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Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

NCT03535506•Georgetown University

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed informed consent obtained prior to any study specific assessments and procedures
•Age ≥18 years
•Premenopausal and postmenopausal women, or men
•Current pathologic diagnosis of DCIS of the breast of any receptor status; History of previous DCIS allowed provided that the patient is currently off systemic risk-reduction endocrine therapy; History of previous invasive breast cancer adequately treated and that is currently in remission and unrelated to current DCIS (based on primary tumor location) is allowed as long as patient is currently off systemic therapy for that invasive cancer for at least 4 weeks prior to pre-treatment biopsy (diagnostic biopsy); Patients with multifocal or multicentric lesions are allowed, as long as at least one lesion is histologically confirmed DCIS and overall clinical AJCC Stage 0 or I.
•A formalin-fixed paraffin-embedded (FFPE) tumor tissue block from diagnostic biopsy must be transmitted to MedStar Georgetown University Hospital Pathology Department repository and confirmation of receipt must be available prior to enrollment.
•Positive Rb by immunohistochemistry in the DCIS component of the lesion - must be performed at CLIA-approved setting (for instance, MGUH); Rb staining will be considered positive when 1+ or above (in a scale of 0, 1+, 2+ or 3+)
•In the absence of histologic diagnosis of DCIS, patient may undergo fresh biopsy for eligibility, provided: this invasive procedure is not a Fine Needle Aspiration (FNA); AND this procedure is a core biopsy, stereotactic biopsy or incisional biopsy of the suspicious breast lesion; AND the primary lesion is not completely resected during the procedure.
•The patient is candidate for and is willing to receive definitive surgical therapy for DCIS
•ECOG performance status 0-1
•Willingness to provide a sample of tissue collected at definitive surgery for research
+9 more criteria

Exclusion Criteria

•Concurrent therapy with other Investigational Products
•Invasive carcinoma present in the diagnostic biopsy, microinvasion is allowed
•Uncontrolled intercurrent illness including (active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes, pulmonary embolism in the past 6 months, or psychiatric illness/social situations that would limit compliance with study requirements).
•Unable to comply with study requirements
•Hormone therapies containing estrogen, progesterone, GnRH agonists and antagonists within 4 weeks from diagnostic biopsy.
•Therapy with any CDK inhibitor in the past 3 months
•History of allergic reactions attributed to compounds of chemical or biologic composition similar to palbociclib
•Presence of a condition that would interfere with enteric absorption of palbociclib
•Pregnant women, or women of childbearing potential without a negative pregnancy test (serum or urine) within 7 days prior to enrollment; breastfeeding must be discontinued prior to study entry (Group A only).
•Patients on combination antiretroviral therapy, i.e. those who are HIV+ (potential for pharmacokinetic interactions or increased immunosuppression with palbociclib).
+2 more criteria

Locations (2)

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

Key Dates

Start Date

October 8, 2018

Primary Completion Date

December 6, 2023

Completion Date

December 6, 2023

Last Updated

September 26, 2025

Enrollment

ACTUAL participants

Conditions

DCIS

Interventions

Palbociclib

DRUG

Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS)

NCT04797299

DCIS

View study

RECRUITINGPHASE2

Study of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer

NCT04084730

Invasive Ductal Breast CarcinomaInvasive Ductal Carcinoma, Breast+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS)

Study of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer

Ultra Hypo-fractionated Adjuvant Whole Breast Radiation Therapy With Simultaneous Integrated Boost for Early-Stage Breast Cancer (H-ASSIST)

The PREDICT Registry:

The AUS-PREDICT Registry for DCIS Patients With DCISionRT Testing

LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer