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

Clinicaltrials.gov identifier:
NCT04711109

Prevention
Prevention study enrolling women ages 25-55 with a BRCA1 mutation

Study Contact Information:

For additional information, please contact::
Judy E. Garber, MD, MPH: (617) 632-5961 or by email: judy_garber@dfci.harvard.edu

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 genes. The main purpose is to find out if the study medication, denosumab, can decrease the risk of developing breast cancer compared to a (inactive substance) in women with a gene mutation.

Denosumab is a drug approved by the for treating (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, , 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.
  • , 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 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 (inactive substance) under the skin every 6 months for 5 years
  • Provide a copy of your 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
  • 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: dspicer@med.usc.edu
  • San Francisco, CA
    University of California San Francisco - Mount Zion
    1600 Divisadero Street
    Site Lead: Pamela Munster, MD PhD
    Contact: pamela.munster@ucsf.edu

Colorado

District of Columbia

  • Washington, DC
    Georgetown University Hospital
    3800 Reservoir Road Northwest
    Site Leads: Claudine Isaacs, MD; Lucile L. Adams-Campbell MD
    Contact: isaacsc@georgetown.edu

Illinois

  • Chicago, IL
    Northwestern University Hospital
    303 East Chicago Avenue
    Site Lead: Seema Khan, MD
    Contact: s-khan2@northwestern.edu
  • Chicago, IL
    University of Chicago
    5841 S. Maryland Ave MC 2115
    Site Lead: Funmi Olopade, MD
    Contact: folopade@bsd.uchicago.edu
  • Evanston, IL
    Northshore University Health System
    2650 Ridge Avenue
    Site Lead: Katharine Yao, MD
    Contact: kyao@northshore.org
  • Urbana, IL
    Carle Cancer Center
    Contact: 800-446-5532 or by email at: Research@carle.com       
    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: lnye@kumc.edu

Massachusetts

  • Boston, MA
    Dana-Farber Cancer Institute
    450 Brookline Ave
    Site Lead: Judy E. Garber, MD MPH
    Contact: Judy_garber@dfci.harvard.edu
  • Boston, MA
    Beth Israel Deaconess Medical Center
    330 Brookline Ave
    Site Lead: Dr. Nadine Tung
    Contact: ntung@bidmc.harvard.edu

Maryland

  • Baltimore, MD
  • Johns Hopkins University
    600 North Wolfe Street
    Site Lead: Kala Visvanathan, MD
    Contact: kvisvan1@jhu.edu

Maine

Michigan

  • Ann Arbor, MI
    University of Michigan, Rogel Cancer Center
    1500 East Medical Center Drive
    Site Leads: Versha Pleasant, MD
    Contact: vershap@med.umich.edu
  • Grand Rapids, MI
    Spectrum Health at Butterworth Campus
    100 Michigan St NE, MC012
    Site Lead: Kathleen J. Yost, MD
    Contact: kyost@chcwm.com

Minnesota

Nevada

  • Las Vegas, NV
    OptumCare Cancer Care at Fort Apache 6190 South Fort Apache Road
    Site Lead: John Ellerton, MD, CM
    Contact: jaellerton@gmail.com

New York

  • New York, NY
    Columbia University
    630 West 168th Street
    Site Leads: Gary K. Schwartz, MD, Katherine Crew, MD
    Contact: kd59@cumc.columbia.edu
  • New York, NY
    Memorial Sloan Kettering Cancer Center
    1275 York Avenue
    Site Lead: Mark Robson, MD
    Contact: robsonm@mskcc.org

North Carolina

  • Charlotte, NC
    Novant Health Presbyterian Medical Center 200 Hawthorne Ln
    Site Lead: Dr. Judith Hopkins MD
    Contact: johopkins@novanthealth.org

North Dakota

Ohio

  • Columbus, OH
    The Ohio State University
    James Cancer Hospital Solove Research Institute
    460 W 10th Ave
    Site Lead: Sagar Sardesai MD
    Contact: sagar.sardesai@osumc.edu

Pennsylvania

  • Philadelphia, PA
    University of Pennsylvania
    The Basser Center for
    3400 Civic Center Boulevard
    Site Lead: Susan Domchek, MD
    Contact: susan.domchek@pennmedicine.upenn.edu
  • Pittsburgh, PA
    University of Pittsburgh
    5115 Centre Avenue
    Site Lead: Phuong Mai, MD
    Contact: maip@upmc.edu

South Carolina

  • Spartanburg, SC Gibbs
    Cancer Center and Research Institute
    101 E. Wood St.
    Site Lead: Amanda Hathaway, MD
    Contact: llugo@gibbscc.org   

Texas

  • Dallas, TX
    University of Texas, Southwestern Medical Center
    5323 Harry Hines Blvd.
    Site Lead: Rachel Wooldridge, MD
    Contact: rachel.wooldridge@utsouthwestern.edu
  • Houston, TX
    The University of Texas, MD Anderson Cancer Center 515 Holcombe Blvd.
    Site Leads: Banu Arun, MD; Isabelle Bedrosian, MD
    Contact: ibedrosian@mdanderson.org
  • Houston, TX
    M D Anderson Cancer Center
    Lead Researcher: Isabelle Bedrosian
    Contact: Site Public Contact: 877-632-6789 or by email at: askmdanderson@mdanderson.org

Utah

  • Salt Lake City, UT
    University of Utah
    Huntsman Cancer Institute
    2000 Circle of Hope Dr. #1950
    Site Lead: Sarah Colonna, MD
    Contact: sarah.colonna@hci.utah.edu

Virginia

  • Richmond, VA
    Virginia Commonwealth University
    Massey Cancer Center
    401 College Street
    Site Lead: Masey Ross, MD
    Contact: masey.ross@vcuhealth.org      
This Study is Open To:

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

  • Are a woman who has a confirmed 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 mutations.

 

This Study is Not Open To:

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

The study is not open to women:

  • who have had a prior 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.