Standard of Care Chemotherapy Plus Pembrolizumab for Breast Cancer

Status Active, not recruiting

Clinical Trial Summary

The goal of this study is to establish the safety and tolerability of pembrolizumab when administered in combination with either of two chemotherapy regimens (weekly paclitaxel or capecitabine) in unresectable/metastatic triple negative breast cancer (MTNBC) patients.

Clinical Trial Description

In the pilot phase, patients will be enrolled to one of two experimental arms, which will be selected by the treating investigator (arm A: pembrolizumab + weekly paclitaxel; arm B: pembrolizumab + capecitabine). Subjects will receive pembrolizumab via intravenous (IV) infusion at 200mg every three weeks (Q3W), and continue treatment Q3W until progression of disease, initiation of alternative cancer therapy, unacceptable toxicity, or other reasons to discontinue treatment occur, up to 24 months. Paclitaxel will be administered intervenously on a weekly schedule at a dose of 80mg/m2. Oral capecitabine will be administered at total daily dose of 4,000 mg (2,000 mg two times each day (abbreviated BID)). Capecitabine will be administered as intermittent therapy given on days 1-7 in 14-day cycles. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02734290
Study type	Interventional
Source	Providence Health & Services
Contact
Status	Active, not recruiting
Phase	Phase 1/Phase 2
Start date	February 23, 2016
Completion date	December 2025

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See also
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