A Study of Romosozumab in People With Breast Cancer and Osteoporosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
≥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);
osteoporosis on dual X-ray absorptiometry (DXA) scan; or history of fragility fracture of the spine or hip; or of morphometric spine fracture;
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Romosozumab
DrugRomosozumab will be given on-label at 210 mg administered SC once monthly for 12 months.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: RomosozumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percent change in Procollagen Type 1 N-telopeptide (P1NP ) levels
Blood samples for the panel of bone turnover markers
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
Hospital for Special Surgery, New York
Collaborator
Source ClinicalTrials.gov