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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

February 14, 2023

Primary Completion Date

July 31, 2027

Study Completion Date

December 31, 2033

Conditions
BRCA1 MutationBreast CancerBreast DiseasesBreast NeoplasmsBreast CarcinomaNeoplasms
Interventions
DRUG

Denosumab

Given SC

DRUG

Placebo

Given SC

OTHER

Quality-of-Life Assessment

Ancillary studies

Trial Locations (47)

10032

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York

10065

Memorial Sloan Kettering Cancer Center, New York

15232

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh

19104

University of Pennsylvania/Abramson Cancer Center, Philadelphia

20007

MedStar Georgetown University Hospital, Washington D.C.

21287

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

23298

Virginia Commonwealth University/Massey Cancer Center, Richmond

27030

Novant Health Cancer Institute - Mount Airy, Mount Airy

27103

Novant Health Forsyth Medical Center, Winston-Salem

27284

Novant Health Cancer Institute - Kernersville, Kernersville

27360

Novant Health Cancer Institute - Thomasville, Thomasville

27403

Novant Health Breast Surgery - Greensboro, Greensboro

28204

Novant Health Presbyterian Medical Center, Charlotte

43210

Ohio State University Comprehensive Cancer Center, Columbus

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

49503

Corewell Health Grand Rapids Hospitals - Butterworth Hospital, Grand Rapids

55101

Regions Hospital, Saint Paul

55905

Mayo Clinic in Rochester, Rochester

58122

Sanford Roger Maris Cancer Center, Fargo

60035

NorthShore University HealthSystem-Highland Park Hospital, Highland Park

60201

NorthShore University HealthSystem-Evanston Hospital, Evanston

60611

Northwestern University, Chicago

60637

University of Chicago Comprehensive Cancer Center, Chicago

61801

Carle Cancer Center, Urbana

66205

University of Kansas Hospital-Westwood Cancer Center, Westwood

66211

University of Kansas Hospital-Indian Creek Campus, Overland Park

75390

UT Southwestern/Simmons Cancer Center-Dallas, Dallas

77030

M D Anderson Cancer Center, Houston

80012

Rocky Mountain Cancer Centers-Aurora, Aurora

80045

UCHealth University of Colorado Hospital, Aurora

80112

Rocky Mountain Cancer Centers - Centennial, Centennial

80113

Mountain Blue Cancer Care Center - Swedish, Englewood

Rocky Mountain Cancer Centers - Swedish, Englewood

80120

Rocky Mountain Cancer Centers-Littleton, Littleton

80124

Rocky Mountain Cancer Centers-Sky Ridge, Lone Tree

80218

Rocky Mountain Cancer Centers-Midtown, Denver

80220

Rocky Mountain Cancer Centers-Rose, Denver

80304

Rocky Mountain Cancer Centers-Boulder, Boulder

84112

Huntsman Cancer Institute/University of Utah, Salt Lake City

89148

OptumCare Cancer Care at Fort Apache, Las Vegas

90033

USC / Norris Comprehensive Cancer Center, Los Angeles

94115

UCSF Medical Center-Mount Zion, San Francisco

04074

Maine Medical Center- Scarborough Campus, Scarborough

04106

Maine Medical Partners - South Portland, South Portland

02215

Beth Israel Deaconess Medical Center, Boston

Dana-Farber Cancer Institute, Boston

05401

University of Vermont Medical Center, Burlington

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Austrian Breast & Colorectal Cancer Study Group (ABCSG)

UNKNOWN

lead

Alliance for Clinical Trials in Oncology

OTHER

NCT04711109 - Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation | Biotech Hunter | Biotech Hunter