NCT02734290

Standard of Care Chemotherapy Plus Pembrolizumab for Breast Cancer

A Pilot and Phase II Study to Assess the Safety, Tolerability and Efficacy of Pembrolizumab Plus Chemotherapy in Metastatic Triple Negative Breast Cancer Patients

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Providence Health & Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab 200mg every 3 weeks by IV infusion on Day 1 of each 3 week cycle
DRUG	Paclitaxel	Paclitaxel 80mg/m2 every 3 weeks by IV infusion on Days 1, 8, and 15 of each 3 week cycle
DRUG	Capecitabine	Capecitabine 2000mg every two weeks by mouth twice each day on days 1-7 of each 2 week cycle.

Timeline

• Start date: 2016-02-23
• Primary completion: 2019-08-21
• Completion: 2025-12-01
• First posted: 2016-04-12
• Last updated: 2025-03-10
• Results posted: 2024-02-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study