A Randomized Phase II Study of Pembrolizumab an anti-PD (programmed cell death)-1 Antibody in Combination with Carboplatin Compared to Carboplatin Alone in Breast Cancer Patients with Chest Wall Disease

Study on the Effects of an Investigational Medication and Chemotherapy on Breast Cancer

Recruiting
18 years - 100 years
All
Phase N/A
1 Location

Brief description of study.

This study is being done to see what effects the combination of pembrolizumab and carboplatin have on breast cancer compared to carboplatin alone.

Detailed description of study

The primary objective is to determine the disease control rate (including CR, PR and stable disease as defined by RECIST 1.1 at 18 weeks of treatment in breast cancer patients with chest wall disease treated with pembrolizumab and carboplatin or carboplatin alone.
Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: breast cancer
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria

In order to be eligible to take part in this trial, patients must meet the following criteria:

  • Advanced breast cancer with locally recurrent chest wall disease not amenable to surgical excision.
  • At least two weeks from last systemic therapy for breast cancer, with recovery of all treatment related toxicity to grade 1 or less. Subjects with ≤ Grade 2 neuropathy are an exception to this criterion.

For a full list of participation criteria, please visit clinicaltrials.gov.

Updated on 19 Feb 2024. Study ID: 1802063021 (TBCRC044)

This study investigates the effects of combining an investigational medication with carboplatin, a chemotherapy drug, on breast cancer. It compares this combination to using carboplatin alone. The main goal is to see how well the cancer is controlled in patients with chest wall disease after 18 weeks of treatment. Chest wall disease refers to cancer that has spread to the chest wall, which is the area around the ribs, muscles, and skin.

Participants in the study will receive either the combination of the investigational medication and carboplatin or carboplatin alone. The study will measure the disease control rate, including complete response, partial response, and stable disease, as defined by RECIST 1.1. RECIST 1.1 is a set of rules used to measure how cancer responds to treatment.

  • Who can participate: Adults with advanced breast cancer that has returned in the chest wall and cannot be removed by surgery can participate. Participants must have completed their last systemic therapy at least two weeks prior and have recovered from treatment-related side effects to a mild level, except for mild neuropathy.
  • Study details: Participants will receive either a combination of the investigational medication and carboplatin or carboplatin alone. A placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine, will not be used in this study.
  • Study Timelines: The study will last 18 weeks.

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