PER-071-06已完成未知
COMPARATIVE, PHASE III, MULTICENTER, RANDOMIZED STUDY WITH A GROUP WITH A PLACEBO TO EVALUATE THE EFFECTIVENESS AND SAFETY OF BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY REGIMES IN PATIENTS WITH BREAST METASTASIC CANCER WITHOUT PREVIOUS TREATMENT
PRODUCTOS ROCHE Q.F.S.A.,0 个研究点目标入组 0 人开始时间: 2006年10月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1) Measurable or non-measurable breast adenocarcinoma, recurrent localized or metastatic disease, cytologically or histologically confirmed.
- •2) Have signed the Informed Consent.
- •3) Age ≥ 18 years.
- •4) Women with potential fertility will be required to use an accepted and effective non-hormonal contraceptive method.
- •5) A general state EGOG 0 or 1.
- •6) Be able to comply with the study and follow-up procedures.
- •7) Only for the anthracycline cohort: adequate left ventricle function at the beginning of the study.
- •8) For patients who have recently received radiation therapy: recovery of any important acute toxicity before day 0.
排除标准
- •1) Unknown condition of HER2, or known positive HER2.
- •2) A treatment prior to the study with chemotherapy for recurrent or metastatic disease.
- •3) A previous hormonal treatment within 2 weeks prior to day 0.
- •4) Complementary or pre-surgical prior chemotherapy within 12 months prior to day 0.
- •5) Only for the anthracycline cohort: treatment with anterior anthracycline as part of a complementary or pre-surgical treatment for localized breast cancer.
- •6) Experimental treatment within 28 days of day 0.
- •7) Major surgery, open biopsy, or major traumatic injury within 28 days prior to day 0, or anticipate the need for major surgery during the course of the study.
- •8) Minor surgeries, such as fine needle punctures or thick needle biopsies, within 7 days prior to day 0.
- •9) Brain metastases or other known CNS.
- •10) Blood pressure> 150/100 mmHg.
- •11) Unstable angina.
- •12) CHF grade II or higher.
- •13) Antecedents of myocardial infarction within 6 months prior to day 0.
- •14) History of cerebrovascular accident or transient ischemic attack within 6 months prior to day 0.
- •15) Symptomatic peripheral vascular disease.
- •16) Evidence of hemorrhagic diathesis or coagulopathies.
- •17) History of abdominal fistula, gastrointestinal perforation or intrabdominal abscess within 6 months prior to day 0.
- •18) Severe unhealed wounds, ulcers or bone fractures.
- •19) Pregnancy or lactation.
- •20) Inadequate organic functioning according to laboratory values.
- •21) Uncontrolled serious medical or psychiatric diseases.
- •22) Active infection requiring IV antibiotics on day 0.
- •23) Antecedents of other malignancies within the 5 years prior to day 0.
研究者
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