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BRCA-P: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, International Phase 3 Study to Determine the Preventive Effect of Denosumab on Breast Cancer in Women Carrying a BRCA1 Germline Mutation

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513734-38-00
Acronym
BRCA-P/ABCSG 50
Enrollment
1150
Registered
2024-08-14
Start date
2019-07-03
Completion date
Unknown
Last updated
2025-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of breast cancer in women with a BRCA1 germline mutation

Brief summary

Time to the occurrence of any breast cancer (invasive or DCIS)

Detailed description

Time to invasive breast cancer, Time to invasive triple negative breast cancer, Time to ovarian, fallopian tube or primary peritoneal cancer (in women who have not undergone PBSO), Time to other (non breast or ovarian cancer) malignancies, including those known to be associated with BRCA1 mutations, Time to clinical fractures in pre- and postmenopausal women, Frequency of breast biopsies and frequency of benign breast lesions

Interventions

DRUGIdentical to the Test product

Sponsors

Verein Zur Praevention Und Therapie Boesartiger Erkrankungen Austrian Breast And Colorectal Cancer Study Group, Institut Catala D'oncologia, ANZ Breast Cancer Trials Group Limited, University Of Manchester, Alliance Foundation Trials LLC, Shaare Zedek Medical Center
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Time to the occurrence of any breast cancer (invasive or DCIS)

Secondary

MeasureTime frame
Time to invasive breast cancer, Time to invasive triple negative breast cancer, Time to ovarian, fallopian tube or primary peritoneal cancer (in women who have not undergone PBSO), Time to other (non breast or ovarian cancer) malignancies, including those known to be associated with BRCA1 mutations, Time to clinical fractures in pre- and postmenopausal women, Frequency of breast biopsies and frequency of benign breast lesions

Countries

Austria, Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026