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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
BRE12-158: A Postneoadjuvant, Randomized Phase II Trial of Personalized Therapy Versus Treatment of Physician’s Choice for Patients With Residual Triple-Negative Breast Cancer
Journal of Clinical Oncology, Volume 40, No. 4, Year 2022
Notification
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Description
PURPOSE Patients with triple-negative breast cancer (TNBC) with residual disease after neoadjuvant chemotherapy (NAC) have high risk of recurrence with prior data suggesting improved outcomes with capecitabine. Targeted agents have demonstrated activity across multiple cancer types. BRE12-158 was a phase II, multicenter trial that randomly allocated patients with TNBC with residual disease after NAC to genomically directed therapy versus treatment of physician choice (TPC). PATIENTS AND METHODS From March 2014 to December 2018, 193 patients were enrolled. Residual tumors were sequenced using a next-generation sequencing test. A molecular tumor board adjudicated all results. Patients were randomly allocated to four cycles of genomically directed therapy (arm A) versus TPC (arm B). Patients without a target were assigned to arm B. Primary end point was 2-year disease-free survival (DFS) among randomly assigned patients. Secondary/exploratory end points included distant disease-free survival, overall survival, toxicity assessment, time-based evolution of therapy, and drug-specific outcomes. RESULTS One hundred ninety-three patients were randomly allocated or were assigned to arm B. The estimated 2-year DFS for the randomized population only was 56.6% (95% CI, 0.45 to 0.70) for arm A versus 62.4% (95% CI, 0.52 to 0.75) for arm B. No difference was seen in DFS, distant disease-free survival, or overall survival for the entire or randomized populations. There was increased uptake of capecitabine for TPC over time. Patients randomly allocated later had less distant recurrences. Circulating tumor DNA status remained a significant predictor of outcome with some patients demonstrating clearance with postneoadjuvant therapy. CONCLUSION Genomically directed therapy was not superior to TPC for patients with residual TNBC after NAC. Capecitabine should remain the standard of care; however, the activity of other agents in this setting provides rationale for testing optimal combinations to improve outcomes. Circulating tumor DNA should be considered a standard covariate for trials in this setting. © 2021 by American Society of Clinical Oncology.
Authors & Co-Authors
Ballinger, Tarah Jean
United States, Indianapolis
Indiana University-purdue University Indianapolis
Falkson, Carla Isadora
United States, Birmingham
The University of Alabama at Birmingham
Gallagher, Christopher M.
United States, Washington, D.c.
Georgetown University
Isaacs, Claudine J.
United States, Washington, D.c.
Georgetown University
Thompson, Michael A.
United States, Milwaukee
Advocate Aurora Health
BADVE, Sunil S.
United States, Indianapolis
Indiana University-purdue University Indianapolis
Radovich, Milan
United States, Indianapolis
Indiana University-purdue University Indianapolis
Statistics
Citations: 16
Authors: 7
Affiliations: 12
Identifiers
Doi:
10.1200/JCO.21.01657
ISSN:
0732183X
Research Areas
Cancer
Genetics And Genomics
Study Design
Cross Sectional Study
Exploratory Study