Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Northwestern University
With
PRIMARY OBJECTIVES: I. To assess the effect of denosumab in Her2/neu negative ER+ and/or PR+ metastatic breast cancer patients who are in partial response (PR) or stable disease (SD) after starting systemic therapy with bone metastases and \>= 5 circulating tumor cells (CTCs) by measuring the fraction of patients with reduction in CTCs after 3 cycles of denosumab. SECONDARY OBJECTIVES: I. To assess the effect of denosumab on CTCs enumeration considered as a continuous variable (percent change from baseline) in this population. II. To evaluate median progression-free survival (m-PFS). TERTIARY OBJECTIVES: I. CTC enumeration after enrichment. II. To assess the effect on CTC profiling and characterization of stem cell phenotype (CTC-EMT). III. To evaluate the type of progressive disease (new site versus \[vs.\] progression of lesions in previous sites). IV. To analyze the expression of RANKL. OUTLINE: Patients receive denosumab subcutaneously (SC) on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression, unexpected toxicity, or patient withdrawal or death. After completion of study treatment, patients are followed up every 12 weeks for up to 2 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
