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Study of Durvalumab, Olaparib, and Fulvestrant for Patients with ER-Positive, HER2-Negative Advanced Breast Cancer with Specific Genetic Alterations

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 a type of breast cancer known as ER-positive, HER2-negative breast cancer. This type of cancer can be either metastatic, meaning it has spread to other parts of the body, or locally advanced, meaning it has grown significantly in the breast or nearby areas. The study is particularly interested in patients who have specific genetic changes, such as mutations in the BRCA genes or other genes involved in a process called homologous recombination repair (HRR). These genetic changes can affect how the cancer responds to treatment.

The trial is testing a combination of three treatments: durvalumab, also known by its code name MEDI4736, olaparib, and fulvestrant. Durvalumab is given as an infusion into a vein, olaparib is taken as a tablet, and fulvestrant is given as an injection. The purpose of the study is to evaluate how effective this combination is in treating the specific type of breast cancer mentioned above. The study will also look at the safety of these treatments when used together.

Participants in the study will receive the treatments over a period of time, and their health will be monitored regularly. The main goal is to see if the cancer stops growing or shrinks within 24 weeks of starting the treatment. The study will also track how long patients live without the cancer getting worse and any side effects they might experience. This information will help doctors understand if this combination of treatments could be a good option for patients with this type of breast cancer in the future.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and consent

    Upon joining the study, you will attend an initial visit where the study team will explain the trial in detail. You will be asked to provide written informed consent, confirming your understanding and willingness to participate in the study.

  2. Step 2

    Screening and baseline assessments

    You will undergo various assessments to confirm eligibility, including blood tests, imaging scans, and a review of your medical history. These tests ensure that you meet the study criteria and establish baseline health data.

  3. Step 3

    Treatment initiation

    Once eligibility is confirmed, you will begin the treatment phase. You will receive a combination of medications: fulvestrant as a 250 mg solution for injection administered intramuscularly, olaparib as 100 mg or 150 mg film-coated tablets taken orally, and durvalumab as a 50 mg/mL concentrate for solution for infusion administered intravenously. Additionally, goserelin acetate will be provided as a 3.6 mg implant administered subcutaneously.

  4. Step 4

    Treatment schedule

    The treatment will be administered according to a specific schedule. Fulvestrant injections are typically given every two weeks for the first three doses, then once a month. Olaparib tablets are taken twice daily. Durvalumab infusions are given every four weeks. Goserelin acetate implants are administered every 28 days.

  5. Step 5

    Regular monitoring and assessments

    Throughout the trial, you will have regular visits for monitoring your health and the effects of the treatment. This includes physical exams, blood tests, and imaging scans to assess the progression of the disease and any side effects.

  6. Step 6

    End of treatment evaluation

    At the end of the treatment period, a comprehensive evaluation will be conducted to assess the overall impact of the treatment on your condition. This includes final imaging scans and laboratory tests.

  7. Step 7

    Follow-up period

    After completing the treatment, you will enter a follow-up period where your health will continue to be monitored at regular intervals. This helps to gather long-term data on the treatment's effectiveness and any lasting effects.

Who can join the trial?

12 criteria

  • Must have a confirmed diagnosis of ER-positive (estrogen receptor-positive) and HER2-negative breast cancer that is either metastatic (spread to other parts of the body) or locally advanced (grown into nearby tissues).
  • Must be a woman of childbearing potential or a man, and agree to use effective birth control during the study and for 6 months after the last dose of the study drug.
  • Must provide written consent to participate in the study.
  • Must be willing and able to follow the study rules for the entire duration.
  • Must be at least 18 years old.
  • Must have a documented change in the BRCA1 or BRCA2 genes, or other specific gene changes related to HRR (homologous recombination repair) or MSI (microsatellite instability) status.
  • Must have a life expectancy of at least 16 weeks.
  • Must have an ECOG performance status of 0-1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
  • Must have at least one tumor that can be measured or evaluated by a CT scan or MRI.
  • In the case of metastatic cancer, must have received one line of hormone therapy with a CDK4/6 inhibitor and possibly one line of chemotherapy.
  • Must have adequate organ and bone marrow function, including specific levels of hemoglobin, neutrophils, platelets, bilirubin, liver enzymes (AST/ALT), and kidney function (creatinine clearance).
  • For women of childbearing potential, must have a negative pregnancy test within 28 days before starting the study treatment and confirmed on the first day of treatment.

Who cannot join the trial?

7 criteria

  • Patients who do not have **ER-positive** and **HER2-negative** breast cancer. ER-positive means the cancer grows in response to the hormone estrogen. HER2-negative means the cancer does not have high levels of the protein HER2.
  • Patients without a **BRCA mutation**. A BRCA mutation is a change in one of the BRCA genes, which can increase the risk of breast cancer.
  • Patients without changes in other genes involved in **homologous recombination repair (HRR)**. HRR is a process that helps repair DNA damage in cells.
  • Patients without changes in **MSI status**. MSI stands for microsatellite instability, which is a condition of genetic hypermutability that can affect cancer development.
  • Patients who are not within the specified age range for the study.
  • Patients who are not female or male, as both genders are eligible.
  • Patients who are part of a vulnerable population, as they are not selected for this study.
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Investigated drugs

  • Durvalumab

    is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, it is used to help your body fight breast cancer that is either metastatic, meaning it has spread to other parts of the body, or locally advanced, meaning it is large or has spread to nearby tissues.

  • Olaparib

    is a medication that targets cancer cells with specific genetic changes. It is known as a PARP inhibitor and works by preventing cancer cells from repairing themselves, which can lead to their death. This medication is used in this trial to treat breast cancer in patients who have certain genetic alterations that make their cancer more sensitive to this type of treatment.

  • Fulvestrant

    is a hormone therapy used to treat breast cancer. It works by blocking the effects of estrogen, a hormone that can promote the growth of breast cancer cells. In this trial, fulvestrant is used to help control the growth of cancer in patients with ER-positive breast cancer, which means the cancer cells grow in response to estrogen.

What is already known about the treatment

  • Durvalumab

    Durvalumab is administered as an intravenous infusion, meaning it is given directly into a vein. It is currently being studied in clinical trials for its effectiveness in treating certain types of breast cancer, specifically ER-positive and HER2-negative metastatic or locally advanced breast cancer with specific genetic mutations. The main therapeutic indication is to help the immune system recognize and attack cancer cells. At the molecular level, Durvalumab works by blocking a protein called PD-L1, which can prevent the immune system from attacking cancer cells. It is classified as an immune checkpoint inhibitor.

  • Olaparib

    Olaparib is taken orally in the form of tablets. It is being investigated in clinical trials for its potential to treat breast cancer with specific genetic mutations, such as BRCA mutations. The main therapeutic indication is to target cancer cells with these mutations and prevent them from repairing their DNA, leading to cell death. At the molecular level, Olaparib inhibits an enzyme called PARP, which is involved in DNA repair. It is classified as a PARP inhibitor.

  • Fulvestrant

    Fulvestrant is administered as an injection into the muscle, typically in the buttocks. It is used in clinical trials to treat certain types of breast cancer, specifically ER-positive and HER2-negative metastatic or locally advanced breast cancer. The main therapeutic indication is to block the effects of estrogen on cancer cells, which can slow or stop their growth. At the molecular level, Fulvestrant binds to estrogen receptors and degrades them, reducing the cancer cells' ability to use estrogen. It is classified as an estrogen receptor antagonist.

Investigated diseases

ER-positive and HER2-negative metastatic or locally advanced breast cancer with BRCA mutation or HRR/MSI gene alterations – This type of breast cancer is characterized by the presence of estrogen receptors (ER-positive) and the absence of human epidermal growth factor receptor 2 (HER2-negative). It can occur in a metastatic form, meaning it has spread to other parts of the body, or as locally advanced, where it has spread to nearby tissues or lymph nodes. The cancer is associated with mutations in the BRCA genes or other genes involved in homologous recombination repair (HRR) or microsatellite instability (MSI). These genetic alterations can affect the way cancer cells repair DNA damage, potentially leading to more aggressive tumor behavior. The disease progresses as cancer cells continue to grow and spread, potentially affecting various organs and systems in the body. The progression can vary widely among individuals, influenced by genetic factors and the cancer's response to the body's environment.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516847-23-00Protocol codeUC-0140/1812Estimated enrolment172 patientsSponsorUnicancer

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