An International Multi-centre Open-label 2-arm Phase III Trial of Adjuvant Bevacizumab in "Triple Negative" Breast Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,591
- 主要终点
- Time to Invasive Disease-free Survival (IDFS) Event Excluding Second Primary Non-Breast Invasive Cancer
研究概览
简要总结
The main objective of the trial is to compare Invasive Disease-Free Survival (IDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy with 1 year of bevacizumab.
The secondary objectives of this trial are to:
- compare Overall Survival (OS), Breast Cancer-Free Interval (BCFI), Disease- Free Survival (DFS) and Distant Disease-Free Survival (DDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy in combination with 1 year of bevacizumab
- evaluate the safety and tolerability of bevacizumab
An exploratory sub-study (not reported here) was to identify biomarkers (from tumour or serum) predictive of toxicity and for the level of benefit from the addition of bevacizumab to standard adjuvant systemic treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, >=18 years of age;
- •operable primary invasive breast cancer;
- •completed definitive loco-regional surgery;
- •primary tumor centrally confirmed as triple negative.
排除标准
- •locally advanced breast cancers;
- •previous breast cancer history;
- •clinically significant cardiovascular disease.
研究组 & 干预措施
Bevacizumab and Chemotherapy
Participants randomized to receive bevacizumab in combination with chemotherapy as prescribed.
干预措施: Bevacizumab (Drug)
Bevacizumab and Chemotherapy
Participants randomized to receive bevacizumab in combination with chemotherapy as prescribed.
干预措施: Standard adjuvant chemotherapy (Drug)
Chemotherapy
Participants randomized to receive standard adjuvant chemotherapy as prescribed.
干预措施: Standard adjuvant chemotherapy (Drug)
结局指标
主要结局
Time to Invasive Disease-free Survival (IDFS) Event Excluding Second Primary Non-Breast Invasive Cancer
时间窗: Event driven (until data cutoff: 29 February 2012: up to 49 months)
IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer.
Percentage of Participants With Invasive Disease-free Survival (IDFS) Events
时间窗: Event driven (until data cutoff: 29 February 2012 up to 49 months)
IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer. The percentage of participants with and without IDFS Events by the time of the data cutoff is presented.
Time to Invasive Disease-free Survival (IDFS) Event
时间窗: Event driven (until data cutoff: 29 February 2012: up to 49 months)
IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer.
Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer
时间窗: Event driven (until data cutoff: 29 February 2012: up to 49 months)
IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer. Percentage of participants with and without IDFS Events by the time of data cutoff is presented.
次要结局
- Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events(Event driven (until data cutoff: 29 February 2012: up to 49 months))
- Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths(Through end of study: 30 June 2014: up to 77 months)
- Percentage of Participants With Overall Survival (OS) Event(Event driven (until data cut off: 30 June 2014: up to 77 months))
- Time to Breast Cancer-Free Interval (BCFI) Event(Event driven (until data cutoff: 29 February 2012: up to 49 months))
- Time to Overall Survival (OS) Event(Event driven (until data cutoff: 30 June 2014: up to 77 months))
- Time to Disease-Free Survival (DFS) Event(Event driven (until data cutoff: 29 February 2012: up to 49 months))
- Percentage of Participants With Distant Disease-Free Survival (DDFS) Events(Event driven (until data cutoff: 29 February 2012: up to 49 months))
- Percentage of Participants With Disease-Free Survival (DFS) Events(Event driven (until data cutoff: 29 February 2012: up to 49 months))
- Time to Distant Disease-Free Survival (DDFS) Event(Event driven (until data cutoff: 29 February 2012: up to 49 months))