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

Conditions

• Carcinoma Breast Stage IV

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pembrolizumab — DRUG
  IV Infusion of 200 mg given on day one of each 21 day treatment cycle.
• Carboplatin — DRUG
  IV infusion of a calculated dose (AUC 2 mL/min) given on days one and eight of each 21 day treatment cycle.
• Gemcitabine — DRUG
  IV infusion of 800 mg/m\^2 given on days one and eight of each 21 day treatment cycle.

Study Details

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.

Key Dates

Start date

May 31, 2016

Status verified

Jul 2025

Primary completion

May 31, 2026

Completion

May 31, 2026

Study Design

Enrollment

87 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Pembrolizumab with Standard Chemotherapy
  Pembrolizumab plus standard chemotherapy using carboplatin and gemcitabine.
• Active Comparator: Standard Chemotherapy Alone
  Standard chemotherapy alone using carboplatin and gemcitabine.

Primary Outcome Measure

Objective Response Rate [ Time Frame: Up to 24 months ]

Locations (6)

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