Phase 2 Study of Pembrolizumab+Carboplatin in Breast Related Cancer Antigens-related Metastatic Breast Cancer (PEMBRACA)

Summary

This is a prospective two-stage single arm phase II study to be conducted in conformance with Good Clinical Practices. This study will enrol 53 patients, based on a two steps Simon's design. Patients will entry into the study if the following conditions will be satisfied: * BRCA1/2 germline mutations. * Metastatic disease with measurable lesions will be evaluated by computed tomography or by PET (Positron Emission Tomography) scan. * Patients must have received anthracycline and taxanes before entry into the study. Patients will be treated with Carboplatin AUC6 (Area Under The Curve) EV (endovenous) every 3 weeks in combination with Pembrolizumab 200 mg EV every 3 weeks for 6 cycles. Afterwards, the Pembrolizumab will recontinued with the same schedule until unacceptable toxicity or disease progression. The primary endpoint will be Objective Responses Rate (ORR) (complete answers + partial answers) evaluated according to the RECIST criteria.

Timeline

Start

2018-12-12

Primary completion

2022-06-30

Completion

2023-01-30

Drugs

Indications