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NCT03070002 · ClinicalTrials.gov registry record · Phase 2
Denosumab in Treating Patients With ER and/or PR Positive, HER2 Negative Metastatic Breast Cancer With Bone Metastases and Detectable Circulating Tumor Cells
A Phase 2 study, sponsored by Northwestern University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT03070002: Clinical Trial Phase 2 study, sponsored by Northwestern University.
NCT03070002 is a Phase 2 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03070002, a Phase 2 study, was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Denosumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2017-10-19 |
| Est. Completion | 2018-04-24 |
| Phase | Phase 2 |
Why NCT03070002 stopped before completion
NCT03070002 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT03070002 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03070002 about?
NCT03070002 is a clinical study titled "Denosumab in Treating Patients With ER and/or PR Positive, HER2 Negative Metastatic Breast Cancer With Bone Metastases and Detectable Circulating Tumor Cells". 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 bl...
What is the current status of trial NCT03070002?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2017-10-19. Estimated completion is 2018-04-24.
What interventions are being tested in trial NCT03070002?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Denosumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03070002?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03070002's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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