EUCTR2008-003006-34-NO进行中（未招募）1 期
A multicenter, randomized, phase II clinical trial to evaluate the effect of Avastin in combination with neoadjuvant treatment regimens on the molecular and metabolic characteristics and changes in the primary tumors with reference to the obtained responses in patients with large primary HER2 negative breast cancers. - Neo-Ava
Oslo Universitetssykehus0 个研究点目标入组 200 人开始时间: 2008年5月21日最近更新:
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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
- 200
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
- 性别
- All
入选标准
- •1. Written informed consent (informed consent document to be approved by the Independent Ethics Committee [IEC]) obtained prior to any study-specific procedure
- •2. Female or male age =18 years
- •3. Able to comply with the protocol
- •4. Histologically or cytologically confirmed, HER2-negative, men or pre- or post-menopausal women with primary operable adenocarcinoma of the breast, more than 2.0 cm in size
- •5. ECOG/WHO performance status = 2
- •6. Adequate haematological function
- •- Absolute neutrophil count (ANC) =1.0 x 109/L
- •- Platelet count =100 x 109/L
- •- Haemoglobin =9 g/dL (may be transfused to maintain or exceed this level)
- •7. Adequate liver function
- •- Total bilirubin <1.5 x upper limit of normal (ULN)
- •- AST, ALT <2.5 x ULN
- •8. Adequate renal function
- •- Serum creatinine =1.25 x ULN or calculated creatinine clearance =50 mL/min
- •- Urine dipstick for 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 in 24 hours
- •9. Normal base line cardiac function (LVEF) as measured by MUGA or ECHO
- •10. International normalized ratio (INR) =1.5 and PTT =1.5 x ULN within 7 days prior to enrolment
- •11. Women should not be pregnant or breast-feeding. Women with an intact uterus (unless amenorrhoeic for the last 24 months) must have a negative serum pregnancy test within 28 days prior to inclusion into the study. If a serum pregnancy test is not performed within 7 days prior to the first dose of bevacizumab, a confirmatory urine test (within 7 days prior to the first dose of bevacizumab) is required
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Stage IV (metastatic disease).
- •2. Previous treatment for localized breast cancer (chemotherapy, radiotherapy or hormonal treatment) less than 24 months from the diagnosis of the present breast cancer.
- •3. Other earlier or concomitant carcinoma, exept for BCC, in situ cervix cancer or breast cancer
- •4. Major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment or anticipation of the need for major surgery during study treatment
- •5. Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion
- •6. Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (>325 mg/day)
- •7. Current or recent (within 10 days of first dose of bevacizumab) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed
- •8. History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
- •9. Uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg)
- •10. Clinically significant (i.e. active) cardiovascular disease for example CVA (=6 months before enrolment), myocardial infarction (=6 months before enrolment), unstable angina, congestive heart failure (CHF) NYHA Class =II, serious cardiac arrhythmia requiring medication during the study, which might interfere with regularity of the study treatment, or not controlled by medication
- •11. Non-healing wound, active peptic ulcer or bone fracture
- •12. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment
- •13. Women with an intact uterus (unless amenorrhoeic for the last 24 months) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) during the study and for a period of 6 months following the last administration of bevacizumab.
- •14. Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment
- •15. Known hypersensitivity to bevacizumab and any of its excipients, and any of the chemotherapies
- •16. Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications
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