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NCT03535506 · ClinicalTrials.gov registry record · Phase 2
Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery
A Phase 2 study, sponsored by Georgetown University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT03535506 is a Phase 2 study that was terminated before completion, run by Georgetown University. The registered enrollment target is 17 participants.
The verdict
NCT03535506, a Phase 2 study, was terminated before completion, sponsored by Georgetown University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
This is a feasibility study which will evaluate the effects of pre-operative treatment of DCIS of the breast with palbociclib. Patients with biopsy-proven DCIS are eligible for the study. There will be 2 independent and unrelated study groups of 12 patients each, for a total of 24 patients: 1. Group A, of male or female patients treated with palbociclib single agent (n=12); 2. Group B, untreated, of male or female patients who consented translational studies in blood, as well as diagnostic and definitive surgical specimen, but not the pre-operative treatment with palbociclib (n=12).
Interventions
- DRUG Palbociclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2018-10-08 |
| Est. Completion | 2023-12-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03535506
The ClinicalTrials.gov registry entry for NCT03535506 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Palbociclib is the first listed.
NCT03535506 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03535506 about?
NCT03535506 is a clinical study titled "Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery". This is a feasibility study which will evaluate the effects of pre-operative treatment of DCIS of the breast with palbociclib. Patients with biopsy-proven DCIS are eligible for the study. There will be 2 independent and unrelated study groups of 12 patients each, for a total of 24 patients: 1. Gro...
What is the current status of trial NCT03535506?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2018-10-08. Estimated completion is 2023-12-06.
What interventions are being tested in trial NCT03535506?
The interventions under investigation include: Palbociclib (DRUG).
Who is sponsoring clinical trial NCT03535506?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
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