Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation
NCT ID: NCT04711109
Last Updated: 2025-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2023-02-14
2033-12-31
Brief Summary
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Detailed Description
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I. To evaluate the reduction in the risk of any breast cancer (invasive or ductal carcinoma in situ \[DCIS\]) in women with germline BRCA1 mutation who are treated with denosumab compared to placebo.
SECONDARY OBJECTIVES:
I. To determine the reduction in the risk of invasive breast cancer in women with germline BRCA1 mutation who are treated with denosumab compared to placebo.
II. To determine the reduction in the risk of invasive triple negative breast cancer (TNBC) in women with germline BRCA1 mutation who are treated with denosumab compared to placebo.
III. To determine the reduction in risk of ovarian, fallopian and peritoneal cancers (in women who have not undergone prophylactic bilateral salpingo-oophorectomy \[PBSO\]) in women with germline BRCA1 mutation who are treated with denosumab compared to placebo.
IV. To determine the reduction in risk of other (i.e. non-breast and nonovarian) malignancies, including those known to be associated with BRCA1 germline mutations in women with germline BRCA1 mutation who are treated with denosumab compared to placebo.
V. To determine the reduction in the risk of clinical fractures in pre- and postmenopausal women with germline BRCA1 mutation who are treated with denosumab compared to placebo.
VI. To compare rates of breast biopsies and rate of benign breast lesions in women with germline BRCA1 mutation who are treated with denosumab compared to placebo.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive denosumab subcutaneously (SC) every 6 months (q6m) for up to 5 years in the absence of the development of breast cancer or unacceptable toxicity.
ARM B: Patients receive placebo SC q6m for up to 5 years in the absence of the development of breast cancer.
After completion of study treatment, patients are followed up every 12 months for 5 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Arm A (denosumab)
Patients receive denosumab SC q6m for up to 5 years in the absence of disease progression or unacceptable toxicity.
Denosumab
Given SC
Quality-of-Life Assessment
Ancillary studies
Arm B (placebo)
Patients receive placebo SC q6m for up to 5 years in the absence of disease progression.
Placebo
Given SC
Quality-of-Life Assessment
Ancillary studies
Interventions
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Denosumab
Given SC
Placebo
Given SC
Quality-of-Life Assessment
Ancillary studies
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
25 Years
55 Years
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Austrian Breast & Colorectal Cancer Study Group (ABCSG)
UNKNOWN
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Judy E. Garber, MD, MPH
Role: STUDY_CHAIR
Dana-Farber Cancer Institute
Locations
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USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCSF Medical Center-Mount Zion
San Francisco, California, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, United States
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, United States
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
Maine Medical Center- Scarborough Campus
Scarborough, Maine, United States
Maine Medical Partners - South Portland
South Portland, Maine, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
Novant Health Breast Surgery - Greensboro
Greensboro, North Carolina, United States
Novant Health Cancer Institute - Kernersville
Kernersville, North Carolina, United States
Novant Health Cancer Institute - Mount Airy
Mount Airy, North Carolina, United States
Novant Health Cancer Institute - Thomasville
Thomasville, North Carolina, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
Countries
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Other Identifiers
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NCI-2020-11358
Identifier Type: REGISTRY
Identifier Source: secondary_id
2017-002505-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ABCSG 50
Identifier Type: OTHER
Identifier Source: secondary_id
A211801
Identifier Type: -
Identifier Source: org_study_id
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