EUCTR2009-014279-37-GB进行中（未招募）1 期
Open-Label study of bevacizumab (Avastin®) and taxane monotherapy for the first-line treatment of patients with advanced triple-negative breast cancer - BATMA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 49
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
- All
入选标准
- •1. Written informed consent obtained prior to any study specific procedure.
- •2. Age =18 years.
- •3. Histologically confirmed, triple-negative (ER-/PgR-/HER2-) adenocarcinoma of the breast in pre- or post-menopausal women with measurable or non-measurable metastatic disease.
- •4. Patient who in Investigator’s opinion requires combination therapy for their disease.
- •5. Performance status (PS) =60 measured by Karnofsky score (similar to ECOG PS 0-2).
- •6. Life expectancy of =12 weeks.
- •7. Prior adjuvant chemotherapy is allowed.
- •8. Prior radiation therapy is allowed if:
- •delivered in the adjuvant setting as a part of the treatment of early breast cancer
- •delivered for the relief of metastatic bone pain, provided that no more than 30% of marrow-bearing bone has been irradiated.
- •9. Adequate haematological function
- •Absolute neutrophil count (ANC) =1.5 x 109/L AND
- •Platelet count =100 x 109/L AND
- •Haemoglobin =9 g/dL (may be transfused to maintain or exceed this level).
- •10. Adequate liver function
- •Total bilirubin <1.5 x upper limit of normal (ULN) AND
- •AST, ALT <2.5 x ULN in patients without liver metastases; <5 x ULN in patients with liver metastases.
- •11. Adequate 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 should have a 24 hour urine collection and must show =1 g of protein in 24 hours.
- •12. International normalised ratio (INR) =1.5 and partial prothrombin time (PTT or aPTT) =1.5 x ULN within 7 days prior to enrolment.
- •13. Patients should not be pregnant or breast-feeding. Women of child-bearing potential (i.e. a woman who is capable of becoming pregnant) must have a negative serum or urine pregnancy test within 7 days prior to first dose of bevacizumab. Patients must agree to use contraception throughout the study and for 6 months after the last dose of bevacizumab. Women must discontinue breast-feeding during therapy and not breast feed for at least 6 months following the last dose of Avastin.
- •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 metastatic breast cancer.
- •2. Patients currently undergoing radiation therapy for the treatment of metastatic disease (apart from therapy for the relief of metastatic bone pain).
- •3. Pre-existing peripheral neuropathy NCI CTC-AE Grade >2.
- •4. Major surgery (including open biopsy) or 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) use of aspirin (>325 mg/day).
- •7. Current or recent (within 10 days) use of full-dose 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. Active cardiovascular disease =6 months before enrolment, e.g. CVA or myocardial infarction, or unstable angina or congestive heart failure NYHA Class =II not controlled by medication.
- •11. History of thrombotic disorders within the six months prior to enrolment.
- •12. Non-healing wound, active peptic ulcer or bone fracture.
- •13. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to enrolment.
- •14. Women with an intact uterus (unless amenorrhoeic for the last 24 months) not using effective, non-hormonal means of contraception during the study and 6 months after the last dose of bevacizumab.
- •15. Known hypersensitivity to bevacizumab or any of its excipients or paclitaxel.
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