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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: Clinical Trial Phase 2 study, sponsored by Georgetown University.
NCT03535506 is a Phase 2 study that was terminated before completion, run by Georgetown University. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The approach will be considered feasible if more than 50% of the enrolled patients are treated andcomplete the study.
Interventions
- DRUG Palbociclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2018-10-08 |
| Est. Completion | 2023-12-06 |
| Phase | Phase 2 |
Why NCT03535506 stopped before completion
NCT03535506 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Palbociclib is the first listed.
NCT03535506 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03535506's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 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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