4])
C1318309 (UMLS CUI [1,5])
C0332155 (UMLS CUI [1,6])
C2347201 (UMLS CUI [1,7])
Stage Clinical T2, T3, T4a, b, c, N0, 1 or 2, M0.
Item
Stage Clinical T2, T3, T4a, b, c, N0, 1 or 2, M0.
boolean
C1512693 (UMLS CUI [1,1])
C0475373 (UMLS CUI [1,2])
C0475374 (UMLS CUI [1,3])
C0475395 (UMLS CUI [1,4])
C0475396 (UMLS CUI [1,5])
C0475397 (UMLS CUI [1,6])
C0441959 (UMLS CUI [1,7])
C0441962 (UMLS CUI [1,8])
C0441960 (UMLS CUI [1,9])
C0445034 (UMLS CUI [1,10])
ER positive and/or PR positive based on 10% or more nuclear staining of the invasive component of the tumor.
Item
ER positive and/or PR positive based on 10% or more nuclear staining of the invasive component of the tumor.
boolean
C1512693 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C0279759 (UMLS CUI [1,3])
C5237001 (UMLS CUI [1,4])
C1300513 (UMLS CUI [1,5])
Patient is eligible if they would benefit from preoperative therapy with an improvement in surgical outcomes defined as:
Item
Patient is eligible if they would benefit from preoperative therapy with an improvement in surgical outcomes defined as:
boolean
C1512693 (UMLS CUI [1,1])
C0814225 (UMLS CUI [1,2])
C0600558 (UMLS CUI [1,3])
C2986411 (UMLS CUI [1,4])
C0543467 (UMLS CUI [1,5])
C0085415 (UMLS CUI [1,6])
Marginal candidate for lumpectomy (lumpectomy feasible but patient at risk for positive margins or poor cosmetic outcome. Patient desires breast-conserving surgery if possible.
Item
Marginal candidate for lumpectomy (lumpectomy feasible but patient at risk for positive margins or poor cosmetic outcome. Patient desires breast-conserving surgery if possible.
boolean
C1512693 (UMLS CUI [1,1])
C0851238 (UMLS CUI [1,2])
C0035647 (UMLS CUI [1,3])
C1709603 (UMLS CUI [1,4])
C0439856 (UMLS CUI [1,5])
C0085415 (UMLS CUI [1,6])
C1408823 (UMLS CUI [1,7])
C1512693 (UMLS CUI [2,1])
C0871633 (UMLS CUI [2,2])
C0917927 (UMLS CUI [2,3])
Ineligible for lumpectomy but modified radical mastectomy currently feasible. Patient desires breast-conserving surgery if possible and surgeon judges this would be possible if the primary tumor were smaller.
Item
Ineligible for lumpectomy but modified radical mastectomy currently feasible. Patient desires breast-conserving surgery if possible and surgeon judges this would be possible if the primary tumor were smaller.
boolean
C1512693 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
C0851238 (UMLS CUI [1,3])
C0024883 (UMLS CUI [1,4])
C0332149 (UMLS CUI [1,5])
C1512693 (UMLS CUI [2,1])
C0871633 (UMLS CUI [2,2])
C0917927 (UMLS CUI [2,3])
C0582175 (UMLS CUI [2,4])
C1516048 (UMLS CUI [2,5])
C0332149 (UMLS CUI [2,6])
C0677930 (UMLS CUI [2,7])
C0547044 (UMLS CUI [2,8])
Inoperable, systemic therapy required for patient to become operableby modified radical mastectomy.
Item
Inoperable, systemic therapy required for patient to become operableby modified radical mastectomy.
boolean
C1512693 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C1515119 (UMLS CUI [1,4])
C1283255 (UMLS CUI [1,5])
C0205188 (UMLS CUI [1,6])
C0024883 (UMLS CUI [1,7])
Written informed consent must be obtained and documented.
Item
Written informed consent must be obtained and documented.
boolean
C1512693 (UMLS CUI [1,1])
C0811741 (UMLS CUI [1,2])
In the case of bilateral primaries, both tumors must have features consistent with eligibility criteria.
Item
In the case of bilateral primaries, both tumors must have features consistent with eligibility criteria.
boolean
C1512693 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
C3846400 (UMLS CUI [1,3])
C0332290 (UMLS CUI [1,4])
C1516637 (UMLS CUI [1,5])
Postmenopausal as defined as cessation of menstrual periods for at least one year, bilateral surgical oophorectomy or FSH and estradiol inthe postmenopausal range.
Item
Postmenopausal as defined as cessation of menstrual periods for at least one year, bilateral surgical oophorectomy or FSH and estradiol inthe postmenopausal range.
boolean
C1512693 (UMLS CUI [1,1])
C0232970 (UMLS CUI [1,2])
C1704788 (UMLS CUI [1,3])
C0002453 (UMLS CUI [1,4])
C3887292 (UMLS CUI [1,5])
C1512693 (UMLS CUI [2,1])
C0232970 (UMLS CUI [2,2])
C1704788 (UMLS CUI [2,3])
C0278321 (UMLS CUI [2,4])
C1512693 (UMLS CUI [3,1])
C0232970 (UMLS CUI [3,2])
C1704788 (UMLS CUI [3,3])
C0202022 (UMLS CUI [3,4])
C0337434 (UMLS CUI [3,5])
C1514721 (UMLS CUI [3,6])
C0232970 (UMLS CUI [3,7])
The patient must have an ECOG performance status of 0-2.
Item
The patient must have an ECOG performance status of 0-2.
boolean
C1512693 (UMLS CUI [1,1])
C3830346 (UMLS CUI [1,2])
C3830345 (UMLS CUI [1,3])
C3830344 (UMLS CUI [1,4])
Patient is willing and able to provide biopsy material for research evaluation.
Item
Patient is willing and able to provide biopsy material for research evaluation.
boolean
C1512693 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C1299581 (UMLS CUI [1,3])
C1999230 (UMLS CUI [1,4])
C0005558 (UMLS CUI [1,5])
C0015195 (UMLS CUI [1,6])
Patient is willing to undergo breast surgery at the end the preoperative treatment period. *Exclusion Criteria* Any of the following is regarded as a criterion for exclusion from the study at the time of enrollment:
Item
Patient is willing to undergo breast surgery at the end the preoperative treatment period. *Exclusion Criteria* Any of the following is regarded as a criterion for exclusion from the study at the time of enrollment:
boolean
C0033061 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
C2586066 (UMLS CUI [1,3])
C3714726 (UMLS CUI [1,4])
C0680251 (UMLS CUI [1,5])
Inflammatory carcinoma defined as peau d'orange affecting at least one third of the breast. Direct extension of the tumor to skin is not a contraindication.
Item
Inflammatory carcinoma defined as peau d'orange affecting at least one third of the breast. Direct extension of the tumor to skin is not a contraindication.
boolean
C0680251 (UMLS CUI [1,1])
C0278601 (UMLS CUI [1,2])
C1704788 (UMLS CUI [1,3])
C0425791 (UMLS CUI [1,4])
C3899369 (UMLS CUI [2,1])
C1123023 (UMLS CUI [2,2])
C1298908 (UMLS CUI [2,3])
C1301624 (UMLS CUI [2,4])
Metastatic breast cancer, excluding isolated ipsilateral superclavicular lymphadenopathy.
Item
Metastatic breast cancer, excluding isolated ipsilateral superclavicular lymphadenopathy.
boolean
C0680251 (UMLS CUI [1,1])
C0006142 (UMLS CUI [1,2])
C2939420 (UMLS CUI [1,3])
C2828389 (UMLS CUI [1,4])
C0205409 (UMLS CUI [1,5])
C0441989 (UMLS CUI [1,6])
C0749155 (UMLS CUI [1,7])
The patient is unwilling to undergo breast surgery at the end the preoperative treatment period.
Item
The patient is unwilling to undergo breast surgery at the end the preoperative treatment period.
boolean
C0680251 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
C0600558 (UMLS CUI [1,5])
Any reason that would make the patient unlikely to comply with study requirements (e.g. Confusion, infirmity, alcoholism, etc.)
Item
Any reason that would make the patient unlikely to comply with study requirements (e.g. Confusion, infirmity, alcoholism, etc.)
boolean
C0680251 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0750558 (UMLS CUI [1,3])
C0582783 (UMLS CUI [1,4])
Unwillingness, or inability, to stop taking any drug known to affect sex hormone status (including hormone replacement therapy, phytoestrogenic herbal/alternatives/OTC remedies).
Item
Unwillingness, or inability, to stop taking any drug known to affect sex hormone status (including hormone replacement therapy, phytoestrogenic herbal/alternatives/OTC remedies).
boolean
C0680251 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0850893 (UMLS CUI [1,4])
C0521102 (UMLS CUI [1,5])
C0301819 (UMLS CUI [1,6])
Previous history of breast cancer treated with either radiation, chemotherapy, or hormonal agents. Prior history of other invasive malignancies is not an exclusion criteria, unless the disease is active and progressing at the time of protocol screening.
Item
Previous history of breast cancer treated with either radiation, chemotherapy, or hormonal agents. Prior history of other invasive malignancies is not an exclusion criteria, unless the disease is active and progressing at the time of protocol screening.
boolean
C0680251 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0006142 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0851346 (UMLS CUI [1,5])
C3665472 (UMLS CUI [1,6])
C0282559 (UMLS CUI [1,7])
C0262926 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
C1298908 (UMLS CUI [2,4])
C0680251 (UMLS CUI [2,5])
C0332300 (UMLS CUI [2,6])
C0205177 (UMLS CUI [2,7])
C1947901 (UMLS CUI [2,8])
Any severe concomitant disease that would preclude surgery or safe administration of the study drug, particularly severe liver dysfunction.
Item
Any severe concomitant disease that would preclude surgery or safe administration of the study drug, particularly severe liver dysfunction.
boolean
C0680251 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0332196 (UMLS CUI [1,4])
C0543467 (UMLS CUI [1,5])
C3469597 (UMLS CUI [1,6])
Treatment with a non-approved or experimental drug during the 30 days prior to study initiation.
Item
Treatment with a non-approved or experimental drug during the 30 days prior to study initiation.
boolean
C0680251 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C4331910 (UMLS CUI [1,4])
Prior treatment with an aromatase inhibitor, tamoxifen, raloxifene or other antiestrogen/SERM.
Item
Prior treatment with an aromatase inhibitor, tamoxifen, raloxifene or other antiestrogen/SERM.
boolean
C0680251 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0593802 (UMLS CUI [1,3])
C0014930 (UMLS CUI [1,4])
C0732611 (UMLS CUI [1,5])
Concomitant anticancer treatments such as chemotherapy, immunotherapy/biological response modifiers and radiotherapy. Bisphosphonates are allowable if treatment is for osteoporosis.
Item
Concomitant anticancer treatments such as chemotherapy, immunotherapy/biological response modifiers and radiotherapy. Bisphosphonates are allowable if treatment is for osteoporosis.
boolean
C0680251 (UMLS CUI [1,1])
C1707479 (UMLS CUI [1,2])
C3665472 (UMLS CUI [1,3])
C0005525 (UMLS CUI [1,4])
C1511146 (UMLS CUI [1,5])
C1522449 (UMLS CUI [1,6])
C1298908 (UMLS CUI [2,1])
C0522473 (UMLS CUI [2,2])
C0012544 (UMLS CUI [2,3])
C4303745 (UMLS CUI [2,4])
**NCT00265759 - Exemestane, Letrozole, or Anastrozole in Treating Postmenopausal Women Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer** *Inclusion Criteria* For inclusion in the study, patients must fulfill all of the following criteria:
Item
**NCT00265759 - Exemestane, Letrozole, or Anastrozole in Treating Postmenopausal Women Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer** *Inclusion Criteria* For inclusion in the study, patients must fulfill all of the following criteria:
boolean
C1512693 (UMLS CUI [1,1])
C0851344 (UMLS CUI [1,2])
C0246421 (UMLS CUI [1,3])
C0290883 (UMLS CUI [1,4])
C1522326 (UMLS CUI [1,5])
C0232970 (UMLS CUI [1,6])
C0543467 (UMLS CUI [1,7])
C0278486 (UMLS CUI [1,8])
C4721421 (UMLS CUI [1,9])
Patient must have an ECOG/Zubrod performance status of ≤ 2.
Item
Patient must have an ECOG/Zubrod performance status of ≤ 2.
boolean
C1512693 (UMLS CUI [1,1])
C3830346 (UMLS CUI [1,2])
C3830345 (UMLS CUI [1,3])
C3830344 (UMLS CUI [1,4])
Patient must have T2-T4c, any N, M0 breast cancer, by clinical staging. NOTE: Primary tumor must be palpable and measure >2 cm by tape, ruler or caliper measurements in at least one dimension.
Item
Patient must have T2-T4c, any N, M0 breast cancer, by clinical staging. NOTE: Primary tumor must be palpable and measure >2 cm by tape, ruler or caliper measurements in at least one dimension.
boolean
C1512693 (UMLS CUI [1,1])
C2347201 (UMLS CUI [1,2])
C2347202 (UMLS CUI [1,3])
C0475751 (UMLS CUI [1,4])
C1275865 (UMLS CUI [1,5])
C2216705 (UMLS CUI [1,6])
C1512693 (UMLS CUI [2,1])
C0677930 (UMLS CUI [2,2])
C0522499 (UMLS CUI [2,3])
C0242485 (UMLS CUI [2,4])
Patient must be postmenopausal, verified by:
Item
Patient must be postmenopausal, verified by:
boolean
C1512693 (UMLS CUI [1,1])
C0232970 (UMLS CUI [1,2])
Patient, as documented by the treating physician, is clinically staged as one of the following:
Item
Patient, as documented by the treating physician, is clinically staged as one of the following:
boolean
C1512693 (UMLS CUI [1,1])
C0205563 (UMLS CUI [1,2])
C0920316 (UMLS CUI [1,3])
C1710470 (UMLS CUI [1,4])
T4 a-c for whom modified radical mastectomy with negative margins is the goal
Item
T4 a-c for whom modified radical mastectomy with negative margins is the goal
boolean
C1512693 (UMLS CUI [1,1])
C0475751 (UMLS CUI [1,2])
C0024883 (UMLS CUI [1,3])
C3846230 (UMLS CUI [1,4])
C3897977 (UMLS CUI [1,5])
T2 or T3 for whom conversion from needing mastectomy to breast conservation is the goal
Item
T2 or T3 for whom conversion from needing mastectomy to breast conservation is the goal
boolean
C1512693 (UMLS CUI [1,1])
C0475373 (UMLS CUI [1,2])
C0475374 (UMLS CUI [1,3])
C0439836 (UMLS CUI [1,4])
C0686904 (UMLS CUI [1,5])
C0024881 (UMLS CUI [1,6])
C0917927 (UMLS CUI [1,7])
C3897977 (UMLS CUI [1,8])
T2 for whom lumpectomy at first attempt is the goal.
Item
T2 for whom lumpectomy at first attempt is the goal.
boolean
C1512693 (UMLS CUI [1,1])
C0475373 (UMLS CUI [1,2])
C0851238 (UMLS CUI [1,3])
C3897977 (UMLS CUI [1,4])
Elig.phs000472.v2.p1.34
Item
Patient has an ER+ tumor with an Allred score of 6, 7 or 8. Note: Patients with > 66.6% (two-thirds) of cells staining positive have a minimum Allred score of 6 and are eligible.
boolean
C1512693 (UMLS CUI [1,1])
C2919519 (UMLS CUI [1,2])
Patient must have mammogram and ultrasound within 42 days prior to registration.
Item
Patient must have mammogram and ultrasound within 42 days prior to registration.
boolean
C1512693 (UMLS CUI [1,1])
C0024671 (UMLS CUI [1,2])
C0041618 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C1514821 (UMLS CUI [1,5])
If patient is a cancer survivor, all of the following criteria must be met:
Item
If patient is a cancer survivor, all of the following criteria must be met:
boolean
C1512693 (UMLS CUI [1,1])
C1516231 (UMLS CUI [1,2])
C4329786 (UMLS CUI [1,3])
Patient has undergone potentially curative therapy for all prior malignancies, ACOSOG Protocol Z1031 Z1031 A7 - 17
Item
Patient has undergone potentially curative therapy for all prior malignancies, ACOSOG Protocol Z1031 Z1031 A7 - 17
boolean
C1512693 (UMLS CUI [1,1])
C1273390 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, contralateral DCIS treated with mastectomy or lumpectomy and radiation but without tamoxifen treatment, or non-melanoma skin cancer with no evidence of recurrence), and
Item
No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, contralateral DCIS treated with mastectomy or lumpectomy and radiation but without tamoxifen treatment, or non-melanoma skin cancer with no evidence of recurrence), and
boolean
C1512693 (UMLS CUI [1,1])
C0332125 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C1532381 (UMLS CUI [2,1])
C1705847 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C1272703 (UMLS CUI [2,4])
C0851140 (UMLS CUI [2,5])
C0279563 (UMLS CUI [2,6])
C0441988 (UMLS CUI [2,7])
C0007124 (UMLS CUI [2,8])
C0024881 (UMLS CUI [2,9])
C0740370 (UMLS CUI [2,10])
C1522449 (UMLS CUI [2,11])
C0746919 (UMLS CUI [2,12])
C0039286 (UMLS CUI [2,13])
C0699893 (UMLS CUI [2,14])
C1298908 (UMLS CUI [2,15])
C0025202 (UMLS CUI [2,16])
Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies *Exclusion Criteria* A patient will NOT be eligible for inclusion in this study if any of the following criteria apply:
Item
Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies *Exclusion Criteria* A patient will NOT be eligible for inclusion in this study if any of the following criteria apply:
boolean
C5201228 (UMLS CUI [1,1])
C2986492 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C1710470 (UMLS CUI [1,4])
C0920420 (UMLS CUI [1,5])
C0680251 (UMLS CUI [2,1])
Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema).
Item
Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema).
boolean
C0680251 (UMLS CUI [1,1])
C0278601 (UMLS CUI [1,2])
C0041834 (UMLS CUI [1,3])
C1708790 (UMLS CUI [1,4])
C0425791 (UMLS CUI [1,5])
Prior treatment for invasive breast cancer, including radiation, endocrine therapy,chemotherapy or investigational agent. Patients whose diagnosis was established by incisional biopsy are not eligible.
Item
Prior treatment for invasive breast cancer, including radiation, endocrine therapy,chemotherapy or investigational agent. Patients whose diagnosis was established by incisional biopsy are not eligible.
boolean
C0680251 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0853879 (UMLS CUI [1,3])
C1522449 (UMLS CUI [1,4])
C0280229 (UMLS CUI [1,5])
C3665472 (UMLS CUI [1,6])
C0013230 (UMLS CUI [1,7])
C0680251 (UMLS CUI [2,1])
C0332139 (UMLS CUI [2,2])
C3495404 (UMLS CUI [2,3])
Patient has received hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration.
Item
Patient has received hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration.
boolean
C0680251 (UMLS CUI [1,1])
C0282402 (UMLS CUI [1,2])
C0065879 (UMLS CUI [1,3])
C0244404 (UMLS CUI [1,4])
C2987125 (UMLS CUI [1,5])
Patient has distant metastasis (M1), excluding isolated ipsilateral supraclavicular node involvement.
Item
Patient has distant metastasis (M1), excluding isolated ipsilateral supraclavicular node involvement.
boolean
C0680251 (UMLS CUI [1,1])
C0441971 (UMLS CUI [1,2])
C0332300 (UMLS CUI [1,3])
C0205409 (UMLS CUI [1,4])
C0441989 (UMLS CUI [1,5])
C0686619 (UMLS CUI [1,6])
C0229730 (UMLS CUI [1,7])
Patient does not agree to undergo mastectomy or lumpectomy after neoadjuvant aromatase inhibitor therapy.
Item
Patient does not agree to undergo mastectomy or lumpectomy after neoadjuvant aromatase inhibitor therapy.
boolean
C0680251 (UMLS CUI [1,1])
C3873523 (UMLS CUI [1,2])
C0024881 (UMLS CUI [1,3])
C0851238 (UMLS CUI [1,4])
C0687676 (UMLS CUI [1,5])
C0600558 (UMLS CUI [1,6])
C0593802 (UMLS CUI [1,7])
Patient is enrolled in another neoadjuvant clinical trial for treatment of the existing breast cancer.
Item
Patient is enrolled in another neoadjuvant clinical trial for treatment of the existing breast cancer.
boolean
C0680251 (UMLS CUI [1,1])
C4684790 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C4086621 (UMLS CUI [1,4])
C0920425 (UMLS CUI [1,5])
C0006142 (UMLS CUI [1,6])
Cohort B only: Patient has undergone prior sentinel lymph node biopsy.
Item
Cohort B only: Patient has undergone prior sentinel lymph node biopsy.
boolean
C0680251 (UMLS CUI [1,1])
C0796693 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
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