A Phase II Open-label, 2-Part, Multi-center Study of BYL719 (Alpelisib) in Combination With Fulvestrant for Men and Postmenopausal Women With PIK3CA Mutation Hormone Receptor (HR) Positive, HER2-negative, Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor (AI) Treatment in Japan

ovartis Pharma. K.K.0 个研究点目标入组 50 人开始时间: 2020年8月25日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Japanese man or postmenopausal woman
•- Participant has adequate tumor tissue for the analysis of PIK3CA mutational status by a Novartis designated laboratory.
•- Participant has identified PIK3CA mutation (as determined by a Novartis designated laboratory)
•- Participant has a histologically and/or cytologically confirmed diagnosis of ER+ and/or PgR+ breast cancer by local laboratory
•- Participant has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH or SISH) test is required by local laboratory testing
•- Participant has measurable disease, i.e., at least one measurable lesion as per RECIST 1.1
•- Participant has advanced breast cancer
•- Participant has ECOG performance status 0 or 1

•- Participant with symptomatic visceral disease or any disease burden that makes the participant ineligible for endocrine therapy per the investigator's best judgment
•- Participant has received prior treatment;
•with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, any PI3K, mTOR or AKT inhibitor for Cohort 1 and 3 with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, any PI3K, mTOR, AKT inhibitor or CDK 4/6 inhibitor for Cohort 2
•- Participant has a known hypersensitivity to alpelisib or fulvestrant, or to any of the excipients of alpelisib or fulvestrant
•- Participant with inflammatory breast cancer at screening
•- Participant is concurrently using other anti-cancer therapy
•- Participant has had surgery within 14 days prior to starting study drug or has not recovered from major side effects
•- Participant with an established diagnosis at screening of diabetes mellitus type I or not controlled type II (based on FPG and HbA1c)
•- Participant has currently documented pneumonitis /interstitial lung disease
•- History of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis
•- Participant with unresolved osteonecrosis of the jaw
•- Participant has a history of severe cutaneous reactions

发起方

ovartis Pharma. K.K.