Recruiting
Phase 2

Romosozumab

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07776613

Conditions

Breast Cancer

Metastatic Breast Cancer (MBC)

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Romosozumab

Study Details

Brief summary:

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)

Study ID

NCT07776613

Start date

Aug 17, 2026

Status verified date

Aug, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Romosozumab

Romosozumab will be given on-label at 210 mg

Interventions

Romosozumab

Romosozumab will be given on-label at 210 mg administered SC once monthly for 12 months.

Primary outcome measure

  • Percent change in Procollagen Type 1 N-telopeptide (P1NP ) levels [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Monica Fornier, MD

646-888-5240fornierm@mskcc.org

Jasmeet Singh, MD

914-367-7358

Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Monica Fornier, MD

6468884563

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Monica Fornier, MD

646-888-5240

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Monica Fornier, MD

646-888-5240

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Monica Fornier, MD

646-888-4563

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Monica Fornier, MD

646-888-4563

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Monica Fornier, MD

646-888-5240

Jasmeet Singh, MD

914-367-7358

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Monica Fornier, MD

646-888-4563

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • Romosozumab
  • 26-191

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-08-20.