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

NCT03535506 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 2018-0075
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

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. 1.Group A, of male or female patients treated with palbociclib single agent (n=12);
2. 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

Keywords

Breast Cancer; DCIS; Ductal Carcinoma In Situ; Palbociclib

Outcome Measures

Primary Outcomes (1)

• Feasibility: Recruitment Rates

  The approach will be considered feasible if more than 50% of the enrolled patients are treated andcomplete the study.

  5 years

Secondary Outcomes (3)

• Pathologic Changes

  2 months

• Pathology Changes on Immunohistochemistry (IHC)

  2 months

• Toxcity Based on CTCAE

  3 months

Study Arms (2)

Group A

EXPERIMENTAL

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.

Drug: Palbociclib

Group B

NO INTERVENTION

These patients will receive no pre-operative treatment. Core biopsies from diagnosis and material from definitive surgery will be collected for translational studies and tissue banking. They will also provide blood samples at screening and prior to definitive surgery.

Interventions

Palbociclib DRUG

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

Also known as: Ibrance

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patients must be able and willing to swallow and retain oral medication
• Absolute neutrophil count (ANC) ≥ 1,500/mm3
• Platelets ≥ 120,000/mm3
• Hemoglobin ≥ 10g/dL
• Total serum bilirubin ≤ ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range in patients with documented Gilbert's Syndrome.

You may not qualify if:

• 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).
• Patients receiving any medications or substances that are potent inhibitors or inducers of CYP3A isoenzymes within 7 days of enrollment or during participation on study
• Patients with clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis, etc.

Sponsors & Collaborators

• Georgetown University: lead
• Pfizer: collaborator

Study Sites (2)

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Breast Neoplasms

Interventions

palbociclib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Nicole Swanson
• Organization: Georgetown University

ns1209@georgetown.edu

2026879194

Study Officials

• Candace Mainor, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: May 24, 2018
• Study Start: October 8, 2018
• Primary Completion: December 6, 2023
• Study Completion: December 6, 2023
• Last Updated: September 26, 2025
• Results First Posted: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)