Official Title: A multicenter, randomized, phase II trial evaluating the efficacy of eribulin monotherapy and eribulin plus endocrine therapy in locally-recurrent or metastatic breast cancer patients after progression on endocrine therapy (REVERT). Code: MedOPP167
The primary endpoint is the overall response rate in the arm corresponding to the patients treated with eribulin in combination with aromatase inhibitor therapy based on local investigator’s assessment according to RECIST v.1.1
REVERT is a Simon’s two-stage admissible design clinical trial, 60 patients will be included, 22 in stage I and 38 in stage II.
Patients will receive eribulin injections intravenously on days 1 and 8 of every 21- day cycle, alone or in combination with endocrine therapy (aromatase inhibitor).
REVERT at clinicaltrials.gov