A Study of Romosozumab in People With Breast Cancer and Osteoporosis
Recruiting
Phase 2Interventional Study
Breast CancerMetastatic Breast Cancer (MBC)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
25 (estimated)
Sponsor
Memorial Sloan Kettering Cancer Center · Other
Who this trial is looking for
This trial is looking for people with metastatic breast cancer that has spread to the bones and osteoporosis. Participants will receive romosozumab to see if it helps with bone health and to check its safety.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older.
I have been diagnosed with metastatic breast cancer that has spread to my bones.
I am currently on hormone therapy for my breast cancer.
I have osteoporosis confirmed by a bone scan or a history of specific bone fractures.
You may not be able to join if
I have received treatment with a bone-modifying agent for my cancer.
My vitamin D levels are below 20 ng/mL.
I have had a heart attack or stroke in the last year.
I have current issues with my calcium levels.
I have a history of dental or oral surgery that has not healed.
I have a history of osteonecrosis of the jaw.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 t…
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.
Trial Locations
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Status
Eligibility Criteria
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);
…
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
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