EUCTR2011-005932-24-AT
进行中（未招募）
不适用
A randomized, double-blind, placebo controlled, phase II/III study of BKM120 plus paclitaxel in patients with HER2 negative inoperable locally advanced or metastatic breast cancer, with or without PI3K pathway activation.
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- ovartis Pharma Services AG
- 入组人数
- 524
- 状态
- 进行中（未招募）
- 最后更新
- 10年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •\- Breast cancer that is locally advanced or metastatic
- •\- HER2 negative disease, and a known hormone receptor status (common breast cancer classification tests)
- •\- A tumor sample must be shipped to a central lab for identification of biomarkers (PI3K activation status) before randomization
- •\- Adequate bone marrow and organ function
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
排除标准
- •\- Prior chemotherapy for locally advanced or metastatic disease
- •\- Previous treatment with PI3K inhibitors
- •\- Symptomatic brain metastases
- •\- Concurrent malignancy or malignancy within 3 years prior to start of study treatment
- •\- Certain drugs or radiation within 2\-4 weeks of enrollment
- •\- Increasing or chronic treatment (\> 5 days) with corticosteroids or another immunosuppressive agent
- •\- Active heart (cardiac) disease as defined in the protocol
- •\- Sensitivity to paclitaxel treatment or inability to use the paclitaxel standard pre\-treatment such as corticosteroids
- •\- Pregnant or nursing (lactating) woman
- •\- Certain scores on an anxiety and depression mood questionaire given at screening
结局指标
主要结局
未指定
相似试验
已完成
3 期
A randomized, double-blind, placebo controlled, phase II/III study of BKM120 plus paclitaxel in patients with HER2 negative inoperable locally advanced or metastatic breast cancer, with or without PI3K pathway activation.NL-OMON39231ovartis Pharma BV10
进行中（未招募）
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A study of the experimental drug BKM120 with paclitaxel in patients with HER2 negative, locally advanced or metastatic breast cancer, with or without PI3K activatioThis study will evaluate whether the addition of daily BKM120 to weekly paclitaxel is effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer.MedDRA version: 14.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2011-005932-24-HUovartis Pharma Services AG524
进行中（未招募）
不适用
A study of the experimental drug BKM120 with paclitaxel in patients with HER2 negative, locally advanced or metastatic breast cancer, with or without PI3K activatioThis study will evaluate whether the addition of daily BKM120 to weeklypaclitaxel is effective and safe in treating patients with HER2- locallyadvanced or metastatic breast cancer.MedDRA version: 15.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2011-005932-24-ITOVARTIS FARMA200
进行中（未招募）
不适用
A study of the experimental drug BKM120 with paclitaxel in patients with HER2 negative, locally advanced or metastatic breast cancer, with or without PI3K activatioThis study will evaluate whether the addition of daily BKM120 to weekly paclitaxel is effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer.MedDRA version: 17.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2011-005932-24-DEovartis Pharma Services AG524
进行中（未招募）
不适用
A study of the experimental drug BKM120 with paclitaxel in patients with HER2 negative, locally advanced or metastatic breast cancer, with or without PI3K activatioEUCTR2011-005932-24-ESovartis Farmacéutica S.A.200