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-
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Time to failure of strategy (TFS)
研究概览
简要总结
To compare continuing bevacizumab + paclitaxel or switching to bevacizumab + endocrine maintenance therapy followed by bevacizumab + paclitaxel, after 1st line induction therapy with bevacizumab + paclitaxel in ER+HER2- advanced or metastatic breast cancer.
详细描述
This multicenter, randomized Phase II study of patients with advanced or metastatic estrogen receptor-positive human epidermal receptor type 2-negative breast cancer aims to compare two treatment strategies following induction therapy with 4-6 cycles of the combined use of weekly paclitaxel (wPTX) and bevacizumab (BV). In arm A, wPTX+BV is continued, while in arm B, wPTX is switched to maintenance endocrine therapy (hormone+BV) until disease progression, followed by wPTX+BV re-induction. The primary endpoint is time to failure of strategy, which is the time from randomization to a qualifying event (addition of a new agent not in the primary regimen, progressive disease during or after planned therapy, or death).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the breast
- •Female aged 20-75 years old at getting informed consent
- •HER2 negative disease (IHC 0/1+ or 2+ with FISH negative)
- •Documented estrogen receptor (ER) positive (>=1% by IHC)
- •Inoperative locally advanced or metastatic breast cancer at enrolment
- •Performance status (ECOG): 0-1 at enrolment
- •Life expectancy of at least 3 months from enrolment
- •No prior systemic therapy for recurrent breast cancer (excluding hormone therapy)
- •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
- •Patients with measurable lesion regarding with Response Evaluation Criteria in Solid Tumors(RECIST) criteria or who have evaluable lesion
- •Patients with only bone lesion will be acceptable if the osteolytic lesion has a measurable soft tissue component by MRI or CT
- •No influence on protocol treatment is considered in case prior therapy or examination.
- •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 white blood cell(WBC) count >= 3000 /mm3
- •Platelets >=10 x 10000 /mm3
- •Hb >= 9 g/dL
- •Total bilirubin <= 1.5 mg/dL
- •aspartate aminotransferase(AST) and alanine aminotransferase(ALT) <= 100 international unit(IU)/L
- •Serum creatinine <= 1.5 mg/dL
- •Urine dipstick for proteinuria <= 1+
- •Written informed consent signed by patients before completing any treatment related procedure
排除标准
- •Prior therapy with bevacizumab
- •Active infection requiring intrvenous antibiotics at enrollment or infection with active HBV and/or HCV.
- •Pregnancy, lactetion or in case of potentialy pregnancy women Not mind contraception in trial period.
- •Known hypersensitivity to bevacizumab or paclitaxel
- •History of hemoptysis (>= 2.5mL of bright red blood per episord).
- •Use of disulfiram,cyanamide, carmofur or procarbazine Hydrochloride
- •Patients with CNS metastases (except for not symptomatic)
- •Persistent Grade >= 2 sensory neuropathy at enrollment
- •Grade 3 >= hypertension (>= 2 use of antihypertensive drug)
- •Evidence with arterial thromboembolism (Cerebral infarction, Myocardial infarction) or history within 1 year prior to enrollment.
- •Evidence withvenous thromboembolism (deep vein thrombosis, pulmonary embolism) or history within 1 year prior to enrollment.
- •History of GI perforation and/or serious abdominal fistula within 1 year prior to enrollment
- •Cases that the investigator judged as inappropriate as the subject of this clinical study
研究组 & 干预措施
Arm A
weekly paclitaxel + bevacizumab
干预措施: Paclitaxel (Drug)
Arm A
weekly paclitaxel + bevacizumab
干预措施: Bevacizumab (Drug)
Arm B
endocrine therapy* + bevacizumab then back to weekly paclitaxel + bevacizumab therapy
(*Letrozole, Anastrozole, Exemestane, Fulvestrant, LHRH Analogs + Aromatase inhibitors.)
干预措施: Paclitaxel (Drug)
Arm B
endocrine therapy* + bevacizumab then back to weekly paclitaxel + bevacizumab therapy
(*Letrozole, Anastrozole, Exemestane, Fulvestrant, LHRH Analogs + Aromatase inhibitors.)
干预措施: Bevacizumab (Drug)
Arm B
endocrine therapy* + bevacizumab then back to weekly paclitaxel + bevacizumab therapy
(*Letrozole, Anastrozole, Exemestane, Fulvestrant, LHRH Analogs + Aromatase inhibitors.)
干预措施: Letrozole (Drug)
Arm B
endocrine therapy* + bevacizumab then back to weekly paclitaxel + bevacizumab therapy
(*Letrozole, Anastrozole, Exemestane, Fulvestrant, LHRH Analogs + Aromatase inhibitors.)
干预措施: Anastrozole (Drug)
Arm B
endocrine therapy* + bevacizumab then back to weekly paclitaxel + bevacizumab therapy
(*Letrozole, Anastrozole, Exemestane, Fulvestrant, LHRH Analogs + Aromatase inhibitors.)
干预措施: Exemestane (Drug)
Arm B
endocrine therapy* + bevacizumab then back to weekly paclitaxel + bevacizumab therapy
(*Letrozole, Anastrozole, Exemestane, Fulvestrant, LHRH Analogs + Aromatase inhibitors.)
干预措施: Fulvestrant (Drug)
Arm B
endocrine therapy* + bevacizumab then back to weekly paclitaxel + bevacizumab therapy
(*Letrozole, Anastrozole, Exemestane, Fulvestrant, LHRH Analogs + Aromatase inhibitors.)
干预措施: Goserelin (Drug)
Arm B
endocrine therapy* + bevacizumab then back to weekly paclitaxel + bevacizumab therapy
(*Letrozole, Anastrozole, Exemestane, Fulvestrant, LHRH Analogs + Aromatase inhibitors.)
干预措施: leuprorelin (Drug)
结局指标
主要结局
Time to failure of strategy (TFS)
时间窗: 2.5 years
次要结局
- Safety(Collection of adverse events)(2.5years)
- 2y Overall Survival rate(3.5 years)
- QOL(2.5years)
- Overall Survival(3.5years)
- Biomarker(IMPACT assay Chips, whole blood, tumor tissue, Serum)(2.5years)
- Progression Free Survival(PFS)(2.5years)