Breast Cancer Prevention in Women with BRCA-P mutation

Study Overview

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.

Trial identification number

NCT04711109

The medicine(s) being studied.

Denosumab OR Placebo (sugar pill)

How does the new medicine work (Mechanism of Action)?

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.

What will be evaluated (Key endpoints)?

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.

Who may participate (Inclusion criteria)?
  • Healthy female volunteers
  • Women with a confirmed BRCA 1 germline mutation (variant class 4 or 5)
  • Age 25-55 years
  • No history or evidence of breast or ovarian cancer
  • Not pregnant
  • No plans a preventive mastectomy
  • Good health status
  • Able and willing to provide written informed consent

Who may not participate (Exclusion criteria)?
  • Existing cancer, mastectomy, pregnancy, or risk factors for Denosumab.

List of participating clinical trials sites

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 clinicaltrials.gov