EUCTR2014-005490-37-ES进行中（未招募）不适用
A PHASE III, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED STUDY OF ATEZOLIZUMAB (ANTI?PD-L1 ANTIBODY) IN COMBINATION WITH NAB-PACLITAXEL COMPARED WITH PLACEBO WITH NAB-PACLITAXEL FOR PATIENTS WITH PREVIOUSLY UNTREATED METASTATIC TRIPLE-NEGATIVE BREAST CANCER
Roche Farma S.A. que representa en España a F. Hoffmann-La Roche Ltd0 个研究点目标入组 350 人开始时间: 2016年2月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •? Women aged ? 18 years
- •? Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
- •? No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
- •? Representative FFPE tumor specimens in paraffin blocks (preferred) or at least
- •15 unstained slides, with an associated pathology report documenting ER, PR, and HER2 negativity
- •?A tumor specimen obtained from metastatic or locally advanced disease (if applicable) must be submitted if clinically feasible
- •? ECOG performance status of 0 or 1
- •? Life expectancy ? 12 weeks
- •? Measurable disease, as defined by RECIST v1.1
- •?Adequate hematologic and end-organ function defined by laboratory results obtained within 2 weeks prior to first study treatment.
- •?Women of child bearing potential must agree to use adequate contraception (double barrier
- •methods of birth control or abstinence) prior to study entry, for the duration of study treatment, and for 90 days after the last dose of study treatment.
- •? Patients who are not postmenopausal (? 12 months of non?therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of study drug
- •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 228
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 122
排除标准
- •? Spinal cord compression not definitively treated with surgery and/or radiation, or previously
- •diagnosed and treated spinal cord compression without evidence that disease has been
- •clinically stable for > 2 weeks prior to randomization
- •? Known CNS disease, except for treated asymptomatic CNS metastases
- •? Leptomeningeal disease
- •? Uncontrolled pleural effusion, pericardial effusion, or ascites (indwelling drainage catheters are permitted)
- •? Uncontrolled tumor-related pain
- •? Uncontrolled hypercalcemia
- •?Pregnancy or lactation
- •? Evidence of significant uncontrolled concomitant disease that could affect compliance with
- •the protocol or interpretation of results, including significant liver disease (such as cirrhosis,
- •uncontrolled major seizure disorder, or superior vena cava syndrome)
- •? Significant cardiovascular disease
- •? Severe infection within 4 weeks prior to randomization, including but not limited to
- •hospitalization for complications of infection, bacteremia, or severe pneumonia
- •? History of autoimmune disease (Autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and Type 1 diabetes mellitus on an stable insulin regimen may be eligible for this study)
- •? Prior allogeneic stem cell or solid organ transplantation
- •? History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis,
- •organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or
- •evidence of active pneumonitis on screening chest CT scan.
- •History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- •? Positive test for HIV
- •? Active hepatitis B or hepatitis C
- •?Active tuberculosis
- •?Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to randomization, or anticipated requirement for systemic immunosuppressive medications during the trial.
- •Low dose steroids for nausea, adrenocortical insufficiency or orthostatic hypotension, IV contrast allergic reactions and inhaled corticosteroids are permitted.
研究者
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