Study on Pembrolizumab and Carboplatin for Treating Metastatic Breast Cancer with Circulating Tumor Cells

Sponsor: Northwestern University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03213041

Provider View

This clinical trial is exploring the combination of pembrolizumab, an immune therapy drug, and carboplatin, a chemotherapy drug, to see if they can improve outcomes for patients with metastatic breast cancer that is HER2 negative and has circulating tumor cells. The study aims to determine if this combination can help control cancer growth and improve survival rates.

Patient Parameters

Program Overview

The purpose of this study is to find out if combining pembrolizumab, an immune therapy drug, with carboplatin, a chemotherapy drug, can help control the growth of metastatic breast cancer that is HER2 negative and has circulating tumor cells (CTCs). Pembrolizumab works by boosting the immune system's ability to fight cancer cells. This study will not use a placebo, meaning all participants will receive the actual treatment. Researchers hope to see if this combination can improve progression-free survival, which is the length of time during and after treatment that a patient lives with the disease without it getting worse.

Description

The main goal of this study is to see if the combination of pembrolizumab and carboplatin can help patients with metastatic breast cancer live longer without their cancer getting worse. Researchers will also look at overall survival rates, which is the length of time patients live after starting the treatment, and how well the cancer responds to the treatment. They will also study how the immune system responds to the treatment and how long it takes for new metastases to appear.

Participants will receive pembrolizumab through an IV on the first day of each treatment cycle, and carboplatin will be added starting from the third cycle. Each cycle lasts 21 days, and the treatment will continue for up to 24 months unless the cancer progresses or side effects become too severe.

After finishing the treatment, participants will have follow-up visits within 30 days, every 9 weeks for the first year, and then every 12 weeks to monitor their health and the effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have metastatic breast cancer that is hormone receptor negative and HER2 negative (triple negative breast cancer) and have not received chemotherapy for metastatic disease.
  • Have circulating tumor cells (CTCs) of 5 or more.
  • Have measurable disease based on specific criteria.
  • Be willing to provide a sample of previous tumor tissue if available.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have adequate organ function as shown by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective contraception during the study and for 120 days after the last dose.
  • Men must agree to use effective contraception during the study and for 120 days after the last dose.
  • Be willing to provide written informed consent to participate in the study.

Exclusion Criteria

  • Have HER2-positive breast cancer.
  • Are currently participating in another study or have used an investigational drug or device within 28 days before starting this study.
  • Have an immune deficiency or are taking immunosuppressive drugs within 7 days before starting the study.
  • Have a history of active tuberculosis.
  • Are allergic to pembrolizumab or its ingredients.
  • Have received certain cancer treatments within 4 weeks before starting the study and have not recovered from side effects.
  • Have another cancer that has progressed or required treatment in the last 5 years, except for certain skin cancers or in situ cervical cancer.
  • Have active brain metastases or cancer in the brain lining.
  • Have an active autoimmune disease requiring treatment in the past 2 years.
  • Have active, non-infectious lung inflammation or a history of severe lung inflammation.
  • Have an active infection requiring treatment.
  • Have a condition or history that might interfere with the study or is not in the best interest of the participant.
  • Are pregnant or breastfeeding, or planning to conceive or father a child during the study and for 120 days after the last dose.
  • Have received prior therapy with certain immune checkpoint inhibitors.
  • Have a known history of HIV or active hepatitis B or C.
  • Have received a live vaccine within 30 days before starting the study.

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