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

Study results available
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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

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.

Sponsors & Collaborators

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02734290 on ClinicalTrials.gov