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

NCT03535506 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-09-26

Study results available
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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

DRUG

Palbociclib

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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Georgetown University

    lead OTHER

Principal Investigators

  • Candace Mainor, MD · Georgetown University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-08
Primary Completion
2023-12-06
Completion
2023-12-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03535506 on ClinicalTrials.gov