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Study on the Effectiveness and Safety of Olaparib Alone and with Durvalumab for Patients with Early Stage HER2-Negative Breast Cancer with BRCA 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 and safety of treatments for patients with BRCA mutations and early-stage HER2-negative breast cancer. The study involves two main treatments: Olaparib, which is taken as a tablet, and a combination of Olaparib with Durvalumab, which is given as an infusion. Olaparib is a medication that targets cancer cells with specific genetic mutations, while Durvalumab is an immunotherapy that helps the immune system fight cancer.

The purpose of the study is to evaluate how well these treatments work when given before surgery, known as neoadjuvant therapy. Participants will receive either Olaparib alone or in combination with Durvalumab over a period of time. The study will monitor the response of the cancer to these treatments, including changes in tumor size and the absence of cancer in tissue samples after treatment. The study will also assess the safety of the treatments by monitoring any side effects experienced by participants.

Throughout the study, participants will undergo various assessments, including imaging tests like MRI to measure changes in tumor size. The study aims to provide valuable information on the potential benefits of using these treatments in patients with specific genetic profiles and cancer types. The findings could help improve treatment options for individuals with BRCA mutations and early-stage HER2-negative breast cancer.

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, eligibility is confirmed based on specific criteria, including age, weight, and medical history related to breast cancer and BRCA mutations.

    A baseline biopsy is required to collect tissue samples for research purposes.

  2. Step 2

    Initial treatment phase

    The treatment begins with the administration of olaparib as monotherapy. Olaparib is taken orally in the form of film-coated tablets.

    The dosage and frequency of olaparib are determined by the study protocol and are adjusted based on individual response and tolerance.

  3. Step 3

    Combination therapy phase

    Following the initial phase, a combination therapy of olaparib and durvalumab is introduced.

    Durvalumab is administered intravenously as a solution for infusion.

    The combination therapy aims to enhance the treatment efficacy and is monitored closely for safety and effectiveness.

  4. Step 4

    Monitoring and assessment

    Throughout the trial, regular assessments are conducted to monitor the response to treatment.

    These assessments include imaging tests like MRI to measure changes in tumor volume after 3 and 6 cycles of treatment.

    Safety evaluations are performed, including physical examinations, vital signs, and laboratory tests.

  5. Step 5

    Completion of treatment

    Upon completion of the neoadjuvant therapy, a surgical evaluation is conducted to assess the absence of invasive cancer in the breast and lymph nodes.

    The primary goal is to achieve a pathological complete response, indicating no residual invasive cancer.

  6. Step 6

    Follow-up

    After the treatment phase, follow-up visits are scheduled to monitor long-term outcomes and any potential recurrence of cancer.

    The follow-up period extends until the estimated end date of the trial in April 2027.

Who can join the trial?

13 criteria

  • Participants can be males or females who are 18 years or older.
  • Participants must weigh at least 30 kg (about 66 pounds).
  • Participants must be able to provide signed informed consent, which means they understand the study and agree to participate.
  • Participants who can have children must use effective birth control methods during the study.
  • Participants must have a specific type of breast cancer that is newly diagnosed, can be operated on, and has not spread to other parts of the body. The cancer must be:
  • ER-negative or ER-low, meaning the cancer cells have little or no estrogen receptors.
  • HER2-negative, meaning the cancer does not have high levels of the HER2 protein.
  • The cancer must be at a certain stage, which is determined by its size and whether it has spread to nearby lymph nodes, but not to other parts of the body.
  • Participants must have a BRCA1 or BRCA2 mutation, which is a change in certain genes that can increase the risk of breast cancer.
  • Participants 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.
  • Participants must have adequate organ and bone marrow function, meaning their organs and bone marrow are working well enough for the study.
  • Participants must agree to have a core needle biopsy before starting the study treatment. This is a procedure where a small sample of tissue is taken from the tumor for research.
  • Participants must agree to provide any leftover tumor tissue from the initial biopsy for research, if available.

Who cannot join the trial?

12 criteria

  • Patients who do not have a BRCA mutation. This is a change in a specific gene that can increase the risk of certain cancers.
  • Patients with HER2-positive breast cancer. HER2 is a protein that can promote the growth of cancer cells, and HER2-positive means there is a lot of this protein.
  • Patients who are not in the early stage of breast cancer. Early stage means the cancer is small and has not spread much.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to understand or agree to the study requirements.
  • Patients who are pregnant or breastfeeding.
  • Patients with other serious health conditions that could interfere with the study.
  • Patients who have had another cancer within the last 5 years, except for certain types of skin cancer or cervical cancer that has been treated.
  • Patients who have received certain treatments for cancer recently, such as chemotherapy or radiation.
  • Patients who are taking medications that could interfere with the study drugs.
  • Patients who have allergies to the study drugs or similar drugs.
  • Patients who have participated in another clinical trial recently.
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Investigated drugs

  • Olaparib

    is a medication used in this trial as a monotherapy. It is designed to treat patients with specific genetic mutations, such as BRCA mutations, which are linked to certain types of cancer. In this study, it is being tested for its effectiveness in treating early-stage HER2-negative breast cancer.

  • Durvalumab

    is another medication used in combination with Olaparib in this trial. It is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells. The combination of Durvalumab with Olaparib is being evaluated to see if it improves treatment outcomes for patients with early-stage HER2-negative 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 patients with BRCA mutations and early-stage HER2-negative breast cancer. The main therapeutic indication for olaparib is as a neoadjuvant therapy, which means it is used before the main treatment to shrink tumors. At the molecular level, olaparib works by inhibiting the enzyme PARP, which helps repair DNA damage in cells, leading to cancer cell death. It is classified as a PARP inhibitor in pharmacology.

  • Durvalumab

    Durvalumab is administered through intravenous infusion. It is being investigated in combination with olaparib for its potential benefits in treating early-stage HER2-negative breast cancer with BRCA mutations. The primary therapeutic use of durvalumab in this context is to enhance the immune system's ability to fight cancer. It works by blocking the PD-L1 protein, which can prevent the immune system from attacking cancer cells. Durvalumab is classified as an immune checkpoint inhibitor.

Investigated diseases

BRCA Mutations and Early Stage HER2-Negative Breast Cancer – This condition involves genetic mutations in the BRCA1 or BRCA2 genes, which are linked to an increased risk of developing breast cancer. In this context, the cancer is classified as HER2-negative, meaning it does not overexpress the HER2 protein, which is a common target for certain cancer therapies. The disease typically begins in the breast tissue and may progress to involve nearby lymph nodes. It is characterized by the growth of malignant cells that can invade surrounding tissues. The progression of the disease can vary, with some cases remaining localized while others may spread to other parts of the body. Early detection and monitoring are crucial for managing the disease effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503529-20-00Protocol codeOlympiaNEstimated enrolment50 patientsSponsorAstraZeneca AB

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