We are happy to inform you that we have achieved the 75% of recruitment of the KELLY study!
This a multicenter, open-label, phase II clinical trial to assess the efficacy of pembrolizumab in combination with eribulin in female patients 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 in the metastatic disease setting is mandatory.
11 Spanish sites are participating in this study and the number of patients to be included is 44. Recruitment started in February 2018 and there are currently 33 patients included (23 patients are ongoing now) and 3 patients in screening.
This study also includes the sub-study CALADRIO (approved in May 2018), with the interest to characterize the microbiome as a potential predictive factor of response to anti-PD-1 immunotherapy pembrolizumab in patients with the KELLY indication. Since May 2018, buccal and fecal microbiome samples have been collected for 18 patients.
From the MedSIR team, we would like to thank all the study teams for their implication and effort identifying patients that can benefit from their participation. In special, we would like to thank for their commitment and for being the top recruiters to Hospital Clínico de Valencia (Dr Begoña Bermejo), Hospital Ramón y Cajal (Dr María Gion), Hospital Quironsalud de Barcelona (Dr José Pérez) and MD Anderson (Dr Raúl Márquez). Another special thanks is for MSD and Eisai for their continuous support. We are confident to reach the end of recruitment in October 2018, as initially planned.