A Double-Blind, Placebo-Controlled, Randomized Phase III Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Patients With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer

CHUGAI PHARMACEUTICAL CO., LTD.0 个研究点目标入组 450 人开始时间: 2017年11月14日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Eastern Cooperative Oncology Group Performance Status of 0 or 1
•- Adequate hematologic and organ function
•- Histologically documented triple-negative breast cancer (TNBC) or HR+/HER2- adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to resection with curative intent
•- HR+/HER2- breast cancer that is not considered appropriate for endocrine-based therapy and meets one of the following:
•*Patient has recurrent disease <=5 years of being on adjuvant endocrine therapy
•*If patient with de novo metastatic disease have progressed within 6 months of being on first line endocrine therapy
•- Measurable disease according to Response Evaluation Criteria in Solid Tumors(RECIST) v1.1
•- Valid results from either central testing or local testing confirming PIK3CA/AKT1/PTEN-altered status in tumor tissue or blood

•- Active infection requiring antibiotics
•- Known HIV infection
•- Known clinically significant history of liver disease consistent with Child Pugh Class B or C, including active viral or other hepatitis, current drug or alcohol abuse, or cirrhosis
•- History of or known presence of brain or spinal cord metastases
•- Any previous chemotherapy for inoperable locally advanced or metastatic TNBC or HR+/HER2- adenocarcinoma of the breast
•- History of Type I or Type II diabetes mellitus requiring insulin
•- Grade >= 2 uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia
•- History of or active inflammatory bowel disease
•- Prior treatment with an Akt inhibitor (prior PI3K or mTOR inhibitors are allowed)

发起方