Spots Global Cancer Trial Database for Efficacy and Safety of Ribociclib in Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer.
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Trial Identification
Brief Title: Efficacy and Safety of Ribociclib in Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer.
Official Title: Phase II Randomized, Double-blind, Placebo-controlled Study of LEE011(Ribociclib) or Placebo in Combination With Endocrine Therapy for the Treatment of Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer, Including a Subset With Pharmacokinetic Analysis.
Study ID: NCT03671330
Conditions
Study Description
Brief Summary: This is a Phase II randomized, double-blind, placebo-controlled study involving premenopausal and postmenopausal Chinese women plus an open-label single arm of pharmacokinetic cohort of LEE011 in combination with Letrozole in Chinese postmenopausal women with HR+, HER2- negative advanced breast cancer. Three cohorts of patients will be enrolled: PK cohort, premenopausal cohort, and postmenopausal cohort.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Novartis Investigative Site, Hefei, Anhui, China
Novartis Investigative Site, Chongqing, Chongqing, China
Novartis Investigative Site, Guangzhou, Guangdong, China
Novartis Investigative Site, Shijiazhuang, Hebei, China
Novartis Investigative Site, Harbin, Heilongjiang, China
Novartis Investigative Site, Changsha, Hunan, China
Novartis Investigative Site, Nanjing, Jiangsu, China
Novartis Investigative Site, Suzhou, Jiangsu, China
Novartis Investigative Site, Nanchang, Jiangxi, China
Novartis Investigative Site, Chang Chun, Jilin, China
Novartis Investigative Site, Shengyang, Liaoning, China
Novartis Investigative Site, Shengyang, Liaoning, China
Novartis Investigative Site, Xian, Shanxi, China
Novartis Investigative Site, Chengdu, Sichuan, China
Novartis Investigative Site, Kunming, Yunnan, China
Novartis Investigative Site, Hangzhou, Zhejiang, China
Novartis Investigative Site, Hangzhou, Zhejiang, China
Novartis Investigative Site, Beijing, , China
Novartis Investigative Site, Beijing, , China
Novartis Investigative Site, Fuzhou, , China
Novartis Investigative Site, Qingdao, , China
Novartis Investigative Site, Shanghai, , China
Novartis Investigative Site, Shanghai, , China
Novartis Investigative Site, Tianjin, , China
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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