NCT03535506

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• DCIS

Interventions

Type	Name	Description
DRUG	Palbociclib	Palbociclib capsules for oral administration contain 125 mg, 100 mg, or 75 mg of palbociclib, a kinase inhibitor.

Timeline

• Start date: 2018-10-08
• Primary completion: 2023-12-06
• Completion: 2023-12-06
• First posted: 2018-05-24
• Last updated: 2025-09-26
• Results posted: 2025-09-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study