A Phase 2 Study of Gemcitabine and Bevacizumab as First-Line Treatment in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer Previously Treated With Taxanes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS) Time
研究概览
简要总结
To determine how long Gemcitabine and Bevacizumab will stop the cancer from growing in patients with advanced breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Must be female and greater than or equal to 18 yrs of age
- •Participants must have confirmed cancer with measurable or evaluable, locally recurrent or metastatic disease.
- •Participants must have received a taxane as neo-adjuvant and/or adjuvant therapy
- •Participants may have received prior hormone therapy for locally recurrent or metastatic disease
排除标准
- •Participants with breast cancer overexpressing Human Epidermal growth factor Receptor 2 (HER2) gene amplification
- •Prior chemotherapy or targeted therapy for metastatic breast cancer
- •Prior treatment with gemcitabine, trastuzumab, lapatinib or bevacizumab in any setting
- •History of, or active brain mets
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to treatment, or anticipation of need for major surgical procedure during course of study
- •Prior history of high blood pressure crisis
- •Have a serious, nonhealing wound, ulcer, or bone fracture
研究组 & 干预措施
Gemcitabine + Bevacizumab
Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.
Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity.
干预措施: Gemcitabine (Drug)
Gemcitabine + Bevacizumab
Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.
Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity.
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Progression Free Survival (PFS) Time
时间窗: Baseline to measured PD or death from any cause. Tumor assessments were performed every 8 weeks during therapy and every 2 months during post-therapy until documented PD (up to 34 months).
PFS was measured from date of first dose to first date of progressive disease (PD) or death from any cause. For each participant who was not known to have died or to have had PD as of the data inclusion cut-off date for a particular analysis, PFS duration was censored for that analysis at the date of the participant's last progression-free tumor assessment before that cut-off date.
次要结局
- Overall Tumor Response Rate (ORR)(Baseline to measured PD. Tumor assessments were performed every 8 weeks (q 8 weeks) during therapy and q 2 months during post-therapy until documented PD (up to 34 months).)
- Number of Participants With Adverse Events (AEs); Pharmacology Toxicities(Baseline, every cycle (every 14 days) up to 34 months)
- 1-Year Overall Survival (OS) Rate(Baseline to death from any cause, 1 year)