Status:
ACTIVE_NOT_RECRUITING
Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Austrian Breast & Colorectal Cancer Study Group (ABCSG)
Conditions:
BRCA1 Mutation
Breast Cancer
Eligibility:
FEMALE
25-55 years
Phase:
PHASE3
Brief 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...
Detailed Description
PRIMARY OBJECTIVE: 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 c...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2033
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04711109
Start Date
February 14 2023
End Date
December 1 2033
Last Update
April 2 2025
Active Locations (47)
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1
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
2
UCSF Medical Center-Mount Zion
San Francisco, California, United States, 94115
3
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, United States, 80012
4
UCHealth University of Colorado Hospital
Aurora, Colorado, United States, 80045