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Brief Title: A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare NSAI (Anastrozole or Letrozole) Plus Abemaciclib, a CDK4 and CDK6 Inhibitor, or Plus Placebo, and to Compare Fulvestrant Plus Abemaciclib or Plus Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer
Study ID: NCT02763566
Brief Summary: The main purpose of this study is to evaluate the efficacy of the study drug abemaciclib in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locoregionally recurrent or metastatic breast cancer.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
ONCOSITE - Centro de Pesquisa Clinica em Oncologia, Ijui, Rio Grande Do Sul, Brazil
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa, Porto Alegre, Rio Grande Do Sul, Brazil
Fundação Pio XII - F44tal de Câncer de Barretos, Barretos, Sao Paulo, Brazil
Hospital de Base de Sao Jose do Rio Preto, São José do Rio Preto, Sao Paulo, Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo, Sao Paulo, , Brazil
Clínica de Pesquisa e Centro de Estudos em Ginecologia Oncológica e Mamária LTDA, São Paulo, , Brazil
Afflilated Hospital of Bengbu Medical College, Bengbu, Anhui, China
The Fifth Medical Center of PLA General Hospital, Beijing, Beijing, China
Beijing Cancer Hospital, Beijing, Beijing, China
Fujian Provincial Cancer hospital, Fuzhou, Fujian, China
Fuzhou General hospital of Nanjing Military Command, Fuzhou, Fujian, China
Guangxi Medical University Affiliated Tumor Hospital, Nanning, Guang XI, China
Guangdong Province People's Hospital, Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China
The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
Harbin Medical University Caner Hospital, Harbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Wuhan Union Hospital Cancer Center, Wuhan, Hubei, China
Tongji Hospital Tongji Medical, Science & Technology, Wuhan, Hubei, China
Hubei Cancer Hospital, Wuhan, Hubei, China
Hunan Cancer Hospital, Changsha, Hunan, China
Jilin Cancer Hospital, Chang Chun, Ji Lin, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China
Jiangsu Cancer Hospital, Nanjing, Jiangsu, China
Jiangsu Province Hospital, Nanjing, Jiangsu, China
The 2nd Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China
Liaoning Cander Hospital&Institute, Shenyang, Liaoning, China
The first affiliated hospital of China medical university, Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
Shanghai General Hospital, Shanghai, Shanghai, China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
The Second Affiliate Hospital of Zhejiang University School of medicine, Hangzhou, Zhejiang, China
Dr. B. L. Kapur Memorial Hospital, New Delhi, Delhi, India
The Gujarat Cancer & Research Institute (GCRI), Ahmedabad, Gujarat, India
Healthcare Global Enterprises Limited (HCG), Bangalore, Karnataka, India
M S Ramaiah Medical College Hospitals, Bangalore, Karnataka, India
Tata Memorial Hospital, Mumbai, Maharashtra, India
Jehangir Hospital, Pune, Maharashtra, India
Christian Medical College Vellore, Ranipet, Tamil Nadu, India
Medica Superspecialty Hospital, Kolkata, West Bengal, India
The Medical Oncology Centre of Rosebank, Johannesburg, Gauteng, South Africa
Eastleigh Breast Care Center, Pretoria, Gauteng, South Africa
Sandton Oncology Centre, Johannesburg, , South Africa
Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Affiliation: Eli Lilly and Company
Role: STUDY_DIRECTOR