Romosozumab Tested in Breast Cancer Patients With Bone Spread and Osteoporosis
Tests romosozumab for bone strength in adults with breast cancer spread to bones and osteoporosis.
Plain-language title generated from the registry record
Registry title: A Study of Romosozumab in People With Breast Cancer and Osteoporosis
Key facts
- Where
- Basking Ridge, Commack, Harrison, Middletown, Montvale, New York, and Uniondale, United StatesSee the 7 sites
- Phase
- Phase 2
Where in United States
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking Ridge, United StatesTaking people
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited Protocol Activities)Commack, United StatesTaking people
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)Harrison, United StatesTaking people
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Middletown, United StatesTaking people
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)Montvale, United StatesTaking people
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesTaking people
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)Uniondale, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Memorial Sloan Kettering Cancer Center
- Trial code
- NCT07776613
- Record updated
- 20 August 2026
- Original description
The researchers are doing this study to see if romosozumab is effective at helping with bone formation in people with metastatic breast cancer (MBC) that has spread to the bones. All participants will have osteoporosis. 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.Read full original descriptionShow less
A Phase II Study Evaluating the Efficacy and Safety of Romosozumab as a Bone-Modifying Agent in Patients With Metastatic Breast Cancer to Bones and Osteoporosis With High Fracture Risk (REMOLD-Breast)
The researchers are doing this study to see if romosozumab is effective at helping with bone formation in people with metastatic breast cancer (MBC) that has spread to the bones. All participants will have osteoporosis. 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.
Inclusion: ≥18 years of age at the time of giving informed consent; Patients diagnosed with hormone-receptor positive (ER/PR >1%) metastatic breast cancer to bones on any endocrine therapy with or without targeted therapy (i.e. CDK 4/6 inhibitors, PI3K inhibitors, anti-HER2-therapy); Evidence of osteoporosis on dual X-ray absorptiometry (DXA) scan; must following:; osteoporosis on dual X-ray absorptiometry (DXA) scan; or history of fragility fracture of the spine or hip; or of morphometric spine fracture.
Exclusion: Prior therapy with a bone-modifying agent (intraveous bisphosphonates or subcutaneous denosumab) for metastatic bone disease; History of myocardial infarction or stroke within the preceding year; History of non-healed dental or oral surgery; History of osteonecrosis of the jaw; Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range per institutional standard (<8.5 or >10.5 mg/dL); Calcium repletion will be permitted and subjects will be be rescreened once values are within the institutional standard; 25 (OH) vitamin D levels < 20 ng/mL; Vitamin D repletion will be permitted and subjects will be be rescreened once 25 (OH) vitamin D level ³ 20 ng/mL.