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PAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY

NCT03423199 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2024-03-22

No results posted yet for this study

Summary

This study is conducted to evaluate the benefit of adding palbociclib in hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer patients, regardless of menopausal status, treated with tamoxifen (with or without goserelin) versus tamoxifen alone (with or without goserelin).

Conditions

  • Breast Neoplasms

Interventions

DRUG

Palbociclib

Palbociclib, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment

DRUG

Placebo

Placebo, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment

DRUG

Tamoxifen

Tamoxifen, 20mg, orally once daily (continuously)

DRUG

Goserelin

For pre/perimenopausal patients only: Goserelin, 3.6 mg, subcutaneously every 4 weeks; or 10.8 mg, subcutaneously every 12 weeks

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Korean Cancer Study Group

    collaborator OTHER

  • National Cancer Center, Japan

    lead OTHER_GOV

Principal Investigators

  • Kan Yonemori, MD, PhD · Department of Breast and Medical Oncology, National Cancer Center Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-09
Primary Completion
2025-09-30
Completion
2025-09-30
FDA Drug
Yes

Countries

  • Japan
  • Singapore
  • South Korea
  • Taiwan

Study Locations

More Related Trials

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 NCT03423199 on ClinicalTrials.gov