A Study of the Drug Romosozumab in People With Metastatic Breast Cancer and Osteoporosis

https://www.facingourrisk.org/research-clinical-trials/study/433 /a-study-of-the-drug-romosozumab-in-people-with-metastatic-breast-cancer-and-osteoporosis

Clinicaltrials.gov identifier:
NCT07776613 (https://clinicaltrials.gov/show/NCT07776613)

Quality of Life
Phase 2 study for people with metastatic breast cancer and osteoporosis

Study Contact Information:

Name: Monica Fornier, MD
Phone Number: 646-888-5240
Email: [email protected]

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 metastatic 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 osteoporosis in people with MBC that has spread to the bones.

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.

This Study is Open To:

You may be eligible to participate if you :

Have been diagnosed with hormone-receptor positive metastatic breast cancer to which has spread to your bones.
You may be on any endocrine therapy with or without targeted therapy (i.e. CDK 4/6 inhibitors, PI3K inhibitors, anti-HER2-therapy);
You have evidence of osteoporosis 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 metastatic 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.

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.