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

Phase 2

Terminated

• Conditions: DCIS
• Interventions: Drug: Palbociclib

• Registration Number: NCT03535506
• Lead Sponsor: Georgetown University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-05-22
• Study First Posted: 2018-05-24
• Study Start: 2018-10-08
• Primary Completion: 2023-12-06
• Study Completion: 2023-12-06
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-16
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Palbociclib	Patients enrolled to Group A will receive a 12-day course of Palbociclib before surgery. They will receive Palbociclib 100mg PO daily x 12 days.

Primary Outcome Measures

Name	Time	Method
Feasibility: recruitment rates	14 - 40 Days	The approach will be considered feasible if more than 50% of the enrolled patients are treated and followed within protocol rules, if collected samples are suitable for studies, and if pathologic changes are detectable when comparing diagnostic and surgical specimens, or treated and untreated specimens. In Group A, patients will be treated with palbociclib alone, providing the opportunity to address if proposing this kind of treatment for these patients is feasible. Obtaining human data and feasibility data would be key for designing efficacy/definitive studies of palbociclib in DCIS. This will be measured through data collected on eCRFs regarding timeline from consent to treatment, and treatment to surgery, including treatment delivery (beginning date, end date, number of tablets taken) and date of definitive surgery, as well as number of drop outs.

Secondary Outcome Measures

Name	Time	Method
Pathology: descriptive findings on H&E	14 - 40 Days	Pharmacodynamic effects as measured by changes in tissue morphology (evaluated by H\&E) in pre- and post-dose tumor specimens
Toxicity based on CTCAE	14 - 40 Days	Will be evaluated by CTCAE. There is no plan to compare Groups A and B regarding efficacy or toxicity. Toxicity will be descriptive for each treatment group, independently.
Pathology: descriptive findings on IHC	14 - 40 Days	Pharmacodynamic effects as measured by changes in biomarkers Cdk4, Cdk6, pRb, Cyclin D1, Cyclin E (evaluated by IHC) in pre- and post-dose tumor specimens.

Trial Locations

Locations (2)

MedStar Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States

Medstar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States