Clinical Trial NU 16B09
- A Phase II, Open label Study to evaluate Denosumab in patients with ER and/or PR-positive, HER2-negative Metastatic Breast Cancer (MBC) with bone metastases and detectable circulating tumor cells (CTCs)
- Principal Investigator
- Massimo Cristofanilli
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.NU 16B09
- The purpose of this study is to look at the amount of cancer cells in the blood of participants who are being treated with denosumab. The other purpose is to look at how long it takes for cancer to get worse when participants are being treated with denosumab.
- Circulating tumor cells (CTCs) in the blood of patients with metastatic breast cancer (MBC) have been associated with shorter survival than when CTCs are absent, especially in patients whose cancer has spread to their bones. In this study, we want it see if denosumab (the study drug) will decrease the number of CTCs measured in patients with MBC and cancer that has spread to their bones. We plan to give 3 doses of denosumab (one every 4 weeks) and find out if it has any effect on CTCs as well as the time it takes for cancer to get worse. We also plan to get blood from participants to study other research markers of interest.
Some of the eligibility criteria include:
- participants must have breast cancer that has spread to the bones.
- participants must have breast cancer that is Her2 negative and ER and/ or PR positive.
- participants must be 18 years of age or older.
- Description of Treatment
- Participants will be asked to come to the outpatient clinic on Day 1 of study treatment. Participants will have a physical exam and blood draw for routine tests then receive the first dose of the study drug (denosumab) which is given subcutaneously (injected under the skin). Participants will continue on the standard of care treatment plan that their doctor recommends (hormones or chemotherapy). Participants will continue to receive injections of denosumab approximately every 28 days (28 days equals 1 cycle). We will check the status of each participant's cancer after every 12 weeks of therapy with imaging tests. Participants will continue to receive study treatments for 3 cycles (12 weeks) or until a) their cancer gets worse, b) they experience serious side effects, or c) they and/or their doctor feel it is best to stop study treatment. After discontinuing treatment for any reason, participants will be followed by the study team approximately every 12 weeks to see how they are doing. Participants will be followed until their cancer gets worse again, they begin another type of treatment for cancer, or they complete 2 years of follow-up.
- Clinical Trials Recruitment Nurse
Robert H. Lurie Comprehensive Cancer Center
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last updated: 19-Oct-17 07:35 AM
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