A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Capecitabine in Patients with Residual Triple-Negative Breast Cancer following Neoadjuvant Chemotherapy

On 3/19/21, the ECOG-ACRIN DSMC determined that, based on the invasive disease-free survival events observed in both EA1131 arms thus far, the study is unlikely to show that a platinum drug is either superior or non-inferior to capecitabine. Additionally, more grade 3 and 4 toxicities were seen in the platinum arm. Therefore, EA1131 was permanently closed to accrual, effective 3/30/21.

Treating physicians must discuss the DSMB findings with participants enrolled in EA1131. See the associated physician and patient notification letters posted at www.ctsu.org.

Participants currently receiving protocol therapy on Arm C (capecitabine arm) should continue treatment. Participants currently receiving protocol therapy on Arm B (platinum arm), after discussion of risks and benefits, including potential for greater toxicity, may choose to stop platinum treatment and switch to post-neoadjuvant capecitabine if the participants and their physicians believe this is an appropriate medical intervention for the participant. Note: There is no guidance on the optimal duration of capecitabine following a few cycles of post-neoadjuvant platinum. Alternatively, participants and physicians may continue the participants’ protocol-specified therapy with a platinum, if they believe that is an appropriate
medical intervention.

Required testing, biospecimen collection, PRO questionnaires, long-term follow-up and data submission will continue for all randomized participants according to protocol, unless a study participant declines to remain on study.

SWOG activated: 7/24/19