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

Metastatic Breast Cancer Clinical Trial

Official title:
A Phase II Study of Pembrolizumab Plus Carboplatin in BRCA-related Metastatic Breast Cancer

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03732391
Study type Interventional
Source Azienda Ospedaliero-Universitaria di Modena
Contact
Status Completed
Phase Phase 2
Start date December 12, 2018
Completion date January 30, 2023
View Details
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