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Brief Title: PAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY
Official Title: 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
Study ID: NCT03423199
Brief 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).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Aichi Cancer Center Hospital, Nagoya, Aichi, Japan
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan
National Hospital Organization Hokkaido Cancer Center, Sapporo, Hokkaido, Japan
Hyogo Cancer Center, Akashi, Hyogo, Japan
Kanagawa Cancer Center, Yokohama, Kanagawa, Japan
Kindai University Hospital, Ōsaka-sayama, Osaka, Japan
Toranomon Hospital, Minato-Ku, Tokyo, Japan
Chiba Cancer Center, Chiba, , Japan
Kyusyu Cancer Center, Fukuoka, , Japan
National Hospital Organization Osaka National Hospital, Osaka, , Japan
National Cancer Center Hospital, Tokyo, , Japan
National Cancer Center, Gyeonggi-do, , Korea, Republic of
Ajou University Hospital, Gyeonggi-do, , Korea, Republic of
Seoul National University Bundang Hospital, Gyeonggi-do, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Soeul, , Korea, Republic of
National University Hospital, Singapore, , Singapore
National Cancer Centre Singapore, Singapore, , Singapore
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Vetarans General Hospital, Taipei, , Taiwan
Sun Yat-Sen Cancer Center, Taipei, , Taiwan
Name: Kan Yonemori, MD, PhD
Affiliation: Department of Breast and Medical Oncology, National Cancer Center Hospital
Role: STUDY_CHAIR