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Study Comparing Olaparib and Pembrolizumab with Chemotherapy and Pembrolizumab for Patients with Advanced Triple-Negative Breast Cancer

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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 treatments for Triple Negative Breast Cancer (TNBC), a type of breast cancer that does not have any of the three common receptors known to fuel most breast cancer growth. The study involves the use of several medications, including Olaparib, Pembrolizumab, Carboplatin, and Gemcitabine. Olaparib, also known by its code name MK-7339, is a medication taken orally in the form of film-coated tablets. Pembrolizumab, also referred to as MK-3475, is administered as a solution for infusion, which means it is given directly into the bloodstream through a vein. Carboplatin and Gemcitabine are also given as solutions for infusion.

The purpose of this study is to compare the effectiveness of Olaparib plus Pembrolizumab with chemotherapy plus Pembrolizumab in patients who have already shown some benefit from initial treatment with chemotherapy and Pembrolizumab. The study aims to see which combination of treatments helps patients live longer without the cancer getting worse and to compare overall survival rates. Participants will receive either the combination of Olaparib and Pembrolizumab or chemotherapy and Pembrolizumab after their initial treatment phase. The study will monitor the participants' health and response to the treatments over a period of time to gather data on the effectiveness and safety of these treatment combinations.

This trial is designed to help understand which treatment option might be more beneficial for patients with locally recurrent inoperable or metastatic TNBC. The study will involve regular check-ups and assessments to track the progress of the disease and the participants' overall health. The information gathered from this trial could provide valuable insights into better treatment strategies for TNBC in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    Begin with up to 6 cycles of initial treatment. This involves receiving a combination of chemotherapy and pembrolizumab, a medication given through an intravenous (IV) infusion. The specific chemotherapy drugs used are carboplatin and gemcitabine, both administered intravenously.

    During this phase, the response to treatment is evaluated. The goal is to achieve a complete response, partial response, or stable disease.

  2. Step 2

    Evaluation at week 18

    At week 18, an evaluation is conducted to assess the response to the initial treatment. This is done using specific criteria to measure the size and progression of the tumor.

    The evaluation helps determine the next steps in the treatment process.

  3. Step 3

    Post-induction treatment

    If the evaluation shows a positive response, proceed to the next phase of treatment. This involves either continuing with olaparib and pembrolizumab or switching to a combination of chemotherapy and pembrolizumab.

    Olaparib is taken orally in the form of film-coated tablets. The specific dosage and frequency will be provided by the healthcare team.

    The choice of treatment depends on the response to the initial phase and the specific characteristics of the cancer.

  4. Step 4

    Ongoing monitoring

    Throughout the trial, regular monitoring is conducted to assess the effectiveness of the treatment and any side effects experienced.

    This includes routine medical check-ups, imaging tests, and laboratory tests to ensure the treatment is working as intended and to manage any potential side effects.

  5. Step 5

    End of trial

    The trial is expected to continue until January 2026. The duration of participation may vary depending on individual response to treatment and other factors.

    At the end of the trial, a final evaluation is conducted to assess the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

14 criteria

  • The patient must have Triple Negative Breast Cancer (TNBC) that has come back and cannot be removed by surgery, or has spread to other parts of the body, and has not been treated with chemotherapy before.
  • If the patient is a woman who can have children, she must not be pregnant or breastfeeding. She must have a negative pregnancy test within 24 hours before starting the study treatment and agree to use birth control or not have sex during the study and for a certain time after.
  • The patient must have received between 4 to 6 cycles of initial treatment without stopping the use of pembrolizumab or both carboplatin and gemcitabine.
  • The patient must have shown a complete response, partial response, or stable disease based on specific criteria at the Week 18 evaluation.
  • The patient must be able to take the first doses of olaparib and pembrolizumab or at least one of the chemotherapy drugs (carboplatin and/or gemcitabine) along with pembrolizumab after the initial treatment.
  • The patient must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but do not need to stay in bed.
  • The patient must not have more than mild side effects from the initial treatment, except for hair loss, before being randomly assigned to a treatment group.
  • If the patient received treatment before surgery or after surgery, they must have been treated with anthracycline and/or a taxane unless these were not suitable for them.
  • The patient must have a disease that can be measured based on specific criteria.
  • The patient must provide a recent or past biopsy sample of a tumor that has not been treated with radiation.
  • The patient must be at least 18 years old.
  • The patient must have a life expectancy of at least 27 weeks from the start of the study treatment.
  • The patient must have adequate organ function within 10 days before starting the study treatment.
  • If the patient is male, he must agree to use birth control or not have sex and not donate sperm during the study and for a certain time after.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have had another cancer treatment recently.
  • Patients with severe or uncontrolled medical conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have allergies to the study medications.
  • Patients who are unable to follow the study procedures.
  • Patients who have participated in another clinical trial recently.
  • Patients with a history of certain heart conditions.
  • Patients with active infections that require treatment.
  • Patients who have had a major surgery recently.
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Investigated drugs

  • Olaparib

    is a type of medication known as a PARP inhibitor. It works by blocking an enzyme that cancer cells need to repair their DNA. By preventing this repair, olaparib can help to stop the growth of cancer cells and may lead to their death. In this trial, olaparib is being tested to see if it can help improve outcomes for patients with a specific type of breast cancer when used in combination with another medication.

  • Pembrolizumab

    is an immunotherapy drug that helps the body's immune system fight cancer. It works by blocking a protein called PD-1, which can prevent the immune system from attacking cancer cells. By blocking this protein, pembrolizumab can help the immune system recognize and destroy cancer cells more effectively. In this trial, it is used in combination with other treatments to see if it can improve the survival of patients with breast cancer.

  • Chemotherapy

    refers to a group of drugs that are used to kill or slow the growth of cancer cells. These drugs work by targeting rapidly dividing cells, which include cancer cells. Chemotherapy is a common treatment for many types of cancer and is often used in combination with other therapies to enhance its effectiveness. In this trial, chemotherapy is combined with pembrolizumab to evaluate its impact on patients with breast cancer.

What is already known about the treatment

  • Olaparib

    Olaparib is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating certain types of breast cancer, specifically locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC). The main therapeutic indication for olaparib is to help improve survival rates in patients with this type of cancer. At the molecular level, olaparib works by inhibiting an enzyme called PARP, which helps repair damaged DNA in cancer cells, thereby preventing them from growing and dividing. It is classified as a PARP inhibitor in pharmacology.

  • Pembrolizumab

    Pembrolizumab is administered through an intravenous infusion. It is widely used in medicine and is being further studied in clinical trials for its role in treating various cancers, including triple-negative breast cancer (TNBC). The main therapeutic indication for pembrolizumab is to enhance the body's immune response against cancer cells. At the molecular level, pembrolizumab works by blocking a protein called PD-1 on immune cells, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor in pharmacology.

Investigated diseases

Triple Negative Breast Cancer (TNBC) – Triple Negative Breast Cancer is a type of breast cancer that lacks three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER-2/neu gene. This absence makes it more challenging to treat, as hormone therapies and drugs targeting HER-2 are ineffective. TNBC tends to grow and spread more quickly than other types of breast cancer. It is often diagnosed at a higher grade, meaning the cancer cells look more abnormal and are more likely to spread. The disease can be locally recurrent, meaning it returns in the same area, or metastatic, meaning it spreads to other parts of the body. TNBC is more common in younger women and those with a BRCA1 gene mutation.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2022-500418-24-00Protocol codeMK-7339-009Estimated enrolment276 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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