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Study of Pembrolizumab and Carboplatin for Patients with BRCA-Related Metastatic Breast Cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of breast cancer known as BRCA-related metastatic breast cancer. The study is investigating the effects of a treatment that combines two medications: Pembrolizumab and Carboplatin. Pembrolizumab, also known by its code name MK-3475, is a medication that helps the immune system fight cancer cells. Carboplatin is a chemotherapy drug that works by stopping the growth of cancer cells.

The purpose of this study is to evaluate how well this combination treatment works in patients with BRCA-related metastatic breast cancer. Participants in the study will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will take place over a period of time, with regular visits to monitor the effects of the treatment and any changes in the cancer.

Throughout the study, doctors will assess the response of the cancer to the treatment using specific criteria to determine if the cancer is shrinking or staying the same. The goal is to understand the effectiveness of Pembrolizumab and Carboplatin in treating this type of breast cancer and to gather information that could help improve future treatments for patients with similar conditions.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The treatment involves the administration of two medications: pembrolizumab and carboplatin.

    Pembrolizumab is given as an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The specific dosage and frequency will be determined by the healthcare provider based on individual needs.

    Carboplatin is also administered intravenously. The dosage and schedule will be tailored to the patient's condition and response to treatment.

  2. Step 2

    Monitoring and assessment

    Throughout the trial, regular monitoring will occur to assess the response to the treatment. This includes imaging tests to evaluate the size and progression of the cancer.

    The objective response rate, which measures the percentage of patients whose cancer shrinks or disappears after treatment, will be evaluated according to specific criteria.

  3. Step 3

    Follow-up phase

    After completing the treatment phase, follow-up visits will be scheduled to monitor long-term effects and overall health.

    These visits may include physical examinations, blood tests, and imaging studies to ensure the cancer remains under control and to manage any side effects.

Who can join the trial?

13 criteria

  • Be willing and able to provide written permission to participate in the trial.
  • Be 18 years of age or older on the day of signing the permission form.
  • Have breast cancer that has spread to other parts of the body.
  • The disease must have shown growth or spread as seen in medical imaging tests within the last 12 months before signing the permission form.
  • Have a documented change in the BRCA1 or BRCA2 genes that is likely harmful or possibly harmful.
  • Have at least one tumor that can be measured using specific medical guidelines called RECIST v1.1.
  • Have received chemotherapy treatments called anthracyclines and taxanes in the past.
  • Have received no more than one type of chemotherapy for advanced cancer.
  • If the cancer is hormone-sensitive, treatments for advanced disease can be given before.
  • Be willing to provide a sample of tissue from a new biopsy of a tumor. A new sample means it was taken up to 6 weeks before starting treatment. If a new sample cannot be provided due to safety or other reasons, an older sample may be used.
  • Have a performance status of 0 or 1 on the ECOG Performance Scale, which measures how well a person can perform daily activities.
  • Have a life expectancy of more than 3 months.
  • Show that the organs are working well enough, as defined by specific medical tests done within 10 days before starting treatment.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of cancer that is not related to BRCA mutations. BRCA refers to specific genes that, when mutated, can increase the risk of breast cancer.
  • Patients who have not been diagnosed with metastatic breast cancer. Metastatic means that the cancer has spread to other parts of the body.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Pembrolizumab

    is a type of immunotherapy that helps the body's immune system fight cancer cells. It works by blocking a specific protein on the surface of immune cells, allowing them to better recognize and attack cancer cells.

  • Carboplatin

    is a chemotherapy drug that is used to treat various types of cancer. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing, ultimately leading to their death.

What is already known about the treatment

  • Pembrolizumab

    Pembrolizumab is administered intravenously, typically through an infusion into a vein. It is currently well-established in medical literature as an immunotherapy used for various cancers, including BRCA-related metastatic breast cancer. The main therapeutic indication for Pembrolizumab in this context is to enhance the body's immune response against cancer cells. At the molecular level, it works by blocking the PD-1 pathway, which cancer cells use to evade the immune system. Pembrolizumab is classified as a monoclonal antibody in pharmacology.

  • Carboplatin

    Carboplatin is administered intravenously, usually as an infusion. It is a well-known chemotherapy drug used in the treatment of various cancers, including BRCA-related metastatic breast cancer. The primary therapeutic indication is to kill or slow the growth of cancer cells. At the molecular level, Carboplatin works by binding to DNA in cancer cells, causing damage that prevents them from dividing and growing. It is classified as a platinum-based chemotherapy agent.

Investigated diseases

BRCA-related metastatic breast cancer – This is a type of breast cancer that has spread beyond the breast to other parts of the body and is associated with mutations in the BRCA1 or BRCA2 genes. These genetic mutations can lead to the development of cancer at a younger age and may affect the body's ability to repair DNA damage. As the cancer progresses, it can invade nearby tissues and organs, making it more challenging to manage. The disease may cause symptoms such as lumps in the breast, changes in breast shape, and pain in affected areas. Over time, it can spread to bones, liver, lungs, or brain, leading to additional complications. The progression of the disease varies among individuals, influenced by genetic and environmental factors.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515686-34-00Protocol codePEMBRACAEstimated enrolment53 patientsSponsorAzienda Ospedaliero Universitaria Di Modena

sourced from the EU Clinical Trials Register and site verification

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