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EA1131 asked whether platinum chemotherapy after surgery beats capecitabine for triple-negative breast cancer that survived pre-operative chemotherapy. It was stopped early because platinum was not going to prove better and was more toxic, so capecitabine stayed the standard.
ECOG-ACRIN EA1131 (NCT02445391) randomised 415 patients with stage II to III triple-negative breast cancer and residual invasive disease of at least 1 cm after neoadjuvant chemotherapy to four cycles of carboplatin or cisplatin or six cycles of capecitabine; the primary endpoint was three-year invasive disease-free survival in basal-like tumours (77 percent of enrolled patients by PAM50). The trial was closed early after a prespecified futility analysis found platinum unlikely to be superior or non-inferior to capecitabine (JCO 2021; the primary paper is not indexed on Europe PMC, so its hazard ratio is not quoted here). Patient-reported outcomes (Cancer 2024, 296 patients) showed a greater on-treatment symptom burden with capecitabine at cycle 3 despite a similar frequency of clinician-rated adverse events, and a clinically meaningful decline in neurotoxicity scores on platinum. A 2026 post hoc analysis (376 patients, 18 percent Black) found no racial difference in disease-free or overall survival despite worse socioeconomic indices among Black patients. EA1131 keeps capecitabine (CREATE-X) as the non-BRCA post-neoadjuvant standard and is the reason platinum is not offered in that setting.
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.
415 enrolled.
95% CI 30.5 to 53.1; Figures from the ClinicalTrials.gov results section (first posted 2022-10-05), not from a publication · 95% CI 39.0 to 59.0
Source95% CI 45.2 to 68.4; Figures from the ClinicalTrials.gov results section (first posted 2022-10-05), not from a publication · 95% CI 56.3 to 74.3
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| 3-year Invasive Disease-Free Survival (IDFS) Rate in Basal-Subtype Patientsprimary | Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open) | 148 | 42% | 1.06 (0.62 to 1.81) | - | link |
| Arm C (Capecitabine) (Open to Accrual 6/22/2016) | 160 | 49.4% | ||||
| 3-year Overall Survival (OS) Rate in Basal-Subtype Patients | Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open) | 148 | 57.8% | - | - | link |
| Arm C (Capecitabine) (Open to Accrual 6/22/2016) | 160 | 66.2% |
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), Early triple-negative breast cancer.
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), Early triple-negative breast cancer.
Shares Residual cancer burden (RCB), Event-free / disease-free survival (EFS, DFS, iDFS, RFS), KEYNOTE-522, 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), KEYNOTE-522.
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 BRE12-158 (Hoosier Oncology Group), Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point, Residual cancer burden (RCB), KEYNOTE-522.
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), KEYNOTE-522, Early triple-negative breast cancer, Platinum agents.