drugset / Trial / NCT03535506

Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery

NCT03535506 ↗

Phase 2 Terminated 17 enrolled Georgetown University Pfizer · collab
Non-randomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2018-10-08
Primary completion
2023-12-06
Completion
2023-12-06

Outcome

Outcome not reported

Stopped (Enrollment): “lack of accrual”

Drugs

EvaluationDrugModalityDoseRoute
Subject Palbociclib Small molecule 100 mg Oral