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BRCA-P: A Cancer Prevention study to determine if Denosumab can prevent Breast Cancer Development in Women carrying a BRCA1 Germline Mutation
EU CTIS ID: 2024-513734-38-00
What this study is testing
To evaluate the reduction in the risk of any breast cancer (invasive or DCIS) in women with germline BRCA1 mutation who are treated with denosumab compared to placebo
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Women with a confirmed deleterious or likely deleterious BRCA 1 germline mutation (Variant class 4 or 5)
- Age ≥ 25 years and ≤ 55 years at randomization
- No evidence of breast cancer by MRI or MG and clinical breast examination within the last 6 months prior to randomization
- No clinical evidence of ovarian cancer at randomization
- Negative pregnancy test at randomization for women of childbearing potential
- No preventive breast surgery planned at time of randomization
You likely can't join if
- Prior bilateral mastectomy
- Participant has a known prior history or current evidence of osteonecrosis or osteomyelitis of the jaw, or an active dental/jaw condition which requires oral surgery including tooth extraction ≤ 3 months prior enrollment
- Concurrent treatment with a bisphosphonate or an anti-angiogenic agent
- Concurrent therapy with other Investigational Products
- Any major medical or psychiatric condition that may prevent the participant from completing the study
- Known active infection with Hepatitis B virus or Hepatitis C virus
See the full eligibility criteria
- Women with a confirmed deleterious or likely deleterious BRCA 1 germline mutation (Variant class 4 or 5)
- Age ≥ 25 years and ≤ 55 years at randomization
- No evidence of breast cancer by MRI or MG and clinical breast examination within the last 6 months prior to randomization
- No clinical evidence of ovarian cancer at randomization
- Negative pregnancy test at randomization for women of childbearing potential
- No preventive breast surgery planned at time of randomization
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Written informed consent before any study-specific procedure is performed
- Prior bilateral mastectomy
- Participant has a known prior history or current evidence of osteonecrosis or osteomyelitis of the jaw, or an active dental/jaw condition which requires oral surgery including tooth extraction ≤ 3 months prior enrollment
- Concurrent treatment with a bisphosphonate or an anti-angiogenic agent
- Concurrent therapy with other Investigational Products
- Any major medical or psychiatric condition that may prevent the participant from completing the study
- Known active infection with Hepatitis B virus or Hepatitis C virus
- Known infection with human immunodeficiency virus (HIV)
- Hypersensitivity to the active substance or to any of the excipients
- Known rare hereditary problems of fructose intolerance
- History of ovarian cancer (including fallopian tube and primary peritoneal cancer)
- History of breast cancer
- History of invasive cancer except for basal cell or squamous cell skin cancer. History of the following are also allowed: carcinoma in situ of the cervix, stage 1 papillary or follicular thyroid cancer, atypical hyperplasia or LCIS (Lobular Carcinoma In Situ)
- Pregnant or lactating women (within the last 2 months prior to randomization)
- Unwillingness to use highly effective contraception method during and within at least 5 months after cessation of denosumab/placebo therapy in women of childbearing potential
- Clinically relevant hypocalcaemia (history and current condition), or serum calcium <2.0 mmol/L (<8.0 mg/dL) or corrected calcium (<2.1 mmol/L) Hypocalcemia defined by calcium below the normal range (a single value below the normal range does not necessarily constitute hypocalcemia, but should be 'corrected' before dosing the participant). Monitoring of calcium level in regular intervals (usually prior to IP administration) is highly recommended
- Tamoxifen, raloxifene or aromatase inhibitor use during the last 3 months prior to randomization or for a duration of more than 3 years in total (current and prior HRT is permitted)
- Any prior use of denosumab
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Israel
- United Kingdom
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Israel; United Kingdom; Australia. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.