Ph II Study of Pembrolizumab & Eribulin in Patients With HR+/HER2- MBC Previously Treated With Anthracyclines & Taxanes

Summary

This a multicenter, open-label, phase II clinical trial to assess the efficacy of pembrolizumab in combination with eribulin in female patients older than 18 years old with hormone receptor-(HR)positive/HER2-negative metastatic breast cancer (MBC) previously treated with at least one, but not more than two, prior chemotherapeutic regimens for treatment of locally recurrent and/or metastatic disease. Prior therapy must have included an anthracycline and a taxane and prior anti-hormonal therapy is mandatory. The number of patients to be included is 44 patients at 11 sites. All eligible patients will be treated with MK3475 (pembrolizumab) 200 mg on day 1 of each 21-day cycle and eribulin 1.23 mg/m2 (equivalent to eribulin mesylate at 1.4 mg/m2) on days 1 and 8 of every 21-day cycle.

Timeline

Start

2017-12-14

Primary completion

2018-10-31

Completion

2020-12-23

Publications

• Perez-Garcia JM, Llombart-Cussac A, G Cortes M, Curigliano G, Lopez-Miranda E, Alonso JL, Bermejo B, Calvo L, Caranana V, de la Cruz Sanchez S, M Vazquez R, Prat A, R Borrego M, Sampayo-Cordero M, Segui-Palmer MA, Soberino J, Malfettone A, Schmid P, Cortes J. Pembrolizumab plus eribulin in hormone-receptor-positive, HER2-negative, locally recurrent or metastatic breast cancer (KELLY): An open-label, multicentre, single-arm, phase Ⅱ trial. Eur J Cancer. 2021 May;148:382-394. doi: 10.1016/j.ejca.2021.02.028. Epub 2021 Mar 29.

Drugs

Indications