“A prospective, randomized, multi-centric clinical study to compare Trastuzumab (Test Product, Zydus) with Trastuzumab (Reference Product, Roche/Genentech ) in patients with metastatic breast cancer.â€
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 102
- 试验地点
- 19
- 主要终点
- To compare the single dose truncated pharmacokinetics (Cmax, AUC0-168hrs) of Trastuzumab (Zydus) as
研究概览
简要总结
The purpose of this study is to determine the Pharmacokinetics, Safety, tolerability and efficacy of Trastuzumab (test, Zydus) as compared to Herceptin (Reference Product, Roche/Genentech), both in combination with Paclitaxel in patients with Metastatic Breast Cancer. The proposed subjects will be randomly assigned in a 2:1 ratio to Trastuzumab (Zydus - Test) and Trastuzumab (Reference). The computer generated randomization scheme will use blocks of 3 to maintain randomization balance. This study will be initiated only after obtaining the approvals of Institutional/ Independent Ethics Committee (IEC), clinical trial permission from the Drug Controller General of India (DCGI). The subjects qualifying inclusion and exclusion criteria will be invited to participate in this study. The recruitment will happen as per randomization schedule. Randomization list will be generated by computer generated randomization number. Randomization concealment will be achieved by the use of temper proof sealed opaque envelopes. The study will be an open label study. All the Response assessment for the enrolled patients will be based on RECIST Criteria Version 1.1. The study will be conducted in 5 patients to determine the infusion toxicities. These patients will be reviewed by the DSMB. If there are no clinically significant or higher incidences of infusion reactions, the participants will continue to receive the therapy and complete the 4 cycles as per the protocol. On completion of review of single cycle of infusion toxicity of 5 subjects, further randomization of the study will be initiated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients with histologically or cytologically confirmed uni-dimensionally measurable metastatic breast cancer.
- •Have a strong Her-2 over-expression as described by a 3+
- •Patients with ECOG performance status 0-2.
排除标准
- •Newly diagnosed metastatic breast cancer patients other than HER2 +ve patients.
- •(Note since there is no treatment other than Trastuzumab for HER2+ve MBC such patients will not be excluded)
- •Have a history of congestive heart failure (CHF)
- •Have an abnormal LVEF
- •History of myocardial infarction within 6 months before randomization.
- •Have severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
- •Have had prior mediastinal irradiation (except internal mammary-node irradiation for the present breast cancer).
- •Have a history of hypersensitivity to the Trastuzumab or to drugs with similar chemical structures, or to any of the excipients, or to murine proteins.
- •Have any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.
结局指标
主要结局
To compare the single dose truncated pharmacokinetics (Cmax, AUC0-168hrs) of Trastuzumab (Zydus) as
时间窗: Day 1, Cycle 1 - Before the study drug administration i.e. 0 minutes, end of study drug administration (i.e. after 1.5 hours (end of infusion) ±15 minutes, after 3 hours ±15 minutes, after 4.5 hours ±15 minutes and after 6 hours ±15 minutes) | Day 7 - (168 hours ± 24 hours) | Day 14 - Optional - (336 hours ± 24 hours) | Day 1, Cycle2 ± 2 days | Day 1, Cycle 3 ± 2 days | Day 1, Cycle 4 ± 2 days | Day 21 after cycle 4 ± 7 days
compared to Herceptin (Reference) upto Day 7, both in combination with Paclitaxel in patients with
时间窗: Day 1, Cycle 1 - Before the study drug administration i.e. 0 minutes, end of study drug administration (i.e. after 1.5 hours (end of infusion) ±15 minutes, after 3 hours ±15 minutes, after 4.5 hours ±15 minutes and after 6 hours ±15 minutes) | Day 7 - (168 hours ± 24 hours) | Day 14 - Optional - (336 hours ± 24 hours) | Day 1, Cycle2 ± 2 days | Day 1, Cycle 3 ± 2 days | Day 1, Cycle 4 ± 2 days | Day 21 after cycle 4 ± 7 days
Metastatic Breast Cancer.
时间窗: Day 1, Cycle 1 - Before the study drug administration i.e. 0 minutes, end of study drug administration (i.e. after 1.5 hours (end of infusion) ±15 minutes, after 3 hours ±15 minutes, after 4.5 hours ±15 minutes and after 6 hours ±15 minutes) | Day 7 - (168 hours ± 24 hours) | Day 14 - Optional - (336 hours ± 24 hours) | Day 1, Cycle2 ± 2 days | Day 1, Cycle 3 ± 2 days | Day 1, Cycle 4 ± 2 days | Day 21 after cycle 4 ± 7 days
次要结局
- To compare Objective Response Rate (ORR) – Sum of Complete response (CR) and partial response at end of study and to compare the pharmacokinetics (Cmax, AUC0-last) and immunogenicity(At the End of study (21 days after last dose). i.e.)