A Study of the Drug Romosozumab in People With Metastatic Breast Cancer and Osteoporosis
Quality of Life
Phase 2 study for people with metastatic breast cancer and osteoporosis
Clinicaltrials.gov identifier:NCT07776613
Study Contact Information:
Name: Monica Fornier, MD
Phone Number: 646-888-5240
Email: [email protected]
or
Name: Jasmeet Singh, MD
Phone Number: 914-367-7358
About the Study
The researchers are doing this study to see if the drug romosozumab is effective at helping with bone formation in people with breast cancer (MBC) that has spread to the bones. The researchers will also look at bone breakdown (resorption) in participants and determine if romosozumab is a safe treatment for in people with MBC that has spread to the bones.
This Study is Open To:
You may be eligible to participate if you :
- Have been diagnosed with hormone-receptor positive breast cancer to which has spread to your bones.
- You may be on any endocrine therapy with or without (i.e. CDK 4/6 inhibitors, PI3K inhibitors, anti-HER2-therapy);
- You have evidence of on dual X-ray absorptiometry (DXA) scan or history of fragility fracture of the spine or hip.
This Study is NOT Open To:
You would not be eligible if:
- You have previously received treatment with a bone-modifying drug such as Reclast, Zometa, Prolia or Xgeva for bone disease.
- Your vitamin D or calcium levels are too low. Potential participants who are taking vitamin D and/or calcium supplements may be able to participate once their values are within normal range.
- You have a history of heart attack or stroke within the last year.
- You have a history of non-healed dental or oral surgery.
- You have a history of osteonecrosis of the jaw.
What the Study Involves
Everyone in the study will receive the study drug, romosozumab.
- Romosozumab will be given as an injection under the skin once monthly for 12 months.
- Participants will have blood tests to look at markers that indicate changes in the bone.
Study Contact Information:
Name: Monica Fornier, MD
Phone Number: 646-888-5240
Email: [email protected]
or
Name: Jasmeet Singh, MD
Phone Number: 914-367-7358
Locations:
New Jersey
City: Basking Ridge RECRUITING
Facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Contact Info:
6468884563
City: Middletown RECRUITING
Facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Contact Info:
646-888-5240
City: Montvale RECRUITING
Facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Contact Info:
646-888-5240
New York
City: Commack RECRUITING
Facility: Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
Contact Info:
646-888-4563
City: Harrison RECRUITING
Facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Contact Info:
646-888-4563
City: New York RECRUITING
Facility: Memorial Sloan Kettering Cancer Center
Contact Info:
646-888-5240
914-367-7358
City: Uniondale RECRUITING
Facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Contact Info:
646-888-4563
Quality of Life
Phase 2 study for people with metastatic breast cancer and osteoporosis
Clinicaltrials.gov identifier:NCT07776613
Study Contact Information:
Name: Monica Fornier, MD
Phone Number: 646-888-5240
Email: [email protected]
or
Name: Jasmeet Singh, MD
Phone Number: 914-367-7358