Standard of Care Chemotherapy Plus Pembrolizumab for Breast Cancer
NCT02734290 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2026-04-24
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.
Conditions
Interventions
- DRUG
-
Pembrolizumab 200mg every 3 weeks by IV infusion on Day 1 of each 3 week cycle
- DRUG
-
Paclitaxel 80mg/m2 every 3 weeks by IV infusion on Days 1, 8, and 15 of each 3 week cycle
- DRUG
-
Capecitabine 2000mg every two weeks by mouth twice each day on days 1-7 of each 2 week cycle.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Providence Health & Services
lead OTHER
Principal Investigators
-
David Page, MD · Medical Oncologist
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-02-23
- Primary Completion
- 2019-08-21
- Completion
- 2026-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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