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Brief Title: A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor
Official Title: A Randomized, Double-blind, Placebo Controlled, Phase II Study of Everolimus in Combination With Exemestane in the Treatment of Chinese Postmenopausal Women With Estrogen Receptor Positive, HER-2 Negative, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Prior Letrozole or Anastrozole
Study ID: NCT03312738
Brief Summary: This study aimed at evaluating the safety and efficacy of everolimus plus exemestane in Chinese postmenopausal women with ER+ HER2- locally advanced, recurrent, or metastatic breast cancer after recurrence or progression on letrozole or anastrozole.
Detailed Description: This was a multicenter, double-blind, randomized, placebo-controlled, phase II study evaluating treatment with everolimus (10 mg daily) in combination with exemestane (25 mg daily) vs placebo in combination with exemestane (25 mg daily) in Chinese postmenopausal women with locally advanced, recurrent or metastatic ER+ HER2- breast cancer refractory to non-steroidal aromatase inhibitors. Randomized participants started the study treatment at Cycle 1 Day 1, and were treated continuously until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death or discontinuation from treatment for any other reason. After end of treatment, all participants were followed up for safety up to 30 days after last dose of study treatment (exemestane and/or everolimus/placebo). All participants were followed for survival status at least every 3 months after treatment discontinuation unless they discontinued due to death, consent withdrawal or lost to follow-up If a participants permanently discontinued study treatment for reasons other than disease progression, death, lost to follow-up, or withdrawal of consent to efficacy follow-up then they entered the post-treatment efficacy follow-up period until disease progression, death, lost to follow-up or withdrawal of consent for efficacy follow-up.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Novartis Investigative Site, Guangzhou, Guangdong, China
Novartis Investigative Site, Harbin, Heilongjiang, China
Novartis Investigative Site, Wuhan, Hubei, China
Novartis Investigative Site, Nanjing, Jiangsu, China
Novartis Investigative Site, Shanghai, Shanghai, China
Novartis Investigative Site, Chengdu, Sichuan, China
Novartis Investigative Site, Chengdu, Sichuan, China
Novartis Investigative Site, Tianjin, Tianjin, China
Novartis Investigative Site, Hangzhou, Zhejiang, China
Novartis Investigative Site, Beijing, , China
Novartis Investigative Site, Chongqing, , China
Novartis Investigative Site, Guangzhou, , China
Novartis Investigative Site, Qingdao, , China
Novartis Investigative Site, Shanghai, , China
Novartis Investigative Site, Wuhan, , China
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR