EUCTR2008-006556-21-FR进行中（未招募）1 期
Randomized Phase III, Double-Blind, Placebo-Controlled Multicenter Trial of Everolimus in Combination with Trastuzumab and Paclitaxel, as First Line Therapy in Women with HER2 Positive Locally Advanced or Metastatic Breast Cancer
ovartis Pharma Service AG0 个研究点目标入组 719 人开始时间: 2009年6月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 719
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
入选标准
- •? Written informed consent must be obtained prior to any study-related procedures.
- •? Women =18 years old.
- •? Patients with an ECOG performance status of 0-1.
- •? Histologically or cytologically confirmed invasive breast carcinoma with local
- •recurrence or radiological evidence of metastatic disease. Local disease must
- •not be amenable to resection with curative intent.
- •? Patients fulfilling one of the following criteria are eligible to participate in this
- •Patients with measurable disease as per RECIST criteria.
- •Patients with bone lesions, lytic or mixed (lytic + sclerotic), in the absence of measurable disease as defined by RECIST criteria.
- •? HER2+ patients by local laboratory testing (IHC 3+ staining or in situ
- •hybridization positive).
- •? Patients fulfilling one of the following criteria are eligible to participate in this study:
- •Patient never treated with trastuzumab
- •Prior trastuzumab and/or chemotherapy (taxanes included) as neo-adjuvant or adjuvant treatment is discontinued > 12 months prior to randomization
- •? Prior treatment for breast cancer with endocrine therapy (adjuvant or metastatic settings) is allowed but should be discontinued at randomization. Patients treated with bisphosphonates at entry or who start bisphosphonates during study may continue this therapy during protocol treatment.
- •? Documentation of negative pregnancy test for patients of child bearing potential prior to enrollment within 7 days prior to randomization. Sexually active pre-
- •menopausal patients must use adequate contraceptive measures while on study.
- •? Patients must meet the following laboratory criteria within 21 days prior to
- •randomization:
- •Hematology:
- •Neutrophil count of = 1.5 10 9/L
- •Platelet count of =100 x10 9/L
- •Hemoglobin = 90 g/L
- •Biochemistry:
- •AST/SGOT and ALT/SGPT = 2.5 x upper limit of normal (ULN) (or < 5.0 x ULN
- •if the transaminase elevation is due to hepatic metastasis).
- •Total serum bilirubin = 1.5 x ULN [Patients with Gilbert Syndrome must
- •have total bilirubin < 3ULN].
- •INR = 2 x ULN
- •Fasting serum cholesterol = 300 mg/dl or 7.75 mmol/L and fasting
- •triglycerides = 2.5 x ULN (with lipid-lowering drugs permitted)
- •Serum creatinine = 1.5 x ULN
- •? Left ventricular ejection fraction assessment (echocardiogram or MUGA scan)
- •performed within 4 weeks prior to randomization, showing a LVEF value = LLN
- •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 mTOR inhibitors for the treatment of cancer.
- •? Anticancer therapy for locally advanced or metastatic breast cancer except for prior hormonal therapy. Patients who had a recurrence within 12 months weeks after end of trastuzumab and/or chemotherapy (taxanes included) as neo-adjuvant or adjuvant treatment prior to randomization are not eligible.
- •? Patients with only non-measurable lesions other than bone metastasis (e.g.
- •pleural effusion, ascites, etc.).
- •? Patients who have received radiotherapy to = 25% of the bone marrow within
- •the last 4 weeks prior to randomization; local radiotherapy is allowed.
- •? History of central nervous system metastasis.
- •? Impairment of gastrointestinal (GI) function or GI disease that may significantly
- •alter the absorption of oral everolimus.
- •? Active ulceration of the upper gastrointestinal tract.
- •? NCI Common Terminology Criteria for Adverse Events (CTCAE) v 3.0 peripheral
- •neuropathy = grade 2 at randomization.
- •? Active cardiac disease:
- •Angina pectoris that requires the use of anti-anginal medication,
- •Ventricular arrhythmias except for benign premature ventricular contractions,
- •Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication,
- •Conduction abnormality requiring a pacemaker,
- •Valvular disease with documented compromise in cardiac function,
- •Symptomatic pericarditis.
- •? History of cardiac dysfunction including any one of the following:
- •Myocardial infarction .
- •History of documented congestive heart failure (New York Heart Association functional classification III-IV),
- •Documented cardiomyopathy.
- •? Uncontrolled hypertension or history of poor compliance with an antihypertensive
- •? Known human immunodeficiency virus infection (HIV).
- •? Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled
- •diabetes mellitus, active untreated or uncontrolled infection, chronic obstructive or
- •chronic restrictive pulmonary disease including dyspnoea at rest from any cause)
- •that could cause unacceptable safety risks or compromise compliance with the
- •? Known hypersensitivity to any protocol treatment.
- •? Requirement for therapeutic doses of warfarin or equivalent.
- •? Clinically significant third space fluid accumulation.
- •? Pregnant (i.e., positive beta-human chorionic gonadotropin test) or breast feeding.
- •? Patients with other significant disease or disorders that, in the investigator’s
- •opinion, would exclude the patient from the study.
- •? Patients with inability to grant a reliable informed consent.
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