A Study of Romosozumab in People With Breast Cancer and Osteoporosis

Purpose

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.

Conditions

  • Breast Cancer
  • Metastatic Breast Cancer (MBC)

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
This is a phase II single arm study.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Romosozumab 		Romosozumab will be given on-label at 210 mg
  • Drug: Romosozumab
    Romosozumab will be given on-label at 210 mg administered SC once monthly for 12 months.

Recruiting Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920
Contact:
Monica Fornier, MD
6468884563

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey 07748
Contact:
Monica Fornier, MD
646-888-5240

Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey 07645
Contact:
Monica Fornier, MD
646-888-5240

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
Commack, New York 11725
Contact:
Monica Fornier, MD
646-888-4563

Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York 10604
Contact:
Monica Fornier, MD
646-888-4563

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
Monica Fornier, MD
646-888-5240

Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York 11553
Contact:
Monica Fornier, MD
646-888-4563

More Details

Status
Recruiting
Sponsor
Memorial Sloan Kettering Cancer Center

Study Contact

Monica Fornier, MD
646-888-5240
fornierm@mskcc.org