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Effect of Pembrolizumab and Cisplatin on Metastatic, Locally Recurrent or Inoperable Triple-Negative Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:
A Phase II Trial Evaluating Safety and Efficacy of Pembrolizumab and Cisplatin in Patients With Advanced Triple Negative Breast Cancer

Clinical Trial Summary

This is a Phase II treatment study that is done to evaluate how effective and safe the combination of pembrolizumab and cisplatin work in treating participants with triple-negative breast cancer that had spread to other parts of the body, has come back, or cannot be removed by surgery. Pembrolizumab (investigational drug) is a monoclonal antibody that works by helping your immune system to fight cancer. Cisplatin is a chemotherapy drug that works by interfering with tumor cell division. Studies also suggest that treatment with chemotherapy, like cisplatin, may improve the effectiveness of pembrolizumab. This study will test the effectiveness of pembrolizumab and cisplatin in participants with advanced triple-negative breast cancer.

Clinical Trial Description

Participants will receive pembrolizumab intravenously (IV) over 30 minutes and cisplatin once every 3 weeks for a total of 6 doses. Both drugs are given by vein (Intravenous(IV)) on day 1. Participants that are responding to the study treatment will continue to receive pembrolizumab alone for up to 24 months until disease gets worse, having bad side effects, no longer wish to be in the study, or have become pregnant (whichever comes first).

In addition to study drug administration visits, participants will be asked to have physical exams, blood draws every three weeks and tumor evaluation using MRI or CT scans every 9 weeks.

After completion of study treatment, participants are followed up for safety within at 30 days of last dose of study treatment and then every 12 weeks until study completion. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03644589
Study type Interventional
Source University of Washington
Contact
Status Withdrawn
Phase Phase 2
Start date April 1, 2019
Completion date October 30, 2022
View Details
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