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

What this trial studies

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.

Conditions in scope

• Breast Cancer

Interventions

• Palbociclib 125mg (Drug) — 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…

Who can join

Women only · Ages 19 Years and up

Inclusion criteria

• Histologically confirmed locally advanced stage ER+ and/or PR+ and HER2- breast cancer \[by ASCO/CAP guidelines: primary tumor size 2 cm or greater OR if primary tumor size is \<2 cm with lymph node involvement (Stage II)\] who are candidates for palbociclib in combination with concurrent ovarian suppression and letrozole per treating physician.
• At least 19 years of age.
• ECOG performance status ≤ 2 (see Appendix A)
• Normal bone marrow and organ function as defined below:
• Absolute neutrophil count ≥ 1,500/mcl
• Platelets ≥ 100,000/mcl
• Total bilirubin ≤ IULN or total bilirubin ≤ 3.0 x IULN with direct bilirubin within normal range in subjects with documented Gilbert's syndrome
• AST(SGOT)/ALT(SGPT) ≤ 1.5 x IULN (up to 5 x IULN in subjects with liver disease)

Exclusion criteria

• Prior therapy with any CDK inhibitor.
• Currently receiving any other investigational agents.
• Currently receiving exogenous hormone therapy (topical vaginal estrogen therapy is allowed).
• Known metastatic disease
• A history of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib or other agents used in the study.
• Receiving any medications or substances that are potent inhibitors or inducers of CYP3A isoenzymes within 7 days prior to registration.
• Clinically significant history of liver disease as defined by active hepatitis and/or cirrhosis with compromised liver function.
• A condition that would interfere with enteric absorption.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Active, not recruiting
• Study type: Interventional
• Phase: PHASE2
• Start date: 2022-03-02
• Primary completion: 2026-09
• Last update posted: 2025-12-22
• First posted: 2021-10-06

Sponsor & contact

Lead sponsor: University of Nebraska (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Overall response rate (CR+PR) with neoadjuvant palbociclib in combination with endocrine therapy (6 Months)
  To determine the overall response rate (CR+PR) with neoadjuvant palbociclib in combination with endocrine therapy in subjects with hormone receptor positive and Her-2/neu negative breast cancer
• Rate of reduction of Ki67 index (4 Weeks)
  To determine the rate of reduction of Ki67 index after 4 weeks of neoadjuvant Palbociclib and endocrine therapy

Related ClearedRx care

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