A phase II randomised study to evaluate alpelisib plus fulvestrant versus capecitabine in oestrogen receptor positive, HER2-negative advanced breast cancer patients with PIK3CA mutant circulating DNA (BCT 1901 CAPTURE)

THIS DATASET IS NOT YET AVAILABLE FOR SHARING. Dataset of 58 participants with oestrogen receptor positive, HER2 negative advanced breast cancer and PIK3CA mutant circulating DNA who are randomised to evaluate treatment with alpelisib plus fulvestrant compared with capecitabine on progression free survival. The experimental arm is alpelisib at a dose of 300 mg administered by oral tablet once daily on a continuous dosing schedule starting on Cycle 1 Day 1 in combination with fulvestrant 500 mg intramuscular every 28 days. The comparator arm is capecitabine at a dose of 1000 mg/m^2 administered by oral tablet twice daily on Day 1 to 14 of a 21 day cycle. the primary endpoint is progression free survival (PFS) measured as per RECIST 1.1. Cancer Australia demographic data has been collected including: Age, Postcode of usual residence, Race/Ethnicity, CALD status (Country of Birth, Main language other than English used as the principle means of communication).

本数据集暂未开放共享。本数据集纳入58名雌激素受体阳性、人表皮生长因子受体2（HER2）阴性且携带PIK3CA突变循环DNA的晚期乳腺癌受试者，受试者被随机分组，以对比阿培利司（alpelisib）联合氟维司群（fulvestrant）与卡培他滨（capecitabine）的治疗方案对无进展生存期（Progression Free Survival, PFS）的影响。试验组给药方案为：阿培利司（alpelisib）300mg，口服片剂，每日1次，持续给药，自第1周期第1日开始，联合氟维司群（fulvestrant）500mg，肌内注射，每28日1次。对照组给药方案为：卡培他滨（capecitabine）1000mg/m²，口服片剂，每日2次，每21天为1个周期，于每个周期的第1至14日给药。主要终点为按实体瘤疗效评价标准1.1版（Response Evaluation Criteria in Solid Tumors 1.1, RECIST 1.1）评估的无进展生存期（PFS）。本研究已收集澳大利亚癌症委员会（Cancer Australia）相关人口统计学数据，涵盖年龄、常住地邮政编码、种族/族裔、文化与语言多元群体（Culturally and Linguistically Diverse, CALD）状态，具体包括出生国家、以非英语语言作为主要沟通媒介的主要语言。