EUCTR2006-003291-35-IT进行中（未招募）不适用
Phase II, open label, neoadjuvant study of Bevacizumab in patients with inflammatory or locally advanced breast cancer - ND
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ROCHE
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
- •Patients with histologically proven stage III, or inflammatory breast cancer Female patients >18 years ER/PgR positive or negative and HER-2 negative patients No treatment with previous chemotherapy/endocrine therapy Performance status 0-1 (ECOG scale) No evidence of distant metastatic disease No other primary tumors within the last 5 years prior to enrolment, except for adequately treated carcinoma in situ of the cervix or basal cell skin cancer. No significant concomitant illness such as diabetes, cardiovascular, renal, or neurological impairments Absence of psychiatric illness undermining a correct understanding of the treatment program WBC >3,000/mm3; Neutrophils >2,000/mm3; Platelets >100,000/mm3; Haemoglobin >9 g/dL AST, ALT, gamma-GT <2.5 x upper normal limit and bilirubin <1.5 mg/dl Urine dipstick of proteinuria <2+. Patients discovered to have >2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate <1 g of protein/24hr. Creatinine <140 µmol/l (1.6 mg/dl); if bordeline limit values, the creatinine clearance should be >60 ml/min (actual or calculated by Cockcroft-Gault method) The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR, or appropriate monitoring test is within therapeutic limits and the patient has been on a stable dose of anticoagulants for at least two weeks at the time of enrolment. Patients not receiving anti coagulant medication must have an INR <1.5 and aPTT <1.5 x ULN within 7 days of enrolment. Normal left ventricular ejection fraction (LVEF) (evaluated by echocardiography or MUGA scan). The results must be above the upper limit of normal for the institution. Institutional Signed Written Informed Consent obtained
- •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
- •Primary breast cancer with histology other than adenocarcinoma. Primary breast carcinoma with any stage other than III. Patients with other non-malignant uncontrolled systemic diseases that would preclude trial entry in the opinion of the investigator. History or evidence or inherited bleeding diathesis or coagulopathy with the risk of bleeding Chronic daily treatment with aspirin (>325 mg/day) or clopidogrel (>75 mg/day) Serious non-healing wound, peptic ulcer, or bone fracture Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to enrolment, or minor surgical procedures, within 24 hours prior to enrolment History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of enrolment Clinical grade greater than or equal to 2 peripheral neuropathy Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start. Patients who are receiving other investigational drugs
研究者
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