# ECOG-ACRIN EA1131

Source: https://onco.cc/trials/ea1131/  
OnCo record `ea1131` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-24
- Also known as: EA1131
- Registry id: NCT02445391
- Phase: 3
- Setting: Stage II to III triple-negative breast cancer with residual invasive disease of 1 cm or more after neoadjuvant chemotherapy: adjuvant platinum (carboplatin or cisplatin, four cycles) versus capecitabine (six cycles), United States and South Africa
- Sponsor: ECOG-ACRIN Cancer Research Group / National Cancer Institute
- Enrolled: 415
- Result: Closed for futility: platinum not superior or non-inferior to capecitabine for iDFS in basal-like residual TNBC (primary hazard ratio not indexed).
- Replication: Consistent with CREATE-X's role for capecitabine; no trial has since tested platinum after residual disease.

## Sources

- ClinicalTrials.gov NCT02445391: https://clinicaltrials.gov/study/NCT02445391
- EA1131 patient-reported outcomes (Cancer 2024): https://doi.org/10.1002/cncr.35187
- EA1131: race, socioeconomic status and outcomes (JCO Oncology Advances 2026): https://doi.org/10.1200/OA-25-00177

## 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: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Platinum agents](https://onco.cc/technologies/platinum/)
- drugs: [Capecitabine](https://onco.cc/drugs/capecitabine/), [Carboplatin](https://onco.cc/drugs/carboplatin/), [Cisplatin](https://onco.cc/drugs/cisplatin/)
- companies: [ECOG-ACRIN Cancer Research Group](https://onco.cc/companies/ecog-acrin/)
- institutions: [National Cancer Institute (NIH)](https://onco.cc/institutions/nci/)
- terms: [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: [BRE12-158 (Hoosier Oncology Group)](https://onco.cc/trials/bre12-158/), [CREATE-X](https://onco.cc/trials/create-x/), [KEYNOTE-522](https://onco.cc/trials/keynote-522/)

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