ID

45633

Description

Principal Investigator: Elaine R. Mardis, PhD, Nationwide Children's Hospital, Columbus, OH, USA MeSH: Breast Neoplasms https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001291 HER2 (ERBB2) gene amplification and overexpression are present in 15-30% of invasive breast cancers. While HER2-targeted agents such as trastuzumab are effective treatments, therapeutic resistance remains a concern in HER2-positive breast cancer with 40-50% of patients having residual disease after neoadjuvant treatment with chemotherapy and trastuzumab. To investigate features that may make it possible to predict at diagnosis which cancers will be responsive to trastuzumab and chemotherapy, 48 tumor/normal DNA pairs extracted from pretreatment tumor biopsies and blood of HER2-positive breast cancer cases treated with neoadjuvant chemotherapy and trastuzumab were sequenced. Whole genome and exome sequence from tumor (average depth 49x and 71x) and normal (average depth 33x and 69x) DNA are included here as well as RNAseq data for 42 of the tumors. The study cohort was equally divided between patients who experienced pathological complete response and those with residual disease. Samples were obtained from the American College of Surgeons Oncology Group Z1041 trial (NCT00513292) and a local single-institution study (NCT00353483).

Link

dbGaP study = phs001291

Keywords

Versions (1)
  1. 3/9/23 3/9/23 - Simon Heim
Copyright Holder

Elaine R. Mardis, PhD, Nationwide Children's Hospital, Columbus, OH, USA

Uploaded on

March 9, 2023

DOI

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License

Creative Commons BY 4.0
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dbGaP phs001291 Neoadjuvant Trastuzumab Response in Breast Cancer

English

Eligibility Criteria

5 forms  
Inclusion and exclusion criteria
Description

Inclusion and exclusion criteria

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
Case selection: 37 cases were accessed from the American College of Surgeons Oncology Group Z1041 trial (NCT00513292) that compared the pathological complete response (pCR) rate of patients with HER2-positive breast cancer who received a sequential regimen of concurrent weekly paclitaxel and trastuzumab followed by continued weekly trastuzumab administered concurrently with fluorouracil, epirubicin, and cyclophosphamide (FEC-75) to the pCR rate of a sequential regimen of FEC-75 alone followed by concurrent weekly paclitaxel and trastuzumab. An additional 11 HER2-positive included breast cancer cases were enrolled in a local trial at Washington University School of Medicine (NCT00353483) and received neoadjuvant treatment with trastuzumab in combination with other chemotherapies. All cases were females with invasive breast cancer, not pregnant, and >= 18 years of age. All cases were identified as HER2-positive by IHC and/or FISH.
Description

Case selection: 37 cases were accessed from the American College of Surgeons Oncology Group Z1041 trial (NCT00513292) that compared the pathological complete response (pCR) rate of patients with HER2-positive breast cancer who received a sequential regimen of concurrent weekly paclitaxel and trastuzumab followed by continued weekly trastuzumab administered concurrently with fluorouracil, epirubicin, and cyclophosphamide (FEC-75) to the pCR rate of a sequential regimen of FEC-75 alone followed by concurrent weekly paclitaxel and trastuzumab. An additional 11 HER2-positive included breast cancer cases were enrolled in a local trial at Washington University School of Medicine (NCT00353483) and received neoadjuvant treatment with trastuzumab in combination with other chemotherapies. All cases were females with invasive breast cancer, not pregnant, and >= 18 years of age. All cases were identified as HER2-positive by IHC and/or FISH.

Data type

boolean

Alias
UMLS CUI [1,1]
C3669352
UMLS CUI [1,2]
C0030761
UMLS CUI [1,3]
C1706256
UMLS CUI [1,4]
C1515944
UMLS CUI [1,5]
C1579762
UMLS CUI [1,6]
C4054230
UMLS CUI [1,7]
C1960398
UMLS CUI [1,8]
C0087111
UMLS CUI [1,9]
C4522185
UMLS CUI [1,10]
C0728747
UMLS CUI [1,11]
C0060133
UMLS CUI [1,12]
C4050242
UMLS CUI [1,13]
C0020028
UMLS CUI [1,14]
C1516879
UMLS CUI [1,15]
C0600558
UMLS CUI [1,16]
C1521750
UMLS CUI [1,17]
C0086287
UMLS CUI [1,18]
C0853879
UMLS CUI [1,19]
C0232973
UMLS CUI [1,20]
C0001779
UMLS CUI [1,21]
C0021044
UMLS CUI [1,22]
C0162789
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Similar models

Eligibility Criteria

5 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion and exclusion criteria
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Case selection: 37 cases were accessed from the American College of Surgeons Oncology Group Z1041 trial (NCT00513292) that compared the pathological complete response (pCR) rate of patients with HER2-positive breast cancer who received a sequential regimen of concurrent weekly paclitaxel and trastuzumab followed by continued weekly trastuzumab administered concurrently with fluorouracil, epirubicin, and cyclophosphamide (FEC-75) to the pCR rate of a sequential regimen of FEC-75 alone followed by concurrent weekly paclitaxel and trastuzumab. An additional 11 HER2-positive included breast cancer cases were enrolled in a local trial at Washington University School of Medicine (NCT00353483) and received neoadjuvant treatment with trastuzumab in combination with other chemotherapies. All cases were females with invasive breast cancer, not pregnant, and >= 18 years of age. All cases were identified as HER2-positive by IHC and/or FISH.
Item
Case selection: 37 cases were accessed from the American College of Surgeons Oncology Group Z1041 trial (NCT00513292) that compared the pathological complete response (pCR) rate of patients with HER2-positive breast cancer who received a sequential regimen of concurrent weekly paclitaxel and trastuzumab followed by continued weekly trastuzumab administered concurrently with fluorouracil, epirubicin, and cyclophosphamide (FEC-75) to the pCR rate of a sequential regimen of FEC-75 alone followed by concurrent weekly paclitaxel and trastuzumab. An additional 11 HER2-positive included breast cancer cases were enrolled in a local trial at Washington University School of Medicine (NCT00353483) and received neoadjuvant treatment with trastuzumab in combination with other chemotherapies. All cases were females with invasive breast cancer, not pregnant, and >= 18 years of age. All cases were identified as HER2-positive by IHC and/or FISH.
boolean
C3669352 (UMLS CUI [1,1])
C0030761 (UMLS CUI [1,2])
C1706256 (UMLS CUI [1,3])
C1515944 (UMLS CUI [1,4])
C1579762 (UMLS CUI [1,5])
C4054230 (UMLS CUI [1,6])
C1960398 (UMLS CUI [1,7])
C0087111 (UMLS CUI [1,8])
C4522185 (UMLS CUI [1,9])
C0728747 (UMLS CUI [1,10])
C0060133 (UMLS CUI [1,11])
C4050242 (UMLS CUI [1,12])
C0020028 (UMLS CUI [1,13])
C1516879 (UMLS CUI [1,14])
C0600558 (UMLS CUI [1,15])
C1521750 (UMLS CUI [1,16])
C0086287 (UMLS CUI [1,17])
C0853879 (UMLS CUI [1,18])
C0232973 (UMLS CUI [1,19])
C0001779 (UMLS CUI [1,20])
C0021044 (UMLS CUI [1,21])
C0162789 (UMLS CUI [1,22])
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