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NCT02613416 · ClinicalTrials.gov registry record · Phase 2
Denosumab and MRI Breast Imaging
A Phase 2 study, sponsored by Alison Stopeck.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT02613416 is a Phase 2 study that has completed, run by Alison Stopeck. The registered enrollment target is 42 participants.
The verdict
NCT02613416, a Phase 2 study, has completed, sponsored by Alison Stopeck.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study Summary
This is a non-randomized phase II trial of denosumab at 120 mg subcutaneous injection monthly in pre- and post-menopausal women diagnosed with stage 0-III breast cancer who are currently not receiving anticancer treatment with hormonal therapies, chemotherapy, or radiation. All patients will undergo quantification of breast density by MRI at baseline and after 6 months on denosumab. Because the therapeutic agent is an injectable drug, the investigators will conduct a single arm study with both pre- and post-treatment measurements to determine the extent of variability in breast density over time and a placebo treatment period or group will not be utilized. This is an investigator initiated trial and Amgen (SPONSOR) will provide the trial drug denosumab.
Interventions
- DRUG Denosumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2015-11 |
| Est. Completion | 2021-08-20 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02613416
The ClinicalTrials.gov registry entry for NCT02613416 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alison Stopeck, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Denosumab is the first listed.
NCT02613416 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02613416 about?
NCT02613416 is a clinical study titled "Denosumab and MRI Breast Imaging". This is a non-randomized phase II trial of denosumab at 120 mg subcutaneous injection monthly in pre- and post-menopausal women diagnosed with stage 0-III breast cancer who are currently not receiving anticancer treatment with hormonal therapies, chemotherapy, or radiation. All patients will undergo...
What is the current status of trial NCT02613416?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2015-11. Estimated completion is 2021-08-20.
What interventions are being tested in trial NCT02613416?
The interventions under investigation include: Denosumab (DRUG).
Who is sponsoring clinical trial NCT02613416?
This trial is sponsored by Alison Stopeck, which has 3 total clinical trials registered on ClinicalTrials.gov.
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