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Study on Olaparib for Patients with High-Risk HER2-Negative Breast Cancer and BRCA1/2 Mutations After Chemotherapy

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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 effects of a medication called olaparib on patients with a specific type of breast cancer. The study involves patients who have a genetic mutation known as BRCA1 or BRCA2 and have a high risk of a type of breast cancer that is HER2-negative. These patients have already completed their main cancer treatments, including surgery and chemotherapy. The purpose of the study is to see how well olaparib works as an additional treatment to help prevent the cancer from coming back.

Participants in the study will be randomly assigned to receive either olaparib or a placebo, which looks like the medication but does not contain the active ingredient. The study is designed to be "double-blind," meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are not biased. The treatment will be given in the form of film-coated tablets, which are taken by mouth.

The study will last for a period of up to 12 months, during which time the participants will be monitored for their health and any changes in their condition. The main goal is to assess the "Invasive Disease Free Survival" (IDFS), which means the length of time the patients remain free from cancer that has spread or returned. Other aspects, such as overall survival and the occurrence of new cancers, will also be observed. The study aims to provide valuable information on the safety and effectiveness of olaparib as an additional treatment for this type of breast cancer.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age, type of breast cancer, and genetic mutations.

    The study involves patients with a specific type of breast cancer who have completed certain treatments.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the medication olaparib or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

  3. Step 3

    Medication administration

    Participants take olaparib in the form of film-coated tablets. The dosage is either 150 mg or 100 mg, taken orally.

    The medication is taken as part of the study's adjuvant treatment phase, which follows the completion of previous cancer treatments.

  4. Step 4

    Monitoring and assessments

    Throughout the study, participants undergo regular monitoring to assess the effectiveness and safety of the treatment.

    Assessments include tracking Invasive Disease Free Survival (IDFS) and other health outcomes.

  5. Step 5

    Completion of study

    The study is expected to conclude by May 2029. Participants will continue to be monitored until the study's end date to gather comprehensive data on the treatment's long-term effects.

Who can join the trial?

8 criteria

  • Must be **18 years old or older**.
  • Must have a type of **breast cancer** that is not spread to other parts of the body. This cancer should be confirmed by a test called a **histology** test.
  • The breast cancer must be one of these types:
    • **TNBC**: This means the cancer is negative for **ER** (estrogen receptor), **PgR** (progesterone receptor), and **HER2** (a protein that can promote the growth of cancer cells).
    • **ER and/or PgR positive, HER2 negative**: This means the cancer is positive for estrogen and/or progesterone receptors but negative for HER2.
    • Must have a **germline mutation** in the **BRCA1** or **BRCA2** genes. This means there is a change in these genes that is known or suspected to be harmful.
    • Must have completed surgery on the breast and underarm area (called the **axilla**).
    • Must have completed at least **6 cycles of chemotherapy** before or after surgery. This chemotherapy should include drugs called **anthracyclines** and **taxanes**. Previous treatment with a drug called **platinum** for other cancers or as part of breast cancer treatment is allowed.
    • Must have an **ECOG performance status** of 0 or 1. This is a scale that measures how well a person can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.

Who cannot join the trial?

9 criteria

  • Patients who are currently pregnant or breastfeeding cannot participate.
  • Individuals with a history of another type of cancer, except for breast cancer, are excluded.
  • Patients who have had a heart attack or stroke in the past 6 months are not eligible.
  • Those with severe kidney or liver disease cannot join the study.
  • Patients who are allergic to the study medication, **olaparib**, are excluded. **Olaparib** is a type of medication used in cancer treatment.
  • Individuals who are unable to follow the study procedures or attend follow-up visits are not eligible.
  • Patients who are currently participating in another clinical trial are excluded.
  • Individuals with uncontrolled high blood pressure cannot participate.
  • Patients with a known infection, such as **HIV** or **hepatitis**, are not eligible. **HIV** is a virus that affects the immune system, and **hepatitis** is an infection that affects the liver.
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Investigated drugs

Olaparib is a medication used in this clinical trial to assess its effectiveness and safety as an additional treatment for patients with specific genetic mutations (BRCA1/2) and a type of breast cancer that does not have the HER2 protein. The trial aims to see if olaparib can help prevent the return of cancer after patients have already received standard treatments like surgery and chemotherapy.

What is already known about the treatment

Olaparib – This medication is administered orally in the form of tablets. It is currently being studied in clinical trials as an adjuvant treatment for patients with specific genetic mutations and high-risk breast cancer. Olaparib is primarily used for treating breast cancer, particularly in patients with BRCA1/2 mutations. It works by inhibiting an enzyme called PARP, which helps repair damaged DNA 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

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 types growing slowly and others more rapidly. It is often categorized by stages, which describe the size of the tumor and the extent of its spread. Early detection is crucial for managing the disease effectively. Breast cancer can affect both men and women, though it is much more common in women.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511096-15-00Protocol codeD081CC00006Estimated enrolment1 800 patientsSponsorAstraZeneca AB

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