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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

February 9, 2018

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2025

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

Trial Locations (23)

10048

National Taiwan University Hospital, Taipei

10408

National Cancer Center, Gyeonggi-do

11217

Taipei Vetarans General Hospital, Taipei

11259

Sun Yat-Sen Cancer Center, Taipei

16499

Ajou University Hospital, Gyeonggi-do

119882

National University Hospital, Singapore

169610

National Cancer Centre Singapore, Singapore

1058470

Toranomon Hospital, Minato-Ku

2418515

Kanagawa Cancer Center, Yokohama

2608717

Chiba Cancer Center, Chiba

2778577

National Cancer Center Hospital East, Kashiwa

5400006

National Hospital Organization Osaka National Hospital, Osaka

5898511

Kindai University Hospital, Ōsaka-sayama

6738558

Hyogo Cancer Center, Akashi

7910280

National Hospital Organization Shikoku Cancer Center, Matsuyama

8111395

Kyusyu Cancer Center, Fukuoka

464-8681

Aichi Cancer Center Hospital, Nagoya

0030804

National Hospital Organization Hokkaido Cancer Center, Sapporo

104-0045

National Cancer Center Hospital, Tokyo

463-707

Seoul National University Bundang Hospital, Gyeonggi-do

03080

Seoul National University Hospital, Seoul

05505

Asan Medical Center, Seoul

03722

Severance Hospital, Yonsei University Health System, Soeul

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

collaborator

Korean Cancer Study Group

OTHER

lead

National Cancer Center, Japan

OTHER_GOV

NCT03423199 - PAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY | Biotech Hunter | Biotech Hunter