RecruitingPhase 2NCT03213041

Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells Positive Metastatic Breast Cancer

I-CURE-1: A Phase II, Single Arm Study of Pembroluzimab Combined With Carboplatin in Patients With Circulating Tumor Cells (CTCs) Positive Her-2 Negative Metastatic Breast Cancer (MBC)


Sponsor

Northwestern University

Enrollment

100 participants

Start Date

Sep 14, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of the study is to evaluate the impact on progression-free survival (PFS) with the combination carboplatin - pembrolizumab in patients with CTC (circulating tumor cells) positive, HER2 negative metastatic breast cancer previously treated with anthracyclines and taxanes. Previous studies have indicated that recurrent breast cancers are more resistant to chemotherapy and maybe associated with a weak immune system. This study is investigating the use of an immune therapy drug, pembrolizumab, that has the ability to restore the capacity of controlling and killing cancer cells of an important component of your immune system called T-cells. Pembrolizumab has been found effective in other types of cancer and has already been approved by FDA for those indications, but the efficacy in breast cancer is still unknown. In this study, pembrolizumab will be combined with chemotherapy to increase the cancer cell killing. There is no control or placebo treatment in this study.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing the combination of pembrolizumab (an immunotherapy drug) and carboplatin (a chemotherapy drug) for patients with metastatic breast cancer whose cancer cells have been detected in the blood (called circulating tumor cells, or CTCs). **You may be eligible if...** - You have metastatic triple-negative breast cancer (the cancer is negative for estrogen, progesterone, and HER2 receptors) and have not yet had chemotherapy for metastatic disease - OR you have HER2-negative metastatic breast cancer with detectable cancer cells in your blood (circulating tumor cells) - You have not previously received chemotherapy for metastatic disease **You may NOT be eligible if...** - Your breast cancer is HER2-positive - You have already received chemotherapy for metastatic disease - You do not have detectable circulating tumor cells (for the non-triple-negative group) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCarboplatin

Given IV

OTHERLaboratory Biomarker Analysis

Correlative studies

BIOLOGICALPembrolizumab

Given IV


Locations(1)

Northwestern University

Chicago, Illinois, United States

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NCT03213041


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