BRCA1 MutationPhase 3BRCA-PNCT04711109
Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation
A Phase 3 study testing Denosumab and Quality-of-Life Assessment in people with BRCA1 Mutation and Breast Cancer, run by Alliance for Clinical Trials in Oncology at 47 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- BRCA1 Mutation, Breast Cancer, Breast Diseases
- What is being tested?
- Denosumab and Quality-of-Life Assessment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 47 sitesUnited States
- Study dates
- 14 Feb 2023to Dec 2033
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
United States47 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304
University of Vermont Medical Center
Burlington, Vermont, 05401
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, 80112
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204
Northwestern University
Chicago, Illinois, 60611
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, 80113
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado, 80113
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Novant Health Breast Surgery - Greensboro
Greensboro, North Carolina, 27403
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, 60035
M D Anderson Cancer Center
Houston, Texas, 77030
Novant Health Cancer Institute - Kernersville
Kernersville, North Carolina, 27284
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89148
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, 80120
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, 80124
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Novant Health Cancer Institute - Mount Airy
Mount Airy, North Carolina, 27030
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, 66211
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Regions Hospital
Saint Paul, Minnesota, 55101
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
UCSF Medical Center-Mount Zion
San Francisco, California, 94115
Maine Medical Center- Scarborough Campus
Scarborough, Maine, 04074
Maine Medical Partners - South Portland
South Portland, Maine, 04106
Novant Health Cancer Institute - Thomasville
Thomasville, North Carolina, 27360
Carle Cancer Center
Urbana, Illinois, 61801
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103
About this study
Official title: 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
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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
- BRCA1 Mutation, Breast Cancer, Breast Diseases, Breast Neoplasms, Breast Carcinoma, Neoplasms
- Being tested
- Denosumab, Placebo, Quality-of-Life Assessment
- Keywords
- RANKL, Breast Cancer Prevention, Denosumab, Bone Density Conservation Agents, Physiological Effects of Drugs
- Medical subject headings
- Breast Neoplasms, Breast Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabDrug
Given SC
PlaceboDrug
Given SC
Quality-of-Life AssessmentOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm A (denosumab) | Experimental | Patients receive denosumab SC q6m for up to 5 years in the absence of disease progression or unacceptable toxicity. Receives: Drug: Denosumab; Other: Quality-of-Life Assessment |
| Arm B (placebo) | Placebo comparator | Patients receive placebo SC q6m for up to 5 years in the absence of disease progression. Receives: Drug: Placebo; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the occurrence of any breast cancer (invasive or ductal carcinoma in situ [DCIS])
Time to breast cancer (invasive or DCIS) will be compared between the two treatment arms using a stratified Cox proportional hazards regression model.
Measured: From randomization to the occurrence of breast cancer (invasive or DCIS), assessed up to 5 years
Secondary outcomes (8)
Time to invasive breast cancer
Will be compared between the two treatment arms using a stratified Cox proportional hazards regression model.
Measured: Up to 5 years post treatment
Time to invasive triple negative breast cancer
Will be compared between the two treatment arms using a stratified Cox proportional hazards regression model.
Measured: Up to 5 years post treatment
Time to ovarian, fallopian and peritoneal cancer (in women who have not undergone prophylactic bilateral salpingo-oophorectomy)
Will be compared between the two treatment arms using a stratified Cox proportional hazards regression model. Time to ovarian cancer will be analyzed in the overall group and in different strata (oral contraceptive use, hormone replacement therapy use, and menopausal status).
Measured: Up to 5 years post treatment
Time to other (nonbreast or ovarian cancer) malignancies, including those known to be associated with BRCA1 mutations
Will be compared between the two treatment arms using a stratified Cox proportional hazards regression model.
Measured: Up to 5 years post treatment
Time to clinical fractures in pre- and postmenopausal women
Will be compared between the two treatment arms using a stratified Cox proportional hazards regression model.
Measured: Up to 5 years post treatment
Frequency of breast biopsies
May be recommended as part of care based on a finding on mammogram, MRI, ultrasound or physical exam performed as part of monitoring for breast cancer. Will be compared between the two treatment arms via chi-square analysis.
Measured: Up to 5 years post treatment
Frequency of benign breast lesions
May be recommended as part of care based on a finding on mammogram, MRI, ultrasound or physical exam performed as part of monitoring for breast cancer. Will be compared between the two treatment arms via chi-square analysis.
Measured: Up to 5 years post treatment
Assess incidence, nature and severity of adverse events (AEs) using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment will be reported per treatment arm.
Measured: Up to 5 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start14 Feb 2023
- Primary completionJul 2027 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRCA1 MutationStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Austrian Breast & Colorectal Cancer Study Group
- Responsible party
- Sponsor
- Investigators
- Judy E. Garber, MD, MPH, Study chair, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711109
- Sponsor's protocol ID
- A211801
- Other IDs
- NCI-2020-11358, UG1CA189823, 2017-002505-35, ABCSG 50, 2017
- Acronym
- BRCA-P
- Status last verified
- Oct 2026
- First submitted
- 13 Jan 2021
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04711109
- Acronym / sponsor ID
- BRCA-P / A211801
- Conditions
- BRCA1 Mutation, Breast Cancer, Breast Diseases, Breast Neoplasms, Breast Carcinoma, Neoplasms
- Keywords
- RANKL, Breast Cancer Prevention, Denosumab, Bone Density Conservation Agents, Physiological Effects of Drugs
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Austrian Breast & Colorectal Cancer Study Group
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (denosumab) | Experimental | Drug: Denosumab, Other: Quality-of-Life AssessmentPatients receive denosumab SC q6m for up to 5 years in the absence of disease progression or unacceptable toxicity. |
| Arm B (placebo) | Placebo comparator | Drug: Placebo, Other: Quality-of-Life AssessmentPatients receive placebo SC q6m for up to 5 years in the absence of disease progression. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DenosumabGiven SC | Drug | Arm A (denosumab) |
| PlaceboGiven SC | Drug | Arm B (placebo) |
| Quality-of-Life AssessmentAncillary studies | Other | Arm A (denosumab), Arm B (placebo) |
Primary outcome
Time to the occurrence of any breast cancer (invasive or ductal carcinoma in situ [DCIS])
Time frame: From randomization to the occurrence of breast cancer (invasive or DCIS), assessed up to 5 years
Time to breast cancer (invasive or DCIS) will be compared between the two treatment arms using a stratified Cox proportional hazards regression model.
8 secondary outcomes
Time to invasive breast cancer
Time frame: Up to 5 years post treatment
Time to invasive triple negative breast cancer
Time frame: Up to 5 years post treatment
Time to ovarian, fallopian and peritoneal cancer (in women who have not undergone prophylactic bilateral salpingo-oophorectomy)
Time frame: Up to 5 years post treatment
Time to other (nonbreast or ovarian cancer) malignancies, including those known to be associated with BRCA1 mutations
Time frame: Up to 5 years post treatment
Time to clinical fractures in pre- and postmenopausal women
Time frame: Up to 5 years post treatment
Frequency of breast biopsies
Time frame: Up to 5 years post treatment
Frequency of benign breast lesions
Time frame: Up to 5 years post treatment
Assess incidence, nature and severity of adverse events (AEs) using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time frame: Up to 5 years post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judy E. Garber, MD, MPH study chair
Dana-Farber Cancer Institute
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Denosumab and Quality-of-Life Assessment in people with BRCA1 Mutation and Breast Cancer, run by Alliance for Clinical Trials in Oncology at 47 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to the occurrence of any breast cancer (invasive or ductal carcinoma in situ [DCIS]) (time frame: From randomization to the occurrence of breast cancer (invasive or DCIS), assessed up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.