A PHASE III, DOUBLE-BLIND,PLACEBO-CONTROLLED, RANDOMIZED STUDYOF IPATASERTIB IN COMBINATION WITHATEZOLIZUMAB AND PACLITAXEL AS ATREATMENT FOR PATIENTS WITH LOCALLYADVANCED UNRESECTABLE OR METASTATICTRIPLE-NEGATIVE BREAST CANCER.

F. Hoffmann La Roche Ltd / Genentech Inc,0 个研究点目标入组 9 人开始时间: 2019年8月28日最近更新: 2023年11月13日

研究概览

暂无简介。

•Signed Informed Consent Form(s)
•Women or men, age ≥ 18 years at the time of signing the Informed Consent Form
•Willingness and ability to complete all study-related assessments, including PRO assessments, in the investigator’s judgment.
•Measurable disease according to RECIST v1.1
•Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation.
•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
•Adequate hematologic and organ function within 14 days before the first study treatment on
•Day 1 of Cycle 1.
•Life expectancy of at least 6 months
•For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs.
•For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm.
•See protocol for more detail.

•Inability to comply with study and follow-up procedures
•History of malabsorption syndrome or other condition that would interfere with enteral
•absorption or results in the inability or unwillingness to swallow pills
•Active infection requiring systemic anti-microbial treatment (including antibiotics, anti-fungal agents, and anti-viral agents)
•Known HIV infection (there must be a negative HIV test at screening)
•Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis.
•Current treatment with anti-viral therapy for HBV
•Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to
•Day 1 of Cycle 1 or anticipation of need for a major surgical procedure during the study.
•Pregnancy or breastfeeding, or intention to become pregnant during the study or within 28 days after the final dose of ipatasertib/placebo, 5 months after the final dose of atezolizumab/placebo, and 6 months after the final dose of paclitaxel whichever occurs later.
•See protocol for more detail.

发起方

F. Hoffmann La Roche Ltd / Genentech Inc,