JPRN-jRCTs021180026已完成2 期
Bevacizumab plus paclitaxel optimization study with interventional maintenance endocrine therapy in advanced or metastatic ER-positive HER2-negative breast cancer-BOOSTER trial, a multicenter randomized phase II study- - JBCRG-M04 (BOOSTER)
Saji Shigehira0 个研究点目标入组 160 人开始时间: 2019年3月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
研究概览
简要总结
The primary endpoint of TFS is significantly prolonged in the maintenance endocrine + BV group.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- Female
入选标准
- •1. Histologically confirmed adenocarcinoma of the breast
- •2. Female aged 20-75 years old at getting informed consent
- •3. HER2 negative disease (IHC 0/1+ or 2+ with FISH negative)
- •4. Documented estrogen receptor (ER) positive (>=1% by IHC)
- •5. Inoperative locally advanced or metastatic breast cancer at enrolment
- •6. Performance status (ECOG): 0-1 at enrolment
- •7. Life expectancy of at least 3 months from enrolment
- •8. No prior systemic therapy for recurrent breast cancer (excluding hormone therapy)
- •9. No prior neo and/or adjuvant chemotherapy with taxane or adjuvant setting with a disease-free interval from completion of the taxane treatment to metastatic diagnosis of >= 12 months
- •10. Patients with measurable lesion regarding with RECIST criteria or who have evaluable lesion
- •11. Patients with only bone lesion will be acceptable if the osteolytic lesion has a measurable soft tissue component by MRI or CT
- •12. No influence on protocol treatment is considered in case prior therapy or examination.
- •13. Adequate following organ function within 2 weeks before starting treatment. The latest examination results should be adopted and blood transfusion or treatment of hematopoietic factor drugs is not allowed 2 weeks before examination.
- •- Absolute neutrophil count >= 1500 /mm3 or WBC count >= 3000 /mm3
- •- Platelets >=10 x 10000 /mm3
- •- Hb >= 9 g/dL
- •- Total bilirubin <= 1.5 mg/dL(except for constitutional jaundice)
- •- AST and ALT <= 100IU/L (<=200IU/L if liver metastasis)
- •- Serum creatinine <= 1.5 mg/dL
- •-Urine dipstick for proteinuria <= 1+
- •14. Written informed consent signed by patients before conducting any treatment related procedure
排除标准
- •(1)Prior therapy with bevacizumab
- •(2) Active infection requiring intrvenous antibiotics at enrollment or infection with active HBV and/or HCV.
- •(3) Pregnancy, lactetion or in case of potentialy pregnancy women Not mind contraception in trial period.
- •(4) Known hypersensitivity to bevacizumab or paclitaxel
- •(5) History of hemoptysis (>= 2.5mL of bright red blood per episord).
- •(6) Use of disulfiram,cyanamide, carmofur or procarbazine Hydrochloride
- •(7) Patients with CNS metastases (except for not symptomatic)
- •(8) Persistent Grade >= 2 sensory neuropathy at enrollment
- •(9) Grade 3 >= hypertension (>= 2 use of antihypertensive drug)
- •10) Evidence with arterial thromboembolism
- •(Cerebral infarction, Myocardial infarction) or history within 1 year prior to enrollment.
- •(11) Evidence with venous thromboembolism (deep vein thrombosis, pulmonary embolism) or history within 1 year prior to enrollment.
- •(12) History of GI perforation and/or serious abdominal fistula within 1 year prior to enrollment
- •(13) Cases that the investigator judged as inappropriate as the subject of this clinical study
研究者
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