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Study on Olaparib for Patients with Advanced HER2-Negative Breast Cancer and Specific Genetic Mutations

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 the effectiveness of a medication called olaparib, also known by its code name AZD-2281, in treating certain types of breast cancer. The study involves patients with HER2-negative breast cancer that is either locally advanced, meaning it has spread to nearby tissues, or metastatic, meaning it has spread to other parts of the body. Specifically, the trial is looking at patients with mutations in genes such as BRCA1, BRCA2, PALB2, RAD51C, or RAD51D, or those with a low score on a test called the RAD51-foci test.

The purpose of the study is to see if the RAD51-foci score can predict how well olaparib works in treating these types of breast cancer. Participants in the trial will receive olaparib in the form of film-coated tablets, which are taken orally. The study will compare the effects of olaparib with a placebo to determine its effectiveness. The trial will monitor the overall response rate, which measures how many patients experience a reduction in cancer size, and progression-free survival, which is the time during which the cancer does not get worse.

Throughout the study, participants will undergo regular check-ups and assessments to track their response to the treatment. The trial aims to provide valuable information on whether olaparib can be an effective treatment option for patients with these specific genetic mutations or test results. The study is expected to continue until August 2025, with recruitment having started in April 2022.

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

    Joining the study

    Upon joining the study, the patient will provide signed informed consent, confirming understanding and agreement to comply with the study requirements.

    The patient must meet specific health criteria, including normal organ and bone marrow function, and have a life expectancy of at least 16 weeks.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility, which includes a review of medical history and current health status.

    A biopsy of the tumor tissue will be required to evaluate the RAD51-foci score, which helps predict the effectiveness of the treatment.

  3. Step 3

    Treatment initiation

    The patient will begin treatment with olaparib, administered orally in the form of film-coated tablets.

    The dosage will be determined based on the patient's renal function, with a standard dose of 300 mg (two 150 mg tablets) twice daily, or 200 mg (two 100 mg tablets) twice daily for those with moderate renal impairment.

  4. Step 4

    Ongoing treatment and monitoring

    The patient will continue taking olaparib as prescribed, with regular monitoring to assess the response to treatment and any side effects.

    Scheduled visits and examinations will be conducted to evaluate the patient's health and the effectiveness of the treatment.

  5. Step 5

    Evaluation of treatment response

    The patient's response to the treatment will be evaluated using criteria such as tumor size reduction and overall health improvement.

    The primary goal is to determine the overall response rate, which includes complete or partial response to the treatment.

  6. Step 6

    Completion of the study

    The study is expected to conclude by August 31, 2025, at which point the patient's participation will end.

    Final assessments will be conducted to gather data on the treatment's long-term effects and overall outcomes.

Who can join the trial?

21 criteria

  • Must be able to give signed informed consent, agreeing to follow the study's requirements and restrictions.
  • Must have normal organ and bone marrow function, which includes:
    • Hemoglobin level of at least 10.0 g/dL without recent blood transfusion.
    • Absolute neutrophil count (ANC) of at least 1.5 x 109/L.
    • Platelet count of at least 100 x 109/L.
    • Total bilirubin level no more than 1.5 times the normal limit.
    • AST and ALT levels no more than 2.5 times the normal limit, unless liver metastases are present, then no more than 5 times the limit.
    • Creatinine clearance of at least 35 mL/min, which is a measure of kidney function.
    • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, which indicates the ability to carry out daily activities.
    • Must have a life expectancy of at least 16 weeks.
    • Must be willing and able to follow the study protocol, including treatment and scheduled visits.
    • Must provide a tumor sample for testing, which should be of good quality. Certain types of samples are not acceptable.
    • Women must be postmenopausal or have a negative pregnancy test and not be breastfeeding. Postmenopausal status can be due to natural menopause, surgery, or treatment.
    • Male patients must use a condom during treatment and for 3 months after the last dose when having sexual intercourse with a woman who is pregnant or could become pregnant. Female partners should also use effective contraception.
    • Must provide a signed and dated informed consent form before any study procedures.
    • Must be at least 18 years old at the time of signing the informed consent form.
    • Must have confirmed breast cancer that is locally advanced or metastatic and cannot be treated with surgery or radiation to cure it.
    • Must have either triple-negative breast cancer or hormone receptor-positive breast cancer that is HER2-negative, with specific genetic mutations or scores as required by the study.
    • Patients who have received platinum-based chemotherapy for advanced breast cancer can participate if there was no disease progression during treatment and a biopsy was done after treatment.
    • Patients who have received platinum or PARP inhibitors for other cancers or as early treatment for breast cancer can participate if at least 6 months have passed since the last treatment and there is evidence of relapse.
    • Patients with hormone receptor-positive disease must have tried and not responded to at least one line of hormone therapy, with or without CDK4/6 inhibitors, or the doctor must believe hormone therapy is not suitable.
    • Must have at least one measurable tumor that can be assessed by CT or MRI and is suitable for repeated assessment. Previously treated tumors can be considered if there is clear evidence of progression.
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Investigated drugs

Olaparib is a medication used in this trial to treat patients with certain types of advanced breast cancer. It is specifically being tested for its effectiveness in patients who have mutations in the BRCA1, BRCA2, PALB2, RAD51C, or RAD51D genes. The trial aims to see if a specific test, called the RAD51-foci score, can predict how well patients will respond to treatment with olaparib. This medication works by interfering with the cancer cells' ability to repair their DNA, which can help to stop the growth of the 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 in patients with mutations in BRCA1, BRCA2, PALB2, RAD51C, or RAD51D genes. The main therapeutic indication for olaparib is in treating unresectable locally advanced or metastatic HER2-negative breast cancer. At the molecular level, olaparib works by inhibiting the enzyme poly (ADP-ribose) polymerase (PARP), which helps repair DNA damage in cells. By blocking this enzyme, olaparib prevents cancer cells from repairing themselves, leading to their death. It is classified as a PARP inhibitor in pharmacology.

Investigated diseases

  • Triple Negative Breast Cancer (TNBC)

    This is a type of breast cancer that does not have any of the three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and HER2. TNBC is more aggressive and tends to grow and spread faster than other types of breast cancer. It is more common in younger women and those with a BRCA1 gene mutation. The lack of targeted receptors makes it more challenging to treat with hormone therapy or drugs that target HER2 receptors. TNBC often requires a combination of surgery, chemotherapy, and radiation therapy.

  • Hormonal Receptor Positive and HER2-Negative Breast Cancer (HR+/HER2-)

    This type of breast cancer is characterized by the presence of hormone receptors for estrogen or progesterone but lacks the HER2 protein. It is the most common type of breast cancer and tends to grow more slowly than other types. HR+/HER2- breast cancer is often responsive to hormone therapy, which can help slow or stop the growth of the cancer. The disease can occur in both pre and post-menopausal women and sometimes in men. It may become resistant to hormone therapy over time, necessitating alternative treatment strategies.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511875-14-00Protocol codeSOLTI-1910Estimated enrolment63 patientsSponsorSolti Group

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