Cohort Study of Prospective Validation of Predictive Factors and Biological Imaging of Response to Bevacizumab (AVASTIN ®) in Combination With Weekly Paclitaxel Chemotherapy in First Line Treatment Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 510
- 试验地点
- 18
- 主要终点
- Measure of the initial rates and changes in CEC / CLC (Biological study) and measure of the visceral fat (imaging study) as predictors of progression-free survival (PFS) and response to bevacizumab and paclitaxel
研究概览
简要总结
Bevacizumab plus chemotherapy improves response rates and prolongs PFS when used as first- and second-line therapy for advanced breast cancer. However, bevacizumab has not improved OS in the individual studies currently reported. In Europe, EMA has maintained its indication associated with weekly paclitaxel in first line metastatic breast cancer and more recently with capecitabine based on RIBBON 1 trial's results.
The identification of patient subsets that receive the most clinical benefit would enable more specific treatment administration of bevacizumab and allow patients unlikely to benefit the opportunity to seek other treatment modalities. Unfortunately, despite efforts to identify patient subsets with a differential benefit from bevacizumab, no validated biomarkers have been defined.
The Avastin cohort is a unique opportunity to investigate various biological and imaging parameters which could be related to clinical benefit of the combination of bevacizumab and weekly paclitaxel in first line metastatic breast cancer in a homogeneously treated population in French cancer centers. This trial will gather the expertise of several translational research platforms of different cancer centers from the UNICANCER consortium.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥18 years old.
- •Histologically confirmed breast adenocarcinoma, metastatic (measurable or unmeasurable lesion), HER2 negative (on the last tumor tissue analyzed), Patient to receive first-line chemotherapy paclitaxel and bevacizumab in a weekly manner as recommended by the EMEA.
- •Hormone receptor status known
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Life expectancy ≥12 weeks.
- •Women of childbearing age (except amenorrhea of at least 24 months) must have a negative pregnancy test serum within 28 days before starting treatment. In the absence of serum test, a urine pregnancy test (within 7 days before the first dose of bevacizumab) is required.
- •Informed consent form duly signed and dated by patient
排除标准
- •Prior chemotherapy for metastatic disease ;
- •Concomitant hormone therapy
- •The patient must not have undergone radiation therapy for the treatment of metastatic disease (except cases of analgesic radiotherapy for bone pain due to metastases).
- •Pregnant or nursing woman or woman of childbearing age (except amenorrhea for at least 24 months) who does not use an effective nonhormonal contraceptive method (intrauterine device, barrier method associated with the use of a spermicidal gel or surgical castration) for the duration of the study and 6 months after paclitaxel administration and / or bevacizumab.
- •Man who does not accept to use effective contraception during the study period and 6 months after paclitaxel administration and / or bevacizumab.
- •Known hypersensitivity to paclitaxel and / or to bevacizumab or to any excipients.
- •Patient unable to undergo medical test for geographical, social or psychological reasons.
- •Patient deprived of liberty or placed under the authority of a tutor
研究组 & 干预措施
Cohort
first line treatment for metastatic breast cancer
干预措施: Bevacizumab (Drug)
Cohort
first line treatment for metastatic breast cancer
干预措施: paclitaxel (Drug)
结局指标
主要结局
Measure of the initial rates and changes in CEC / CLC (Biological study) and measure of the visceral fat (imaging study) as predictors of progression-free survival (PFS) and response to bevacizumab and paclitaxel
时间窗: 2 years
次要结局
- Quality of Life assessment(2 years)
- Identification of new biomarkers as predictive factors of progression free survival (PFS), overall survival (OS) and of response to bevacizumab and paclitaxel.(2 years)
- The Biomarkers selected from our biological, proteomic and pharmacogenetic studies will be correlated to the safety.(2 years)