Denosumab for Breast Cancer Risk Reduction in Women With an Inherited BRCA1 Mutation (The Breast Cancer Prevention Study)

About the Study

The BRCA-P Study is an international research study for women who are born with a mutation (change) in one of their BRCA1 genes. The main purpose is to find out if the study medication, denosumab, can decrease the risk of developing breast cancer compared to a placebo (inactive substance) in women with a BRCA1 gene mutation.

Denosumab is a drug approved by the FDA for treating osteoporosis (weakening of the bones) in healthy people. It is also approved for serious bone problems in people who have cancer that has metastasized (spread) to the bone. Some common side effects of denosumab include muscle and bone pain, shortness of breath, and low levels of calcium and phosphate in the blood. If you choose to take part in this study, your study doctor will carefully decide if denosumab is right for you.

Type of Study:

BRCA-P is a double-blind, randomized, two-arm study to evaluate the effects of denosumab on reducing breast cancer risk.

• Double-blind means neither you nor your doctor will know in which group you will be placed.
• Randomized, two-arm means that if you consent to participate, a computer will assign you to one of the two study groups (“arms”): a denosumab group (1) or a placebo group (2). You will have a 50/50 chance of being in Group 1 or Group 2.

What the Study Involves

If you are eligible and decide to join the BRCA-P Study, you will be asked to:

• Have blood drawn once a year while you are on study for testing and research (up to 4 tablespoons)
• Be given a small injection of denosumab or placebo (inactive substance) under the skin every 6 months for 5 years
• Provide a copy of your mammogram when you enroll and after your first year in the study for the study team to evaluate your breast density
• Have regular follow-ups with your study doctor/medical team to check on your overall health and talk about any symptoms or side effects
• Follow up with your study doctor yearly for up to 5 years after your last injection of denosumab or placebo
• Have a dental exam to make sure you don’t have any infections in your mouth (denosumab can cause some dental side effects, which are especially severe in women with an active mouth infection). If dental concerns are found, you may be asked to visit your dentist before enrolling in the study.
• As recommended by the study, take calcium (500 mg) and vitamin D (400 IU) supplements daily for 5 years. Calcium and vitamin D are recommended for general bone health, and particularly for those taking denosumab.

You may also be asked to consider some optional studies (sub-studies). If you join a sub-study, you may be asked to:

• Fill out some “quality of life” surveys that are especially important for learning about your well-being and any unexpected side effects
• Give blood for research purposes
• Take a new bone density test that is highly sensitive to changes in bones

Note: We highly recommend undergoing a dental exam before you join the study and taking calcium and vitamin D supplements while you are on the study. The study does not cover the costs of dental care and supplements. Please speak to your doctor if this presents a hardship to you.

Study Sites

California

• Los Angeles, CA
  University of Southern California, Norris Comprehensive Cancer Center
  1441 Eastlake Avenue
  Site Lead: Darcy Spicer, MD
  Contact: [email protected]
• San Francisco, CA
  University of California San Francisco - Mount Zion
  1600 Divisadero Street
  Site Lead: Pamela Munster, MD PhD
  Contact: [email protected]

Colorado

• Aurora, CO
  University of Colorado
  1635 Aurora Court
  Site Lead: Marie Wood, MD
  Contact: [email protected]

• Denver, CO
  Rocky Mountain Cancer Centers 4700 East Hale Parkway
  Suite 400
  Site Lead: Nicholas DiBella, MD
  Contact: [email protected]

District of Columbia

• Washington, DC
  Georgetown University Hospital
  3800 Reservoir Road Northwest
  Site Leads: Claudine Isaacs, MD; Lucile L. Adams-Campbell MD
  Contact: [email protected]

Illinois

• Chicago, IL
  Northwestern University Hospital
  303 East Chicago Avenue
  Site Lead: Seema Khan, MD
  Contact: [email protected]
• Chicago, IL
  University of Chicago
  5841 S. Maryland Ave MC 2115
  Site Lead: Funmi Olopade, MD
  Contact: [email protected]
• Evanston, IL
  Northshore University Health System
  2650 Ridge Avenue
  Site Lead: Katharine Yao, MD
  Contact: [email protected]
• Urbana, IL
  Carle Cancer Center
  Contact: 800-446-5532 or by email at: [email protected]       
  Lead Researcher:  Kendrith M. Rowland     

Kansas

• Westwood, KS
  University of Kansas Cancer Center
  2330 Shawnee Mission Parkway Suite 1102
  Site Lead: Lauren Nye, MD
  Contact: [email protected]

Massachusetts

• Boston, MA
  Dana-Farber Cancer Institute
  450 Brookline Ave
  Site Lead: Judy E. Garber, MD MPH
  Contact: [email protected]
• Boston, MA
  Beth Israel Deaconess Medical Center
  330 Brookline Ave
  Site Lead: Dr. Nadine Tung
  Contact: [email protected]

Maryland

• Baltimore, MD
• Johns Hopkins University
  600 North Wolfe Street
  Site Lead: Kala Visvanathan, MD
  Contact: [email protected]

Maine

• South Portland, ME
  Maine Medical Center Research Institute
  265 Western Avenue
  Site Lead: Susan Miesfeldt, MD
  Contact: [email protected]

Michigan

• Ann Arbor, MI
  University of Michigan, Rogel Cancer Center
  1500 East Medical Center Drive
  Site Leads: Versha Pleasant, MD
  Contact: [email protected]
• Grand Rapids, MI
  Spectrum Health at Butterworth Campus
  100 Michigan St NE, MC012
  Site Lead: Kathleen J. Yost, MD
  Contact: [email protected]

Minnesota

• Rochester, MN
  Mayo Clinic in Rochester
  Contact: Site Public Contact 855-776-0015
  Lead Researcher: Sandhya Pruthi  
  Contact: [email protected]       
• Saint Paul, MN
  Regions Hospital 640 Jackson Street
  Lead: Daniel Anderson, MD, MPH
  Contact: [email protected]

Nevada

• Las Vegas, NV
  OptumCare Cancer Care at Fort Apache 6190 South Fort Apache Road
  Site Lead: John Ellerton, MD, CM
  Contact: [email protected]

New York

• New York, NY
  Columbia University
  630 West 168th Street
  Site Leads: Gary K. Schwartz, MD, Katherine Crew, MD
  Contact: [email protected]
• New York, NY
  Memorial Sloan Kettering Cancer Center
  1275 York Avenue
  Site Lead: Mark Robson, MD
  Contact: [email protected]

North Carolina

• Charlotte, NC
  Novant Health Presbyterian Medical Center 200 Hawthorne Ln
  Site Lead: Dr. Judith Hopkins MD
  Contact: [email protected]

North Dakota

• Fargo, ND
  Sanford Roger Maris Cancer Center
  Lead Researcher: Preston D. Steen
  Contact: Site Public Contact: 701-234-6161 or by email at: [email protected]    

Ohio

• Columbus, OH
  The Ohio State University
  James Cancer Hospital Solove Research Institute
  460 W 10th Ave
  Site Lead: Sagar Sardesai MD
  Contact: [email protected]

Pennsylvania

• Philadelphia, PA
  University of Pennsylvania
  The Basser Center for BRCA
  3400 Civic Center Boulevard
  Site Lead: Susan Domchek, MD
  Contact: [email protected]
• Pittsburgh, PA
  University of Pittsburgh
  5115 Centre Avenue
  Site Lead: Phuong Mai, MD
  Contact: [email protected]

South Carolina

• Spartanburg, SC Gibbs
  Cancer Center and Research Institute
  101 E. Wood St.
  Site Lead: Amanda Hathaway, MD
  Contact: [email protected]   

Texas

• Dallas, TX
  University of Texas, Southwestern Medical Center
  5323 Harry Hines Blvd.
  Site Lead: Rachel Wooldridge, MD
  Contact: [email protected]
• Houston, TX
  The University of Texas, MD Anderson Cancer Center 515 Holcombe Blvd.
  Site Leads: Banu Arun, MD; Isabelle Bedrosian, MD
  Contact: [email protected]
• Houston, TX
  M D Anderson Cancer Center
  Lead Researcher: Isabelle Bedrosian
  Contact: Site Public Contact: 877-632-6789 or by email at: [email protected]

Utah

• Salt Lake City, UT
  University of Utah
  Huntsman Cancer Institute
  2000 Circle of Hope Dr. #1950
  Site Lead: Sarah Colonna, MD
  Contact: [email protected]

Virginia

• Richmond, VA
  Virginia Commonwealth University
  Massey Cancer Center
  401 College Street
  Site Lead: Masey Ross, MD
  Contact: [email protected]      

You may be eligible to participate in the BRCA-P Study if you:

• Are a woman who has a confirmed BRCA1 gene mutation (variant) 
• Are 25 to 55 years old Do NOT have a history of breast or ovarian cancer 
• Are not pregnant or breastfeeding
• Have not had a mastectomy (removal of breast(s) by surgery)

We encourage women of all racial and ethnic groups to participate in this study so that it fully represents all populations affected by BRCA1 mutations.

 

The study is not open to people assigned at birth as male.

The study is not open to women:

• who have had a prior bilateral mastectomy.
• who have a history of breast or ovarian cancer (including fallopian and peritoneal cancer).    
• who use any of the following medications: 
  • denosumab.
  • tamoxifen, raloxifene or aromatase inhibitor during the last 3 months prior to joining the study, or for a duration of more than 3 years in total.
  • Current treatment with a bisphosphonate or an anti-angiogenic agent.
• who have an active infection with hepatitis B virus or hepatitis C virus.
• who have human immunodeficiency virus (HIV).
• who have a diagnosis of dental or jaw condition such as osteonecrosis or osteomyelitis, or a condition that requires oral. surgery within 3 months of joining the study.