CTRI/2019/05/019047
招募中
3 期
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 â?? Positive, HER2 â?? Negative Breast Cancer
F HoffmannLa Roche Ltd0 个研究点目标入组 0 人待定
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- 发起方
- F HoffmannLa Roche Ltd
- 状态
- 招募中
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •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 \<\= 150Â mg/dL and HbA1C \<\=Â 7\.5%,
排除标准
- •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
结局指标
主要结局
未指定
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