drugset / Trial / NCT03535506
Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Palbociclib | Small molecule | 100 mg | Oral |