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Denosumab in BRCA1 or BRCA2 Mutation Carriers Scheduling Risk-Reducing Salpingo-Oophorectomy

Denosumab in BRCA1 or BRCA2 Mutation Carriers Scheduling Risk-Reducing Salpingo-Oophorectomy

Clinicaltrials.gov identifier:
NCT03382574

Prevention:
Ovarian

Study Contact Information:

Contact: Dr. Meghna S. Trivedi by phone: 212-305-1945  or by email  


Pilot Study of Denosumab in BRCA1 or BRCA2 Mutation Carriers Scheduling Risk-Reducing Salpingo-Oophorectomy

About the Study

The purpose of this study is to evaluate the effects of denosumab on ovarian cancer risk markers among premenopausal women with a BRCA1 or BRCA2 mutation, who are scheduled to undergo risk-reducing surgery to remove their ovaries and fallopian tubes

UPDATE: THIS STUDY HAS BEEN DISCONTINUED.

Type of Study

This is a randomized, multinational, 2-arm pilot study to evaluate the effects of denosumab on markers in the gynecologic tissues and blood of premenopausal BRCA1 or BRCA2 mutation carriers. You will be randomly assigned (meaning by chance or like tossing a coin) to one of two groups. Neither you nor your doctor will decide which group you are in.

The study has two arms. This means that patients in the study are placed in one of two different groups. 

  • Group 1 (denosumab): 1 or 2 monthly injections of denosumab before risk-reducing surgery; calcium and vitamin D by mouth
  • Group 2 (no denosumab): no treatment for 1-2 months before risk-reducing surgery; calcium and vitamin D by mouth. This group is necessary to understand the effects of denosumab in the group who will receive the injections.

What the Study Entails

  • Premenopausal women with a known BRCA1 or BRCA2 mutation who are planning to have surgery to remove the ovaries and fallopian tubes are eligible to enroll in this study.
  • Women will be randomized to one of the two arms and receive treatment according to the arm they are assigned to. 
  • For women in both groups, Group 1 (denosumab) and Group 2 (no denosumab):
    • Will have a blood draw and pregnancy test upon enrolling in the study.
    • Will take oral calcium and vitamin D supplements for 6 months.
    • Will have surgery as planned to remove the ovaries and fallopian tubes about 1 to 2 months after starting the study. Leftover tissue from the surgery will be used for research purposes.
    • Will need to return for clinic visits about 6 months and 12 months after starting the study for bloodwork and to check for side effects.
  • For women assigned to Group 1 (denosumab):
    • Will receive 1 or 2 monthly injections of denosumab before the scheduled surgery.
    • Will have a blood draw and pregnancy test before each injection.

Study Sites

  • Massachusetts, United States
    • Boston, MA: Dana-Farber Cancer Institute/Brigham and Women’s Hospital
      • Contact: Dr. Judy E. Garber  by phone:  617-632-2282 or by email      
  • New York, United States
    • New York, NY: Columbia University Irving Medical Center
      • Contact: Dr. Meghna S. Trivedi by phone: 212-305-1945  or by email  
    • New York, NY: Weill Cornell Medical Center
      • Contact:  Dr. Kevin Holcomb by phone: 212-746-7553  or by email 
  • Israel
    • Tel Aviv, Israel: Tel Aviv Sourasky Medical Center
      • Contact: Dr. Nadir Arber by phone: 972-3-697-3561 or by email   
    • Tel-Hashomer, Israel: Chaim Sheba Medical Center
      • Contact: Dr. Eitan Friedman MD, PhD by phone: 972-3-530-3173 or by email
This Study is Open To:

UPDATE: THIS STUDY HAS BEEN DISCONTINUED.

This Study is Not Open To: