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Clinical Trial Assessing the Safety of Neoadjuvant Palbociclib in Combination With Endocrine Therapy

NCT05069038 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-12-22

No results posted yet for this study

Summary

Patients with estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) breast cancer do not achieve good responses with pre-operative chemotherapy. The sensitivity of breast cancer to chemotherapy is often determined by the underlying gene expression pattern and the molecular subtype of the tumor. In addition, not all patients tolerate chemotherapy well. Pre-operative endocrine therapy has emerged as an effective strategy to improve outcomes in patients with early-stage hormone receptor positive breast cancer. This study will assess the role of neo-adjuvant palbociclib (CDK 4/6 inhibitor) in combination with letrozole (aromatase inhibitor) +/-Goserelin (GnRH analogue) to improve overall response and surgical feasibility in post and pre-menopausal hormone receptor positive and Her-2 negative subjects with stage IIA-IIIC breast cancer.

Conditions

Interventions

DRUG

Palbociclib 125mg

Palbociclib at a dose of 125 mg should be taken by mouth with food on 21 days on 7 days off schedule (meaning: on Days 1-21of each 28-day cycle). If a subject misses a day's dose entirely, she must be instructed not to make it up the next day but just take her regular dose at the next assigned time. If a subject vomits any time after taking a dose, she must be instructed not to retake the dose but resume subsequent dosing at the next assigned time. If a subject inadvertently takes an extra dose during a day, she must be instructed to not take the next day's dose.

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Amulya Yellala, MBBS · University of Nebraska

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-02
Primary Completion
2026-09-30
Completion
2032-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05069038 on ClinicalTrials.gov