Pilot Study of Denosumab in BRCA1 or BRCA2 Mutation Carriers Scheduling Risk-Reducing Salpingo-Oophorectomy
https://www.facingourrisk.org/research-clinical-trials/study/74/denosumab-in-brca1-or-brca2-mutation-carriers-scheduling-risk-reducing-salpingo-oophorectomy
Clinicaltrials.gov identifier:
NCT03382574 (https://clinicaltrials.gov/show/NCT03382574)
Study Contact Information:
Contact: Dr. Meghna S. Trivedi by phone: 212-305-1945 or by email
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
- Boston, MA: Dana-Farber Cancer Institute/Brigham and Women’s Hospital
- New York, United States
- Israel
This Study is Open To:
UPDATE: THIS STUDY HAS BEEN DISCONTINUED.
This Study is Not Open To:
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.