Denosumab to Prevent Breast Cancer in Women With BRCA1 Mutation
(BRCA-P Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines whether denosumab, a treatment for managing bone loss, can help prevent breast cancer in women with a BRCA1 gene mutation. This mutation increases breast cancer risk, and researchers aim to determine if denosumab can lower that risk compared to a placebo (a substance with no active treatment). Women with a confirmed BRCA1 mutation who haven't had breast cancer or preventive breast surgery, and do not plan to, might be suitable for this trial. Participants will receive either denosumab or a placebo every six months for up to five years. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking research.
Do I have to stop taking my current medications for this trial?
The trial does not specify if you must stop all current medications, but you cannot use tamoxifen, raloxifene, aromatase inhibitors, bisphosphonates, or anti-angiogenic agents. If you've used tamoxifen, raloxifene, or aromatase inhibitors in the last 3 months or for more than 3 years total, you cannot participate. Current or prior use of aspirin or NSAIDs is allowed.
Will I have to stop taking my current medications?
The trial requires that you stop using tamoxifen, raloxifene, or aromatase inhibitors if you've used them in the last 3 months or for more than 3 years in total. You also cannot be on bisphosphonates or anti-angiogenic agents. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.
Is there any evidence suggesting that denosumab is likely to be safe for humans?
Research shows that denosumab is generally safe for people. In past studies, it treated bone loss and helped prevent new bone growths in cancer patients with bone metastases. The FDA has approved denosumab for these uses, indicating a known safety record.
In studies on breast cancer risk, denosumab was associated with a 13% reduction in risk for postmenopausal women. These studies did not find major safety issues, which reassures those considering joining the trial.
Since this trial is in its later stages, substantial data already supports the safety of denosumab, indicating most people tolerate it well. Participants in other studies have not reported major side effects. However, like any medication, it can cause some side effects, so discussing any concerns with the trial team is important.1234Why do researchers think this study treatment might be promising?
Denosumab is unique because it targets a specific pathway involved in bone resorption, which may help prevent breast cancer in women with a BRCA1 mutation. Most treatments for breast cancer focus on hormone therapy, chemotherapy, or surgery, but denosumab works by inhibiting the RANK ligand, a protein that plays a role in the development of breast cancer. Researchers are excited about denosumab because it offers a novel approach by potentially stopping cancer before it starts, particularly for those with a genetic predisposition, and it is administered as a simple injection every six months, making it a convenient option.
What evidence suggests that denosumab might be an effective treatment for preventing breast cancer in women with a BRCA1 mutation?
Research has shown that denosumab, which participants in this trial may receive, might lower the risk of breast cancer in women with a BRCA1 gene mutation. One study found that using denosumab was linked to a 13% lower chance of developing breast cancer. This medication is a monoclonal antibody, targeting specific cells in the body. Denosumab is already used to support bone health and prevent bone problems in cancer patients. These findings suggest that denosumab could effectively prevent breast cancer in those with a BRCA1 mutation.12345
Who Is on the Research Team?
Judy E. Garber, MD, MPH
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
Women aged 25-55 with a BRCA1 gene mutation, no breast or ovarian cancer, and not planning preventive breast surgery can join. They must have normal recent breast exams, not be pregnant or breastfeeding, agree to use contraception, and have good physical health.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive denosumab or placebo subcutaneously every 6 months for up to 5 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Denosumab
- Quality-of-Life Assessment
Denosumab is already approved in European Union, United States, Canada, Japan for the following indications:
- Osteoporosis in postmenopausal women
- Bone loss associated with hormone ablation therapy for prostate cancer
- Bone loss associated with hormone ablation therapy for breast cancer
- Treatment of postmenopausal women with osteoporosis at high risk for fracture
- Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
- Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer
- Treatment of osteoporosis in postmenopausal women at high risk for fracture
- Treatment to increase bone mass in men with osteoporosis at high risk for fracture
- Treatment of osteoporosis in postmenopausal women
- Treatment of bone loss associated with hormone ablation therapy for prostate cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance for Clinical Trials in Oncology
Lead Sponsor
Austrian Breast & Colorectal Cancer Study Group (ABCSG)
Collaborator
National Cancer Institute (NCI)
Collaborator