A Randomized, Open-label Study to Compare Progression-free Survival in Patients With HER2 Positive Metastatic Breast Cancer Who Continue or Discontinue Herceptin in Combination With 2nd Line Chemotherapy, Having Progressed on 1st Line Chemotherapy in Combination With Herceptin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 58
- 主要终点
- Progression-Free Survival (PFS) - Percentage of Participants With an Event
研究概览
简要总结
This 2 arm study will compare the efficacy and safety of continuation or discontinuation of Herceptin treatment in combination with 2nd line chemotherapy, in patients with HER2 positive metastatic breast cancer whose condition has progressed on 1st line chemotherapy plus Herceptin. Patients will be randomized either to continue or discontinue Herceptin treatment (2mg/kg iv infusion weekly, or 6mg/kg iv infusion every 3 weeks) while receiving 2nd line chemotherapy of the investigator's choice. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients, >=18 years of age;
- •metastatic breast cancer;
- •HER2 overexpression (IHC 3+ and/or FISH positive);
- •disease progression during or after previous 1st line chemotherapy plus Herceptin;
- •scheduled to receive 2nd line chemotherapy.
排除标准
- •incompatibility with previous Herceptin therapy;
- •pregnancy.
研究组 & 干预措施
Chemotherapy Alone
Chemotherapy, schedule and dose at the investigator's discretion.
干预措施: Chemotherapy (Drug)
Chemotherapy, Trastuzumab
Trastuzumab, at the investigator's discretion, either 2 milligrams per kilogram (mg/kg) intravenous (i.v.) every 7 days or 6 mg/kg i.v. every 3 weeks. Chemotherapy, schedule and dose at the investigator's discretion.
干预措施: trastuzumab (Drug)
Chemotherapy, Trastuzumab
Trastuzumab, at the investigator's discretion, either 2 milligrams per kilogram (mg/kg) intravenous (i.v.) every 7 days or 6 mg/kg i.v. every 3 weeks. Chemotherapy, schedule and dose at the investigator's discretion.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) - Percentage of Participants With an Event
时间窗: Baseline (BL) and every 8 weeks thereafter
PFS was defined as the time from randomization to the date of documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or the date of occurrence of a second primary cancer, or date of death from any cause, whichever comes first. Participants were censored at the last tumour evaluation.
Progression-Free Survival - Time to Event
时间窗: BL and every 8 weeks thereafter
The median time from randomization to PFS event. Participants were censored at the last tumour evaluation.
次要结局
- Overall Survival - Time to Event(BL and every 8 weeks thereafter)
- Percentage of Participants With a Best Overall Response of CR or PR(BL and every 8 weeks thereafter)
- Overall Survival (OS) - Percentage of Participants With an Event(BL and every 8 weeks thereafter)
- Percentage of Participants by Best Overall Response (BOR)(BL and every 8 weeks thereafter)