Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors and Denosumab: An Observational Study to Assess Rebound Bone Loss and Insufficiency Fractures After Denosumab Discontinuation

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Diagnostic test, Other
Study Type: Observational
SUMMARY

The purpose of this study to gather information about changes in the bones after stopping treatment with aromatase inhibitor/AI and denosumab. The study team will collect information from 5 standard clinic visits over the course of 24 months. The information will include information about participant health assessments, blood test results, and imaging results. After 24 months, participation in this study will be complete.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Women with confirmed diagnosis of breast cancer

• Participant must be post-menopausal, defined as last menstrual cycle at least 12 months prior to enrollment

• Received at least 2 doses of denosumab and then discontinued therapy

• Discontinued AI prior to or within 6 months of last denosumab injection

• Patients must be 18 years of age or olde

Locations
United States
New Jersey
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
RECRUITING
Uniondale
Contact Information
Primary
Monica Fornier, MD
fornierm@mskcc.org
646-888-4563
Backup
Azeez Farooki, MD
farookia@mskcc.org
646-608-3798
Time Frame
Start Date: 2022-10-18
Estimated Completion Date: 2026-10-18
Participants
Target number of participants: 100
Treatments
Post- menopausal breast cancer patients
Participants are post- menopausal with a breast cancer diagnosis who received at least 2 doses of denosumab, and then discontinued therapy, and discontinued Aromatase Inhibitors/AI prior to or within 6 months of stopping denosumab
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov