Welcome to the first patient in REVERT study. This is 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.
The primary endpoint is the overall response rate (ORR) in the arm corresponding to the patients treated with eribulin in combination with aromatase inhibitor therapy (eribulin+ET arm), defined as the proportion of patients with best overall response of confirmed complete response or partial response based on local investigator’s assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.
On this study the eligible patients will be pre- and post-menopausal women with unresectable, ER-positive and/or PR-positive and HER2-negative locally-recurrent or metastatic breast cancer (mBC) with no prior line of chemotherapy in the metastatic setting and that has shown progression while on an aromatase inhibitor-containing regimen in the metastatic setting or within six months from last aromatase inhibitor dose in the adjuvant setting.
Hospital Ramón y Cajal (Madrid) has been enrolled the first patient, who started to receive the study treatment last June 24, 2019. The inclusion of this first patient is just the beginning of the next 15 months of enrollment in order to achieve the number of 60 patients randomized (22 in stage I and 38 in stage II) in 9 Spanish sites.
We highly appreciate the whole investigator team’s involvement especially in the set-up procedure of REVERT study.
Author: Noemí López