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Study on Denosumab to Prevent Breast Cancer in Women with BRCA1 Mutation

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 the prevention of breast cancer in women who carry a specific genetic change known as the BRCA1 germline mutation. The study is investigating whether a medication called Denosumab, which is given as a solution for injection, can help prevent the development of breast cancer in these women. Denosumab is a type of protein-based medication that is already used for other medical conditions.

The purpose of the study is to see if Denosumab can reduce the risk of developing any type of breast cancer, including invasive breast cancer or a condition called DCIS (ductal carcinoma in situ), which is an early form of breast cancer. Participants in the study will receive either Denosumab or a placebo, and the study will compare the outcomes between these two groups. The study will also look at other health outcomes, such as the time it takes for any breast cancer to develop, the occurrence of other types of cancer, and the frequency of breast biopsies.

The study will take place over several years, with participants receiving regular injections and undergoing health assessments to monitor for any signs of breast cancer or other health changes. The goal is to gather information that could lead to new ways to prevent breast cancer in women with the BRCA1 mutation.

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, you will be randomly assigned to receive either the study medication, denosumab, or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug.

    You will be informed about the study procedures and asked to provide written consent to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes confirming your BRCA1 germline mutation status and ensuring there is no evidence of breast cancer through MRI or mammogram and clinical breast examination.

    A negative pregnancy test is required if you are of childbearing potential.

  3. Step 3

    Medication administration

    If you are assigned to the denosumab group, you will receive XGEVA 120 mg as a solution for injection. This will be administered subcutaneously, which means it is injected under the skin.

    The injections will be given at regular intervals as specified by the study protocol.

  4. Step 4

    Regular follow-up visits

    You will attend regular follow-up visits to monitor your health and any potential side effects. These visits will include physical examinations and possibly additional imaging tests.

    The frequency and duration of these visits will be determined by the study protocol.

  5. Step 5

    End of study participation

    Your participation in the study will continue until the estimated end date of July 1, 2030, unless you choose to withdraw earlier or if the study is terminated for any reason.

    At the end of the study, a final assessment will be conducted to evaluate your health and the outcomes of the study.

Who can join the trial?

8 criteria

  • Women with a confirmed harmful or likely harmful change in the BRCA1 gene (known as Variant class 4 or 5).
  • Age between 25 and 55 years at the time of joining the study.
  • No signs of breast cancer as shown by MRI (Magnetic Resonance Imaging) or MG (Mammogram) and a clinical breast exam within the last 6 months before joining the study.
  • No signs of ovarian cancer at the time of joining the study.
  • A negative pregnancy test at the time of joining the study for women who can have children.
  • No plans for preventive breast surgery at the time of joining the study.
  • An ECOG performance status of 0 or 1, which means the person is fully active or has some symptoms but does not need bed rest during the day.
  • Must provide written informed consent before any study-specific procedure is done, meaning they agree to participate after understanding the study details.

Who cannot join the trial?

4 criteria

  • Women who do not have a BRCA1 germline mutation cannot participate. This is a specific change in a gene that can increase the risk of breast cancer.
  • Men are not eligible to participate in this study.
  • Participants must be within a certain age range, which is not specified here.
  • Individuals who are considered part of a vulnerable population may not be eligible. This term refers to groups who might be at a higher risk of harm or exploitation.
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Investigated drugs

Denosumab is a medication used in this clinical trial to help prevent breast cancer in women who have a specific genetic mutation known as BRCA1. This mutation increases the risk of developing breast cancer. Denosumab works by targeting and blocking a protein in the body that is involved in the growth of cancer cells. By doing this, it may help reduce the risk of breast cancer developing in these women. The trial is designed to see how effective denosumab is in preventing breast cancer compared to not using the medication.

What is already known about the treatment

Denosumab – Denosumab is administered as an injection under the skin, typically in the upper arm, thigh, or abdomen. It is currently being studied in clinical trials for its potential to prevent breast cancer in women with a specific genetic mutation known as BRCA1. The main therapeutic indication for this trial is the prevention of breast cancer in women who carry this mutation. At the molecular level, denosumab works by inhibiting a protein involved in bone breakdown, which may also play a role in cancer development. It is classified as a monoclonal antibody, a type of medication that targets specific proteins in the body.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably. It can begin in different parts of the breast, most commonly in the ducts or lobules. The disease progresses as these abnormal cells invade nearby tissues and can spread to other parts of the body. Invasive breast cancer means the cancer cells have spread beyond the original site. Ductal carcinoma in situ (DCIS) is a non-invasive form where cells are confined to the ducts. Over time, DCIS can become invasive if not managed.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513734-38-00Protocol codeBRCA-P/ABCSG 50Estimated enrolment2 918 patientsSponsorANZ Breast Cancer Trials Group Limited

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).