EUCTR2010-022065-10-SE进行中（未招募）不适用
Effect of angiogenesis inhibiting therapy in patients progressing on endocrine treatment and patients with triple negative breast cancer - a translational phase II study within theSwedish Association of Breast Oncologists SABO-2010-01
Sahlgrenska University Hospital0 个研究点开始时间: 2011年2月25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
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
- •1.Written informed consent approved by the Independent Ethical Board.
- •2.Female patients >18 years with breast cancer confirmed by histology.
- •3. Relapse (local or distant) and progress on 1st, 2nd or 3rd line endocrine therapy.
- •4.Measurable or evaluable disease. Locally advanced or metastatic TNBC
- •5. ECOG PS 0-2
- •6.Life expectancy of >3 months
- •6.Adequate bone marrow, renal, hepatic and cardiac functions and no other uncontrolled medical or psychiatric disorders.
- •Haematologic function
- •Absolute neutrophil count (ANC) = 1.5 x 109/L and
- •Platelet count = 100 x 109/L and
- •Haemoglobin = 9g /dL (transfusion allowed to reach this level)
- •Liver function
- •Total bilirubin <1.5 x upper limit of normal (ULN) and
- •AST, ALT <2.5 x ULN (patients without liver metastases)
- •AST, ALT <5 x ULN (patients with liver metastases)
- •Renal function
- •Serum creatinine = 1.25 x ULN or calculated creatinine clearance = 50 mL/min and
- •Urine dipstick for proteinuria < 2+. Patients with = 2+ proteinuria on dipstick analysis at baseline should undergo a 24 hour urine collection resulting in = 1g of protein in 24 hours.
- •International normalised ratio (INR) = 1.5 and PTT = 1.5 x UNL within 7 days prior to enrolment.
- •7.ECOG performance status 0-2.
- •8.Patients in child-bearing age must have adequate contraception.
- •9.Tumour and blood samples according to APPENDIX II available.
- •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
- •1. Previous chemotherapy for recurrent breast cancer (local or distant metastasis).
- •2. Symptoms of CNS metastases. If suspected, the patient should be scanned within 28 days prior to enrolment to rule out CNS metastases.
- •3. 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.
- •4. Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion.
- •5. Current or recent (within 10 days of first dose of bevacizumab) use of aspirin (>325 mg/day).
- •6. History or evidence of inherited bleeding diathesis or coagulapathy with the risk of bleeding.
- •7. Uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg).
- •8. Clinically significant (i.e. active) cardiovascular disease for example CVA (=6 months before enrolment), myocardial infarction (MI) (=6 months before enrolment), unstable angina, 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.
- •9. Non-healing wound, active peptic ulcer or bone fracture.
- •10. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment.
- •11. Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment.
- •12. 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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