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ID
45612
Beschreibung
Principal Investigator: James N. Ingle, MD, Mayo Clinic, Rochester, MN, USA MeSH: Breast Neoplasms https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001365 Neoadjuvant chemotherapy (NAC) for breast cancer is widely employed. We performed genome-wide association studies (GWAS) to determine if germline genetic variability was associated with benefits, in terms of pathological complete response (pCR), disease-free survival (DFS), and overall survival (OS), in patients entered on the NSABP B-40 NAC (National Surgical Adjuvant Breast and Bowel Project, B-40, Neoadjuvant Chemotherapy) trial where some patients were randomized to receive bevacizumab, in addition to chemotherapy.
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- 22.02.23 22.02.23 - Chiara Middel
Rechteinhaber
James N. Ingle, MD, Mayo Clinic, Rochester, MN, USA
Hochgeladen am
22. Februar 2023
DOI
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Creative Commons BY 4.0
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dbGaP phs001365 Neoadjuvant Chemotherapy +/- Bevacizumab Pharmacogenomics
Eligibility Criteria
- StudyEvent: SEV1
- Eligibility Criteria
- The subject consent file includes subject IDs, consent information, and case control status of the subject for pathologic complete response (pCR) .
- This data table contains 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.
- This subject phenotype table contains subject ID, tumor size, nodal status, hormone receptor status, gemcitabine treatment, capecitabine treatment, bevacizumab treatment, age at randomization, estrogen receptor status, progesterone receptor status, race, histologic tumor grade, side of cancer, completion of neoadjuvant therapies by protocol, best response status, time to last follow-up in years, censoring code for death, time to the first disease-free survival (DFS) event, and censoring code for TOFF (time to the first DFS event).
- This sample attributes table contains sample ID, body site where sample was collected, analyte type, tumor status, histological type, and name of the center which conducted genotyping.
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Eligibility Criteria
- StudyEvent: SEV1
- Eligibility Criteria
- The subject consent file includes subject IDs, consent information, and case control status of the subject for pathologic complete response (pCR) .
- This data table contains 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.
- This subject phenotype table contains subject ID, tumor size, nodal status, hormone receptor status, gemcitabine treatment, capecitabine treatment, bevacizumab treatment, age at randomization, estrogen receptor status, progesterone receptor status, race, histologic tumor grade, side of cancer, completion of neoadjuvant therapies by protocol, best response status, time to last follow-up in years, censoring code for death, time to the first disease-free survival (DFS) event, and censoring code for TOFF (time to the first DFS event).
- This sample attributes table contains sample ID, body site where sample was collected, analyte type, tumor status, histological type, and name of the center which conducted genotyping.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion and exclusion criteria
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0680251 (UMLS CUI [1,2])
Elig.phs001365.v1.p1.1
Item
Patients were randomized to one of three chemotherapy regimens, and one-half of the patients also randomized to receive bevacizumab, based on reports of efficacy in the advanced disease setting. The three regimens were
boolean
C0034656 (UMLS CUI [1,1])
C0205449 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C0796392 (UMLS CUI [1,4])
C0205449 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C0796392 (UMLS CUI [1,4])
Elig.phs001365.v1.p1.2
Item
four cycles of docetaxel followed by four cycles of doxorubicin plus cyclophosphamide,
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,3])
C0246415 (UMLS CUI [1,4])
C0013089 (UMLS CUI [1,5])
C0010583 (UMLS CUI [1,6])
C1265611 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,3])
C0246415 (UMLS CUI [1,4])
C0013089 (UMLS CUI [1,5])
C0010583 (UMLS CUI [1,6])
Elig.phs001365.v1.p1.3
Item
same as regimen 1, except for the addition of capecitabine to docetaxel, and
boolean
C0392920 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0671970 (UMLS CUI [1,3])
C1524062 (UMLS CUI [1,2])
C0671970 (UMLS CUI [1,3])
Elig.phs001365.v1.p1.4
Item
same as regimen 1, except for the addition of gemcitabine to docetaxel. Patients were stratified according to age at entry (<49 or >50 years old), clinical tumor size (2.0 to 4 cm or >4.1 cm), and hormone receptor status (estrogen receptor [ER] positive, progesterone receptor [PgR] positive, or both vs. ER and PgR negative). Eligibility criteria for NSABP B-40 included primary operable breast cancer which was diagnosed with a core needle biopsy with a palpable primary tumor at least 2.0 cm in diameter, HER2-negative, and TMN stages T1c to T3, N0 to N2a, and M0. All patients on current study provided blood samples for DNA extraction and consent for genetic testing.
boolean
C0392920 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0045093 (UMLS CUI [1,3])
C1514983 (UMLS CUI [2,1])
C0001779 (UMLS CUI [2,2])
C0475440 (UMLS CUI [2,3])
C0019929 (UMLS CUI [2,4])
C0449438 (UMLS CUI [2,5])
C1516637 (UMLS CUI [3,1])
C0205188 (UMLS CUI [3,2])
C0678222 (UMLS CUI [3,3])
C0475440 (UMLS CUI [3,4])
C2348908 (UMLS CUI [3,5])
C3258246 (UMLS CUI [3,6])
C0005834 (UMLS CUI [4,1])
C0012854 (UMLS CUI [4,2])
C0185115 (UMLS CUI [4,3])
C0021430 (UMLS CUI [4,4])
C0679560 (UMLS CUI [4,5])
C1524062 (UMLS CUI [1,2])
C0045093 (UMLS CUI [1,3])
C1514983 (UMLS CUI [2,1])
C0001779 (UMLS CUI [2,2])
C0475440 (UMLS CUI [2,3])
C0019929 (UMLS CUI [2,4])
C0449438 (UMLS CUI [2,5])
C1516637 (UMLS CUI [3,1])
C0205188 (UMLS CUI [3,2])
C0678222 (UMLS CUI [3,3])
C0475440 (UMLS CUI [3,4])
C2348908 (UMLS CUI [3,5])
C3258246 (UMLS CUI [3,6])
C0005834 (UMLS CUI [4,1])
C0012854 (UMLS CUI [4,2])
C0185115 (UMLS CUI [4,3])
C0021430 (UMLS CUI [4,4])
C0679560 (UMLS CUI [4,5])