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Monoclonal Antibodies

Denosumab to Prevent Breast Cancer in Women With BRCA1 Mutation (BRCA-P Trial)

Phase 3
Recruiting
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post treatment
Awards & highlights

BRCA-P Trial Summary

This trial is testing whether denosumab can prevent breast cancer in women with a BRCA1 gene mutation, which is linked to a higher risk of developing the disease.

Who is the study for?
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.Check my eligibility
What is being tested?
The trial is testing if Denosumab can prevent breast cancer in women with the BRCA1 mutation compared to a placebo. It's a phase III study where participants are randomly given either Denosumab or an inactive substance while their quality of life is monitored.See study design
What are the potential side effects?
Denosumab may cause issues like jaw bone problems (osteonecrosis), low calcium levels in the blood (hypocalcemia), infection risks, and possibly interfere with healing after dental procedures.

BRCA-P Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a harmful BRCA1 gene mutation.
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I am between 25 and 55 years old.
Select...
I currently show no signs of ovarian cancer.
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I am not planning to have preventive breast surgery.
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I am fully active or restricted in physically strenuous activity but can do light work.

BRCA-P Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to the occurrence of any breast cancer (invasive or ductal carcinoma in situ [DCIS])
Secondary outcome measures
Assess incidence, nature and severity of adverse events (AEs) using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Frequency of benign breast lesions
Frequency of breast biopsies
+5 more

Side effects data

From 2022 Phase 4 trial • 37 Patients • NCT04026256
44%
joint pain
22%
nausea
22%
propagation of fracture at biopsy site
11%
dizziness
11%
rhinorrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Denosumab Only
Teriparatide Only
Denosumab and Teriparatide

BRCA-P Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm A (denosumab)Experimental Treatment2 Interventions
Patients receive denosumab SC q6m for up to 5 years in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (placebo)Placebo Group2 Interventions
Patients receive placebo SC q6m for up to 5 years in the absence of disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Denosumab
2013
Completed Phase 4
~12010

Find a Location

Who is running the clinical trial?

Austrian Breast & Colorectal Cancer Study Group (ABCSG)UNKNOWN
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,326 Total Patients Enrolled
74 Trials studying Breast Cancer
39,843 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,728 Previous Clinical Trials
40,965,691 Total Patients Enrolled
942 Trials studying Breast Cancer
1,543,680 Patients Enrolled for Breast Cancer

Media Library

Denosumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04711109 — Phase 3
Denosumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04711109 — Phase 3
Breast Cancer Research Study Groups: Arm A (denosumab), Arm B (placebo)
Breast Cancer Clinical Trial 2023: Denosumab Highlights & Side Effects. Trial Name: NCT04711109 — Phase 3
~200 spots leftby Jul 2027
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