# BRE12-158 (Hoosier Oncology Group)

Source: https://onco.cc/trials/bre12-158/  
OnCo record `bre12-158` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

BRE12-158 sequenced the cancer left behind after pre-operative chemotherapy and matched a targeted drug to it. Matched therapy was no better than the doctor's usual choice, which increasingly meant capecitabine, and blood-borne tumour DNA after surgery predicted who relapsed.

## Summary

BRE12-158 (NCT02101385) enrolled 193 patients with triple-negative breast cancer and residual disease after neoadjuvant chemotherapy between March 2014 and December 2018; residual tumours were sequenced, a molecular tumour board adjudicated results, and patients with a target were randomised to four cycles of genomically directed monotherapy (arm A) or treatment of physician's choice (arm B), with patients lacking a target assigned to arm B. Two-year disease-free survival in the randomised population was 56.6 percent (95 percent confidence interval 45 to 70) for genomically directed therapy against 62.4 percent (52 to 75) for physician's choice, with no difference in disease-free, distant disease-free or overall survival. Capecitabine uptake in the control arm rose over time and later-randomised patients had fewer distant recurrences. Circulating tumour DNA status after surgery remained a significant predictor of outcome, with clearance in some patients on post-neoadjuvant therapy; the authors concluded that capecitabine should remain the standard and that ctDNA should be a standard covariate in post-neoadjuvant trials.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-24
- Also known as: BRE12-158; HCRN BRE12-158
- Registry id: NCT02101385
- Phase: 2
- Setting: Triple-negative breast cancer with residual disease after neoadjuvant chemotherapy: four cycles of genomically directed therapy chosen by a molecular tumour board versus treatment of physician's choice, United States
- Sponsor: Bryan Schneider, Indiana University / Hoosier Cancer Research Network
- Enrolled: 193
- Result: 2-year DFS 56.6% (genomically directed) vs 62.4% (physician's choice); no difference in DFS, DDFS or OS. Post-surgical ctDNA predicted outcome.
- Outcomes: Disease-free survival at 2 years (randomised population): Genomically directed therapy 56.6% vs Treatment of physician's choice 62.4%
- Replication: The ctDNA finding is echoed by c-TRAK TN (UK) and underpins the ctDNA-guided post-neoadjuvant trials now recruiting.

## Sources

- ClinicalTrials.gov NCT02101385: https://clinicaltrials.gov/study/NCT02101385
- Radovich, Schneider et al., JCO 2022: BRE12-158 personalized therapy versus treatment of physician's choice for residual TNBC: https://doi.org/10.1200/JCO.21.01657

## Connected records

- cancers: [Early triple-negative breast cancer](https://onco.cc/cancers/tnbc-early/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [MRD / molecular residual disease testing](https://onco.cc/technologies/mrd-testing/)
- drugs: [Capecitabine](https://onco.cc/drugs/capecitabine/)
- terms: [Circulating tumour DNA (ctDNA)](https://onco.cc/terms/ctdna/), [Event-free / disease-free survival (EFS, DFS, iDFS, RFS)](https://onco.cc/terms/efs/), [Residual cancer burden (RCB)](https://onco.cc/terms/rcb/), [Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point](https://onco.cc/terms/tnbc-residual-disease-decision/)
- trials: [c-TRAK TN](https://onco.cc/trials/c-trak-tn/), [CREATE-X](https://onco.cc/trials/create-x/), [ECOG-ACRIN EA1131](https://onco.cc/trials/ea1131/), [Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease](https://onco.cc/trials/nct04915755/)

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