Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-02-27 @ 8:48 AM
Study NCT ID:
NCT03070002
Status:
TERMINATED
Last Update Posted:
2018-11-20
First Post:
2017-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Denosumab in Treating Patients With ER and/or PR Positive, HER2 Negative Metastatic Breast Cancer With Bone Metastases and Detectable Circulating Tumor Cells
Sponsor:
Northwestern University
Organization:
Study Overview
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)
Status:
TERMINATED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 also plan to get blood from participants to study other research markers of interest.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| STU00203216 | None | CTRP (Clinical Trial Reporting Program) | View | |
| NU 16B09 | OTHER | Northwestern University | View | |
| P30CA060553 | NIH | None | https://reporter.nih.gov/quic… | View |
| NCI-2017-00015 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |