Denosumab in Treating Patients With ER and/or PR Positive, HER2 Negative Metastatic Breast Cancer With Bone Metastases and Detectable Circulating Tumor Cells
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|ClinicalTrials.gov Identifier: NCT03070002|
Recruitment Status : Terminated (Low accrual)
First Posted : March 3, 2017
Results First Posted : November 20, 2018
Last Update Posted : November 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Carcinoma Metastatic in the Bone Circulating Tumor Cell Count Estrogen Receptor Positive HER2/Neu Negative Progesterone Receptor Positive Stage IV Breast Cancer||Biological: Denosumab Other: Laboratory Biomarker Analysis||Phase 2|
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.
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).
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||October 19, 2017|
|Actual Primary Completion Date :||March 6, 2018|
|Actual Study Completion Date :||April 24, 2018|
Experimental: Treatment (denosumab)
Patients receive denosumab 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.
Other: Laboratory Biomarker Analysis
- Fraction of Patients With Reduction in CTCs [ Time Frame: Up to 3 months ]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 CTCs by measuring the fraction of patients with reduction in CTCs.
- Percent Change in CTCs [ Time Frame: Baseline up to 3 months ]Evaluate the effect of denosumab on CTCs enumeration by assessing the percent change from baseline.
- Median Progression Free Survival [ Time Frame: Up to 2 years ]Assess median progression free survival (m-PFS) using statistical analysis evaluating the relationship between longitudinal CTC counts and PFS. PRS will be measured from the time of treatment up until progressive disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070002
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Northwestern University- Lake Forest Hospital|
|Lake Forest, Illinois, United States, 60045|
|Principal Investigator:||Sarika Jain, MD||Northwestern University|