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A Study of Romosozumab in People With Breast Cancer and Osteoporosis

NCT07776613 · Memorial Sloan Kettering Cancer Center
In plain English

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Official title
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)
About this study
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.
Eligibility criteria
Inclusion Criteria: * ≥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 Criteria: * Prior therapy with a bone-modifying agent (intraveous bisphosphonates or subcutaneous denosumab) for metastatic bone disease; * 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; * History of myocardial infarction or stroke within the preceding year; * 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. * History of non-healed dental or oral surgery; * History of osteonecrosis of the jaw
Study design
Enrollment target: 25 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-08-17
Estimated completion: 2028-08
Last updated: 2026-08-20
Interventions
Drug: Romosozumab
Primary outcomes
  • Percent change in Procollagen Type 1 N-telopeptide (P1NP ) levels (1 year)
Sponsor
Memorial Sloan Kettering Cancer Center · other
With: Hospital for Special Surgery, New York
Contacts & investigators
ContactMonica Fornier, MD · contact · fornierm@mskcc.org · 646-888-5240
ContactJasmeet Singh, MD · contact · 914-367-7358
All locations (7)
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Recruiting
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Recruiting
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)Recruiting
Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)Recruiting
Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)Recruiting
Harrison, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)Recruiting
Uniondale, New York, United States
A Study of Romosozumab in People With Breast Cancer and Osteoporosis · TrialPath