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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 and older
All
Phase N/A

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.
Study details
    breast cancer

TX8819

19 February 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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