Ireland
--:--IST
Latest
Clinical Trials in Israel / NCT04711109
Active, not recruiting Phase 3

Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation

NCT04711109 · tracked via the Priya Life Science Israel tracker
Phase
Phase 3
Started
2023-02-14
Last updated
2025-04-02

Condition(s) studied

BRCA1 MutationBreast CancerBreast DiseasesBreast NeoplasmsBreast CarcinomaNeoplasms

Investigational drug(s) / intervention(s)

Denosumab →PlaceboQuality-of-Life Assessment

Denosumab: Given SC

Placebo: Given SC

Quality-of-Life Assessment: Ancillary studies

Study summary

This phase III trial compares denosumab to placebo for the prevention of breast cancer in women with a BRCA1 germline mutation. A germline mutation is an inherited gene change which, in the BRCA1 gene, is associated with an increased risk of breast and other cancers. Denosumab is a monoclonal antibody that is used to treat bone loss in order to reduce the risk of bone fractures in healthy people, and to reduce new bone growths in cancer patients whose cancer has spread to their bones. Research has shown that denosumab may also reduce the risk of developing breast cancer in women carrying a BRCA1 germline mutation.

Eligibility

Sex
FEMALE
Min age
25 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion 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 mammography (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 Exclusion Criteria: * Prior bilateral mastectomy * History of ovarian cancer (including fallopian and peritoneal cancer) * History of breast cancer * History of invasive cancer except for basal cell or squamous cell skin cancer or 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. (Note: Women of childbearing potential should be monitored for pregnancy prior to each denosumab/placebo injection) * Clinically relevant hypocalcemia (history and current condition), or serum calcium \< 2.0 mmol/L (\< 8.0 mg/dL) \* 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 subject). Monitoring of calcium level in regular intervals (usually prior to investigational product \[IP\] 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 hormone replacement therapy \[HRT\] is permitted) * Prior use of denosumab * Subject 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 within 3 months of enrollment * Concurrent treatment with a bisphosphonate or an anti-angiogenic agent * Any major medical or psychiatric condition that may prevent the subject from completing the study * Known active infection with hepatitis B virus or hepatitis C virus * Known infection with human immunodeficiency virus (HIV) * Use of any other investigational product (current or prior aspirin or non-steroidal anti-inflammatory drugs \[NSAIDs\] are permitted)

Primary outcome measure(s)

Trial sites (47)

FacilityCityRegionStatus
USC / Norris Comprehensive Cancer Center Los Angeles California
UCSF Medical Center-Mount Zion San Francisco California
Rocky Mountain Cancer Centers-Aurora Aurora Colorado
UCHealth University of Colorado Hospital Aurora Colorado
Rocky Mountain Cancer Centers-Boulder Boulder Colorado
Rocky Mountain Cancer Centers - Centennial Centennial Colorado
Rocky Mountain Cancer Centers-Midtown Denver Colorado
Rocky Mountain Cancer Centers-Rose Denver Colorado
Mountain Blue Cancer Care Center - Swedish Englewood Colorado
Rocky Mountain Cancer Centers - Swedish Englewood Colorado
Rocky Mountain Cancer Centers-Littleton Littleton Colorado
Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado
MedStar Georgetown University Hospital Washington D.C. District of Columbia
Northwestern University Chicago Illinois
University of Chicago Comprehensive Cancer Center Chicago Illinois
NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois
Carle Cancer Center Urbana Illinois
University of Kansas Hospital-Indian Creek Campus Overland Park Kansas
University of Kansas Hospital-Westwood Cancer Center Westwood Kansas
Maine Medical Center- Scarborough Campus Scarborough Maine
Maine Medical Partners - South Portland South Portland Maine
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland
Beth Israel Deaconess Medical Center Boston Massachusetts
Dana-Farber Cancer Institute Boston Massachusetts
University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids Michigan
Mayo Clinic in Rochester Rochester Minnesota
Regions Hospital Saint Paul Minnesota
OptumCare Cancer Care at Fort Apache Las Vegas Nevada
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York
Memorial Sloan Kettering Cancer Center New York New York
Novant Health Presbyterian Medical Center Charlotte North Carolina
Novant Health Breast Surgery - Greensboro Greensboro North Carolina
Novant Health Cancer Institute - Kernersville Kernersville North Carolina
Novant Health Cancer Institute - Mount Airy Mount Airy North Carolina
Novant Health Cancer Institute - Thomasville Thomasville North Carolina
Novant Health Forsyth Medical Center Winston-Salem North Carolina
Sanford Roger Maris Cancer Center Fargo North Dakota
Ohio State University Comprehensive Cancer Center Columbus Ohio

+ 7 more sites — see the full list on the official registry below.

More Alliance for Clinical Trials in Oncology trials in Israel

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04711109 on ClinicalTrials.gov ↗ ← All trials in Israel