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A Study of Pembrolizumab With Carboplatin and Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer

NCT02755272 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2025-07-04

No results posted yet for this study

Summary

The main purpose of this study is to see if Pembrolizumab in combination with chemotherapy (carboplatin and gemcitabine) is safe and effective in treating patients with metastatic triple negative breast cancer.

Pembrolizumab is a drug which may help the immune system to target and destroy cancer cells. Pembrolizumab has been approved by the FDA for the treatment of advanced melanoma and metastatic non-small cell lung cancer. However, it has not been approved as a treatment for breast cancer.

Conditions

  • Carcinoma Breast Stage IV

Interventions

DRUG

Pembrolizumab

IV Infusion of 200 mg given on day one of each 21 day treatment cycle.

DRUG

Carboplatin

IV infusion of a calculated dose (AUC 2 mL/min) given on days one and eight of each 21 day treatment cycle.

DRUG

Gemcitabine

IV infusion of 800 mg/m\^2 given on days one and eight of each 21 day treatment cycle.

Sponsors & Collaborators

  • University of Wisconsin, Madison

    collaborator OTHER

  • Fox Chase Cancer Center

    lead OTHER

Principal Investigators

  • Elias Obeid, MD · Fox Chase Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02755272 on ClinicalTrials.gov