Romosozumab for bone formation in people with breast cancer and osteoporosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study evaluates the effect of romosozumab on bone formation and bone resorption in patients with ER/PR-positive metastatic breast cancer involving bone and with osteoporosis. Participants receive romosozumab and are assessed for changes in bone turnover and safety in the context of metastatic disease and standard cancer therapies. Eligible individuals are adults with bone-dominant metastatic breast cancer on endocrine therapy, who have osteoporosis by DXA or a history of fragility fracture. Exclusion criteria include prior bone-modifying agent use for metastatic bone disease, low vitamin D that cannot be corrected promptly, recent cardiovascular events, and abnormal calcium levels. The trial is led by Memorial Sloan Kettering Cancer Center with collaboration from Hospital for Special Surgery, conducted at MSK locations in New Jersey with limited protocol activities.

Why it matters

Who can join: the full rules

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

Where it's running

• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (Limited Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (Limited Protocol Activities)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Monica Fornier, MD
• Email: fornierm@mskcc.org
• Phone: 646-888-5240

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.