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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.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
193 enrolled.
95 percent confidence interval 45 to 70 · 95 percent confidence interval 52 to 75
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Disease-free survival at 2 years (randomised population)primary | Genomically directed therapy | - | 56.6% | - | - | link |
| Treatment of physician's choice | - | 62.4% |
Shares CREATE-X, Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point, Event-free / disease-free survival (EFS, DFS, iDFS, RFS), Capecitabine.
Shares CREATE-X, Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point, Event-free / disease-free survival (EFS, DFS, iDFS, RFS), Capecitabine.
Shares CREATE-X, Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point, Residual cancer burden (RCB), Event-free / disease-free survival (EFS, DFS, iDFS, RFS).
Shares CREATE-X, Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point, Residual cancer burden (RCB), Event-free / disease-free survival (EFS, DFS, iDFS, RFS).
Shares Residual cancer burden (RCB), Circulating tumour DNA (ctDNA), MRD / molecular residual disease testing, Early triple-negative breast cancer.
Shares Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point, Residual cancer burden (RCB), Event-free / disease-free survival (EFS, DFS, iDFS, RFS), Early triple-negative breast cancer.
Shares Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point, Residual cancer burden (RCB), Circulating tumour DNA (ctDNA), Early triple-negative breast cancer.
Shares Residual cancer burden (RCB), Event-free / disease-free survival (EFS, DFS, iDFS, RFS), Early triple-negative breast cancer, Triple-negative breast cancer (TNBC).