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Romosozumab to Promote Bone Formation in Patients with Metastatic Breast Cancer to Bones and Osteoporosis, REMOLD-Breast Trial
Trial Status: active
This phase II trial tests the effectiveness of romosozumab for improving bone formation in patients with breast cancer that has spread from where it first started (primary site) to the bone (metastatic) and osteoporosis. Osteoporosis is a condition that involves loss of bone density and mass, which causes the bones to become fragile. Breast cancer frequently spreads to the bones and many people with metastatic breast cancer develop osteoporosis which increases their risk for bone fractures. Romosozumab is a monoclonal antibody that blocks a protein in the body called sclerostin, which decreases bone formation. This may help increase bone formation as well as decrease bone breakdown (resorption) in people with osteoporosis. Giving romosozumab may be safe, tolerable, and/or effective in improving bone formation in patients with metastatic breast cancer to the bones with osteoporosis.
Inclusion Criteria
≥ 18 years of age at the time of giving informed consent
Patients diagnosed with hormone-receptor positive (estrogen receptor [ER]/progesterone receptor [PR] > 1%) metastatic breast cancer to bones on any endocrine therapy with or without targeted therapy (i.e. cyclin-dependent kinase [CDK] 4/6 inhibitors, PI3K inhibitors, anti-HER2-therapy)
Evidence of osteoporosis on dual X-ray absorptiometry (DXA) scan; must have one of the following:
* Osteoporosis on dual X-ray absorptiometry (DXA) scan; or
* History of fragility fracture of the spine or hip; or of morphometric spine fracture
Have given informed consent (IC) by signing and dating the IC form (ICF) before initiation of any trial-specific procedures
Are willing and able to comply with scheduled visits, the treatment schedule, the planned trial assessments and other requirements of the trial
Prior oral and intravenous bisphosphonates at the osteoporosis dosing schedule are allowed if the last dose was more or equal to 3 months prior to study enrollment
Prior denosumab therapy at the osteoporosis dosing schedule is allowed if the last dose was more or equal to 18 months prior to study enrollment
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 rescreened once 25 (OH) vitamin D level 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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07776613.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Monica N. Fornier
Phone: 646-888-5240
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Monica N. Fornier
Phone: 646-888-5240
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Monica N. Fornier
Phone: 646-888-5240
New York
Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Monica N. Fornier
Phone: 646-888-5240
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Monica N. Fornier
Phone: 646-888-5240
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Monica N. Fornier
Phone: 646-888-5240
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Monica N. Fornier
Phone: 646-888-5240
PRIMARY OBJECTIVE:
I. To evaluate the percent change of the bone formation marker serum procollagen type 1 N-telopeptide (P1NP), from baseline during romosozumab treatment (specifically at 1 month after starting romosozumab) in patients with metastatic breast cancer (MBC) to bone, and osteoporosis.
SECONDARY OBJECTIVES:
I. To evaluate the safety of romosozumab in patients with MBC to bones by evaluating adverse events using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 6.0.
II. To assess percent change in other serum bone turnover markers (type 1 collagen C-telopeptide [b-CTX], bone-specific alkaline phosphatase [BSAP], and osteocalcin [OC]), and P1NP at baseline, 1, 3, 6, and 12 months of romosozumab therapy.
III. To assess incidence of and time to first on-study skeletal related event (SRE) and/or fragility fracture.
IV. To assess the effect of romosozumab on bone metastases by positron emission tomography (PET)/computed tomography (CT) scan between baseline and end of treatment (12 months).
V. To assess the effect of romosozumab on dual X-ray absorptiometry (DXA) bone mineral density with trabecular bone score (TBS) at 12 months.
EXPLORATORY OBJECTIVES:
I. To assess lean mass changes through DXA bone mineral density and anthropometric measurements (weight, height, body mass index [BMI]).
II. To explore histomorphometry analysis of osteoclasts and osteoblasts on metastatic bone biopsy samples pre and post exposure to romosozumab, and other elements of bone microenviroment.
OUTLINE:
Patients receive romosozumab subcutaneously (SC) once montly (QM) for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, fludeoxyglucose F-18 (FDG) PET/CT, and DXA throughout the study. Additionally, patients may undergo bone biopsy if safe and feasible throughout the study.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
