Breast Cancer Prevention in Women with BRCA-P mutation
Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation (BRCA-P)
This clinical trial is testing if a medicine called denosumab can prevent breast cancer in women who have a specific inherited gene change known as BRCA1 germline mutation. Women with this gene change have a higher chance of getting breast and other types of cancer.
Denosumab is usually used to treat bone loss to lower the risk of bone breaks in healthy people. Early studies suggest that denosumab might also help in reducing the chance of developing breast cancer in women with the BRCA1 gene change.
In this trial, denosumab is being compared to a placebo, which is a treatment that looks like the medicine but has no active ingredients, to see if it is effective in preventing breast cancer.
NCT04711109
Denosumab OR Placebo (sugar pill)
Denosumab is a medicine that is currently used in women to prevent bone loss.
Inside your body, there's a substance called RANK Ligand which affects how bone cells behave. If there's too much RANK Ligand, it can cause your body to break down bone faster than it should, leading to weaker bones.
Denosumab works by sticking to the RANK Ligand. By doing this, it helps slow down the process that leads to bone loss, keeping your bones stronger for longer.
Connection to Breast Cancer: Recent research has suggested that RANK ligand might also be involved in the development of breast cancer, especially in individuals with BRCA1 mutations. BRCA1 mutations are known to significantly increase the risk of breast and ovarian cancers.
Why It's Relevant: The BRCA1 gene normally helps to suppress tumor growth. When it's mutated, this protective effect is lost, increasing cancer risk. RANK ligand has been identified as a potential factor in this process because it might influence the development of mammary cells in a way that could lead to cancer, particularly in the context of a BRCA1 mutation.
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 compared to placebo.
People without lung cancer history, showing lung nodules with a 10-30% chance of being cancerous, based on specific predictions.
Those with lung nodules over 30% chance of being cancerous but confirmed not malignant through biopsy.
Individuals with a history of early-stage lung cancer, who've completed treatment, showing persistent lung nodules.
Criteria for eligibility include being 18 or older, agreeing to specific contraceptive measures, providing informed consent, having a certain health status, and meeting organ function requirements as outlined.
Existing cancer, mastectomy, pregnancy, or risk factors for Denosumab.
California Locations
Los Angeles, California, United States, 90033
USC / Norris Comprehensive Cancer Center
Contact:
Site Public Contact
323-865-0451
Principal Investigator:
Darcy V. Spicer
San Francisco, California, United States, 94115
UCSF Medical Center-Mount Zion
Contact:
Site Public Contact
877-827-3222
Principal Investigator:
Pamela N. Munster
Colorado Locations
Aurora, Colorado, United States, 80045
Recruiting
UCHealth University of Colorado Hospital
Contact:
Site Public Contact
720-848-0650
Principal Investigator:
Marie E. Wood
Denver,Colorado, United States, 80220
RockyMountain Cancer Centers-Rose
Contact:
SitePublic Contact
303-777-2663 info@westernstatesncorp.org
PrincipalInvestigator:
NicholasDiBella
District of Columbia Locations
Washington, District of Columbia, United States, 20007
MedStar Georgetown University Hospital
Contact:
Site Public Contact
202-444-2223
Principal Investigator:
Claudine Isaacs
Illinois Locations
Chicago, Illinois, United States, 60611
Northwestern University
Contact:
Site Public Contact
312-695-1301 cancer@northwestern.edu
Principal Investigator:
Seema A. Khan
Evanston, Illinois, United States, 60201
NorthShore University HealthSystem-Evanston Hospital
Contact:
Site Public Contact
847-570-2109
Principal Investigator:
Katharine A. Yao
Urbana, Illinois, United States, 61801
Carle Cancer Center
Contact:
Site Public Contact
800-446-5532 Research@carle.com
Principal Investigator:
Kendrith M. Rowland
Kansas Locations
Westwood, Kansas, United States, 66205
University of Kansas Hospital-Westwood Cancer Center
Contact:
Site Public Contact
913-588-3671 KUCC_Navigation@kumc.edu
Principal Investigator:
Lauren Nye
Maine Locations
South Portland, Maine, United States, 04106
Maine Medical Partners - South Portland
Contact:
Site Public Contact
207-396-8670 ClinicalResearch@mmc.org
Principal Investigator:
Susan Miesfeldt
Massachusetts Locations
Boston, Massachusetts, United States, 02215
Beth Israel Deaconess Medical Center
Contact:
Site Public Contact
617-667-9925
Principal Investigator:
Nadine M. Tung
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Contact:
Site Public Contact
877-442-3324
Principal Investigator:
Judy E. Garber
Michigan Locations
Ann Arbor, Michigan, United States, 48109
University of Michigan Comprehensive Cancer Center
Contact:
Site Public Contact
800-865-1125
Principal Investigator:
Melissa L. Pilewskie
GrandRapids, Michigan, United States, 49503
SpectrumHealth at Butterworth Campus
Contact:
SitePublic Contact
616-391-1230 crcwm-regulatory@crcwm.org
PrincipalInvestigator:
KathleenJ. Yost
Minnesota Locations
Rochester, Minnesota, United States, 55905
Mayo Clinic in Rochester
Contact:
Site Public Contact
855-776-0015
Principal Investigator:
Sandhya Pruthi
Saint Paul, Minnesota, United States, 55101
Regions Hospital
Contact:
Site Public Contact
952-993-1517 mmcorc@healthpartners.com
Principal Investigator:
Daniel M. Anderson
Nevada Locations
Las Vegas, Nevada, United States, 89148
OptumCare Cancer Care at Fort Apache
Contact:
Site Public Contact
702-384-0013 research@sncrf.org
Principal Investigator:
John A. Ellerton
New York Locations
New York, New York, United States, 10032
NYP/Columbia University Medical Center/Herbert IrvingComprehensive Cancer Center
Contact:
Site Public Contact
212-305-6361 nr2616@cumc.columbia.edu
Principal Investigator:
Katherine D. Crew
North Carolina Locations
Charlotte,North Carolina, United States, 28204
NovantHealth Presbyterian Medical Center
Contact:
SitePublic Contact
980-201-6360 kashah@novanthealth.org
PrincipalInvestigator:
LoriF. Gentile
Winston-Salem, North Carolina, United States, 27103
Novant Health Forsyth Medical Center
Contact:
Site Public Contact
336-718-8335 asmarrs@novanthealth.org
Principal Investigator:
Judith O. Hopkins
North Dakota Locations
Fargo, North Dakota, United States, 58122
Sanford Roger Maris Cancer Center
Ohio Locations
Columbus, Ohio, United States, 43210
Ohio State University Comprehensive Cancer Center
Contact:
Site Public Contact
800-293-5066 Jamesline@osumc.edu
Principal Investigator:
Sagar D. Sardesai
Pennsylvania Locations
Philadelphia, Pennsylvania, United States, 19104
University of Pennsylvania/Abramson Cancer Center
Contact:
Site Public Contact
800-474-9892
Principal Investigator:
Susan M. Domchek
Pittsburgh, Pennsylvania, United States, 15232
University of Pittsburgh Cancer Institute (UPCI)
Contact:
Site Public Contact
412-647-8073
Principal Investigator:
Phuong L. Mai
Texas Locations
Dallas, Texas, United States, 75390
UT Southwestern/Simmons Cancer Center-Dallas
Contact:
Site Public Contact
214-648-7097 canceranswerline@UTSouthwestern.edu
Principal Investigator:
Rachel D. Wooldridge
Houston, Texas, United States, 77030
M D Anderson Cancer Center
Contact:
Site Public Contact
877-632-6789 askmdanderson@mdanderson.org
Principal Investigator:
Isabelle Bedrosian
Utah Locations
Salt Lake City, Utah, United States, 84112
Huntsman Cancer Institute/University of Utah
Contact:
Site Public Contact
888-424-2100 cancerinfo@hci.utah.edu
Principal Investigator:
Sarah V. Colonna
Virginia Locations
Richmond, Virginia, United States, 23298
Virginia Commonwealth University/Massey Cancer Center
Contact:
Site Public Contact
CTOclinops@vcu.edu
Principal Investigator:
Masey M. Ross
Any other information
Link to clinicaltrails.gov