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Neoadjuvant Hormonal Therapy Plus Palbociclib in Operable, Hormone Sensitive and HER2-Negative Primary Breast Cancer

NCT03969121 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2023-03-10

No results posted yet for this study

Summary

The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the efficacy of palbociclib in combination with Endocrine therapy over Endocrine therapy alone measured by PEPI and EndoPredict™ EPclin Score in women with operable HR+, HER2 negative breast cancer . The Clinical Response Rate, drop in Ki67 index ≤ 2.7% and Breast conserving rate will be compared between two arms.

Conditions

  • Breast Cancer Female
  • Hormone Receptor Positive Malignant Neoplasm of Breast

Interventions

DRUG

Palbociclib

Palbociclib will be administered orally once a day for 21 days every 28-day cycle followed by 7 days off treatment

DRUG

Endocrine therapy

Pre- and peri-menopausal women will be receiving Ovarian Function Suppression (OFS) by either leuprorelin subcutaneous 3.75 mg q28days or goserelin subcutaneous 3.6 mg q28days plus tamoxifen 20 mg QD in 28-day cycles. Post-menopausal women will receive letrozole 2.5 mg QD in 28-day cycles.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Kyoto Breast Cancer Research Network

    lead OTHER

Principal Investigators

  • Masakazu Toi, MD,PhD · Kyoto University, Professor of Breast Surgery Department

  • Louis WC Chow, MD,PhD · Organisation for Oncology and Translational Research (OOTR)

  • Takayuki Ueno, MD,PhD · Cancer Institute Hospital of JFCR, Department Director, Breast Surgical Oncology Department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-16
Primary Completion
2021-12-23
Completion
2021-12-23
FDA Drug
Yes

Countries

  • Australia
  • Hong Kong
  • Japan
  • South Korea
  • Taiwan

Study Locations

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Entities

Drugs
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 NCT03969121 on ClinicalTrials.gov