NCT03423199

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

Asian, International, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Tamoxifen With or Without Palbociclib ± Goserelin in Women With Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: National Cancer Center, Japan · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2018-02-09
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2018-02-06
• Last updated: 2024-03-22

Locations

23 sites across 4 countries: Japan, Singapore, South Korea, Taiwan

Regulatory

• FDA-regulated drug study