A PHASE III, DOUBLE-BLIND,PLACEBO-CONTROLLED, RANDOMIZED STUDY OF IPATASERTIB IN COMBINATION WITH ATEZOLIZUMAB AND PACLITAXEL AS A TREATMENT FOR PATIENTS WITH LOCALLY ADVANCED UNRESECTABLE OR METASTATIC TRIPLE-NEGATIVE BREAST CANCER

F HoffmannLa Roche Ltd0 个研究点目标入组 1 人开始时间: 待定最近更新: 2021年11月24日

研究概览

暂无简介。

•Informed Consent
•Woman or man age 18 years and above
•Inoperable locally advanced/metastatic breast cancer (LA/MBC), Histologically documented TNBC or HR+/HER2â?? adenocarcinoma and suitable for taxane monotherapy
•At least 12 month disease-free interval from last chemotherapy/radiation treatment for early BC.
•Eastern Cooperative Oncology Group Performance Status of 0 or 1
•Life expectancy of at least 6 months
•Measurable disease according to RECIST v1.1
•formalin-fixed, paraffin-embedded tumor (FFPE) tissue, [PIK3CA/AKT1/PTEN-altered status and central ctDNA]
•Adequate hematologic and organ function within 14 days before the first study treatment
•Fasting total serum glucose <= 150 mg/dL and HbA1C <= 7.5%,

•Active infection requiring systemic anti-microbial treatment, Known HIV infection, Active viral or other Hepatitis
•New York Heart Association Class II, III, or IV heart failure, LVEF less than 50%
•History of or known presence of brain or spinal cord metastases by CT/ MRI
•Any previous chemotherapy for inoperable locally advanced or metastatic TNBC or HR+/HER2â?? adenocarcinoma of the breast
•Uncontrolled pleural effusion, pericardial effusion, or ascites
•History of or active Inflammatory bowel disease, Lung disease
•Prior treatment with an AKT inhibitor (Prior PI3K or mTOR inhibitors are allowed)
•No uncontrolled disease/unresolved toxicity or clinically relevant condition which may contraindicate use of an investigational drug

发起方

F HoffmannLa Roche Ltd