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Study on Talazoparib for Advanced Breast Cancer Patients Using the RECAP Test

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 breast cancer, specifically advanced stages of the disease. The treatment being tested is a medication called Talazoparib, which is taken in the form of hard capsules. Talazoparib is a type of drug known as a PARP inhibitor, which works by interfering with cancer cells' ability to repair themselves, potentially slowing down or stopping their growth.

The purpose of the study is to determine if a test called the RECAP test can help identify patients who are more likely to benefit from treatment with Talazoparib. The study will involve patients with advanced breast cancer, including those with specific types of the disease, such as ER-positive and HER2-negative breast cancer, as well as triple-negative breast cancer. The trial will also include patients with certain genetic mutations, like BRCA1 and BRCA2, which are known to affect how breast cancer develops and responds to treatment.

Participants in the study will receive Talazoparib and will be monitored over a period to see how their cancer responds to the treatment. Some patients may receive a placebo instead of the actual medication. The main goal is to see how many patients experience a period of time without their cancer getting worse, known as progression-free survival, for at least four months. The study will also look at other outcomes, such as overall response to the treatment and overall survival rates among participants.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    The trial begins with an initial assessment to confirm eligibility. This includes a review of medical history and current health status.

    Eligibility criteria include being over 18 years old, having a specific type of breast cancer, and meeting certain health requirements such as adequate blood counts and organ function.

  2. Step 2

    Biopsy and RECAP test

    A biopsy is performed to obtain a sample of the tumor. This sample is used for the RECAP test, which assesses the tumor's repair capacity.

    The RECAP test helps determine if the tumor is likely to respond to the treatment with talazoparib.

  3. Step 3

    Treatment initiation

    If the RECAP test indicates potential sensitivity to talazoparib, treatment begins.

    The medication used is Talzenna 1 mg hard capsules, taken orally.

  4. Step 4

    Treatment schedule

    The talazoparib capsules are taken once daily.

    The treatment continues as long as it is effective and tolerated, with regular monitoring.

  5. Step 5

    Monitoring and evaluation

    Regular check-ups are conducted to monitor the response to treatment and any side effects.

    The primary goal is to assess the progression-free survival (PFS) at 4 months, which means the length of time during and after treatment that the cancer does not get worse.

  6. Step 6

    End of trial

    The trial is estimated to conclude by December 30, 2026.

    Final evaluations will be conducted to assess overall response and survival rates among participants.

Who can join the trial?

17 criteria

  • Must be older than 18 years.
  • Must have a **hemoglobin** level of at least 10 g/dL and **ANC** (a type of white blood cell count) of at least 1.5 x 109/L.
  • Must have **platelets** (a type of blood cell) greater than 100 x 109/L.
  • Must have normal **liver function**, with total **serum bilirubin** no more than 1.5 times the upper limit of normal (ULN), except if elevated due to **Gilbert's disease** or a similar condition. **ASAT** and **ALAT** (liver enzymes) should be less than 3 times ULN.
  • Must have normal **kidney function**, with **serum creatinine** no more than 1.5 times ULN or **creatinine clearance** of at least 50 mL/min.
  • Female patients with childbearing potential must have a negative pregnancy test.
  • Must provide written informed consent to participate in the study.
  • Must have a **WHO performance status** of 0 to 2, which indicates the ability to carry out daily activities.
  • Must have **locally advanced breast cancer** that cannot be cured or **metastatic breast cancer** (cancer that has spread to other parts of the body).
  • The breast cancer must be one of the following types:
    • High grade (Bloom & Richardson grade 3) **ER positive** (more than 10%) and **HER2 negative** primary breast cancer.
    • **Triple negative** breast cancer (ER less than 10%, PR less than 10%, and HER2 negative).
    • Any Bloom & Richardson grading and receptor status with at least one **metastatic lesion** having a proven **HRD phenotype** based on a **RECAP test** not treated with anticancer therapy thereafter, or the patient must have a proven **BRCA1** and/or **BRCA2 mutation**.
    • The site of the metastatic lesion (or primary tumor if still present) should be easily accessible for a biopsy. Lung metastases and bone metastases are excluded due to risks and interference with tests.
    • The tumor must be **HRD**, identified by the RECAP test before starting potential **Talazoparib** treatment, or a proven germline BRCA1/2 mutation must be present.
    • Must have had no more than four prior lines of chemotherapy for advanced disease. Patients who received **platinum compounds** are eligible if they had at least a four-month period without disease progression.
    • Must have **measurable or evaluable disease** according to **RECIST 1.1 criteria**.
    • Must have a life expectancy of at least 3 months.

Who cannot join the trial?

4 criteria

  • Patients who are not diagnosed with breast cancer cannot participate. Breast cancer is a type of cancer that forms in the cells of the breasts.
  • Patients who are not within the specified age range cannot participate. The age range for this study is not specified in the provided data.
  • Patients who are not sensitive to treatment with the PARP inhibitor talazoparib cannot participate. A PARP inhibitor is a type of medication that helps prevent cancer cells from repairing themselves, and talazoparib is a specific drug used in this treatment.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups of people who may be at a higher risk of harm or exploitation.
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Investigated drugs

Talazoparib is a medication used in this trial to treat advanced breast cancer. It works by blocking an enzyme called PARP, which helps repair damaged DNA in cells. By inhibiting this enzyme, talazoparib can prevent cancer cells from repairing themselves, leading to their death. This medication is being tested to see if it is effective for patients selected using the RECAP test, which identifies those who might respond well to this treatment.

What is already known about the treatment

Talazoparib – Talazoparib is administered orally in the form of capsules. It is currently being studied in clinical trials for its effectiveness in treating advanced breast cancer. The main therapeutic indication for Talazoparib is breast cancer, particularly in patients who may be sensitive to this treatment. At the molecular level, Talazoparib works by inhibiting the PARP enzyme, which plays a role in repairing damaged DNA in cancer cells, leading to cell death. It is classified as a PARP inhibitor in pharmacology.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably, forming a tumor that can often be felt as a lump. It typically begins in the ducts or lobules of the breast and can spread to other parts of the body if not managed. The progression of breast cancer can vary, with some tumors growing slowly and others more rapidly. Hormone receptor status and genetic factors can influence the behavior and growth rate of the cancer. Early stages may not cause noticeable symptoms, but as it progresses, changes in breast shape, size, or skin texture may occur. Regular screening and awareness of changes in the breast are important for early detection.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518036-36-03Estimated enrolment78 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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