TBCRC 031: Randomized Phase II Study of Neoadjuvant Cisplatin Versus Doxorubicin-Cyclophosphamide in Germline BRCA Carriers With HER2-Negative Breast Cancer (the INFORM trial)
Author(s) -
Nadine Tung,
Banu K. Arun,
Michele R. Hacker,
Erin Hofstatter,
Deborah Toppmeyer,
Steven J. Isakoff,
Virginia F. Borges,
Robert D. Legare,
Claudine Isaacs,
Antonio C. Wolff,
P. Kelly Marcom,
Erica L. Mayer,
Paulina Lange,
Andrew J. Goss,
C. David Jenkins,
Ian E. Krop,
Eric P. Winer,
Stuart J. Schnitt,
Judy E. Garber
Publication year - 2020
Publication title -
journal of clinical oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 10.482
H-Index - 548
eISSN - 1527-7755
pISSN - 0732-183X
DOI - 10.1200/jco.19.03292
Subject(s) - medicine , breast cancer , cyclophosphamide , oncology , brca mutation , triple negative breast cancer , cancer , chemotherapy , doxorubicin
Platinum compounds have activity in triple-negative breast cancer (TNBC) in germline BRCA mutation carriers ( BRCA carriers). Limited data exist for estrogen receptor (ER)-positive (+) breast cancer among BRCA carriers. INFORM is a randomized, multicenter, phase II trial comparing pathologic complete response (pCR) rates (ypT0/is, N0) after neoadjuvant single-agent cisplatin (CDDP) versus doxorubicin-cyclophosphamide (AC) in BRCA carriers with stage I-III human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Secondary objectives included residual cancer burden scores (RCB) of 0 or 1 (combined) and toxicity. The goal was to determine whether pCR was ≥ 20% higher with CDDP than AC.
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