A Multicenter Phase II Trial of Trastuzumab (Herceptin) Continuation in Combination With 2nd-line Chemotherapies After Progression on a 1st-line Chemotherapy Combined With Trastuzumab in Patients With HER2 Positive Metastatic Breast Cancer (Treatment Beyond Progression, TBP)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 114
- 主要终点
- Median Time to Disease Progression
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 (6mg/kg iv infusion every 3 weeks) while receiving second-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 + Herceptin;
- •scheduled to receive 2nd line chemotherapy.
排除标准
- •concurrent immunotherapy or hormonal therapy;
- •anthracyclines as part of previous 1st line chemotherapy or planned 2nd line chemotherapy;
- •cardiac toxicity during previous 1st line chemotherapy + Herceptin;
- •history of other malignancy within last 5 years.
研究组 & 干预措施
Trastuzumab + 2nd Line Chemotherapy
干预措施: Second line chemotherapy (Drug)
Trastuzumab + 2nd Line Chemotherapy
干预措施: trastuzumab [Herceptin] (Drug)
Only Chemotherapy
干预措施: Second line chemotherapy (Drug)
结局指标
主要结局
Median Time to Disease Progression
时间窗: Up to 5 years
Time to disease progression (TTP) in days was defined as the time from enrollment to objective disease progression (all categories other than objective disease progression was set to be censored including death before progression). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions. Tumor assessments were performed using computer tomography or magnetic resonance imaging. TTP as assessed by investigator, along with a recalculation done by computer algorithm is presented below. Median time was not assessed for 'Only Chemotherapy' group as randomization of participants was not feasible considering Trastuzumab widespread use in routine clinical practice.
次要结局
- Objective Response Rate(Up to 5 years)
- Biochemistry Safety Laboratory Parameters: Mean Urea, Sodium and Potassium Levels(Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study assessments (Up to 5 years))
- Hematology Safety Laboratory Parameters: Mean Hemoglobin Levels(Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years))
- Hematology Safety Laboratory Parameters: Mean Total Leukocytes Counts(Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years))
- Hematology Safety Laboratory Parameters: Percent of Differential for Neutrophils, Basophils, Eosinophils, Lymphocytes and Monocytes Counts(Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years))
- Clinical Benefit Rate(Up to 5 years)
- Overall Survival(Up to 5 years)
- Median Time to Treatment Failure(Up to 5 years)
- Number of Participants With Any Adverse Events and Serious Adverse Events(Up to 5 years)
- Biochemistry Safety Laboratory Parameters: Mean Serum Glutamic Oxaloacetic Transaminase, Serum Glutamic-pyruvic Transaminase and Alkali Phosphatase Levels(Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study Assessments (Up to 5 years))
- Biochemistry Safety Laboratory Parameters: Mean Total Bilirubin and Serum Creatinine Levels(Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study Assessments (Up to 5 years))
- Biochemistry Safety Laboratory Parameters: Mean Albumin Levels(Visit 1 [Screening Period (6 weeks prior to enrollment)] and Final study assessments (Up to 5 years))
- Hematology Safety Laboratory Parameter: Mean Platelets Counts(Visit 1 [Screening Period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years))
- Mean Left Ventricular Ejection Fraction(Visit 0 [Screening period (6 weeks prior to enrollment)] and final study assessments (Up to 5 years).)