A Phase IV Multi-Centric, Post-Marketing Study Evaluating the Safety, Immunogenicity and Efficacy of the Marketed Formulation of Hetero-Trastuzumab in Female Patients with HER2+ Breast Cancer.
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 20
- 主要终点
- 1.Significant clinical signs and symptoms developed during the treatment period.
研究概览
简要总结
It is a Phase IV Multi-Centric, Post-Marketing Study Evaluating the Safety, Immunogenicity and Efficacy of the Marketed Formulation of Hetero-Trastuzumab in Female Patients with HER2+ Breast Cancer. Hetero-Trastuzumab is available in 150 mg or 440 mg vials. Reconstitution with appropriate diluent (SWFI), yields a solution containing 21 mg/mL trastuzumab, at a pH of approximately 6. Safety is the primary objective, immunogenicity and efficacy are the secondary objectives of the study. Significant clinical signs and symptoms developed, changes observed in laboratory parameters, and Incidence of AEs leading to dose discontinuation of the medication are the part of primary outcome. Assessment of Anti-Trastuzumab antibodies, Objective of Response Rate (ORR), Progression Free Survival (PFS) after 6 months and 12 months of treatment, are the secondary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients of age 18 and above
- •Patients willing to give written, signed, and dated informed consent to participate in the study
- •Patients with breast cancer with evidence of HER2-overexpression by immunohistochemistry (IHC) or HER2 gene amplification by fluorescence in situ hybridization (FISH) or positive chromogenic in-situ hybridization (CISH) result.
- •Patients with any other approved indication(s) as per the prescribing information at the discretion of principal investigator.
排除标准
- •Patients with history of hypersensitivity to the trastuzumab or to any of the excipients, or to murine proteins or any other chemotherapeutic agent planned along with Trastuzumab
- •Male patients with breast cancer
- •Patients treated with Trastuzumab as (neo)adjuvant within 12 months or for metastatic breast cancer (Hetero-Trastuzumab use for MBC is allowed)
- •Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest
- •Patients with a history or evidence of cardiovascular diseases including congestive heart failure (CHF) of Grade IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia, unstable angina pectoris, myocardial infarction
- •Patients who are pregnant or a nursing mother.
- •Patients received treatment with investigational drug in the last 90 days.
结局指标
主要结局
1.Significant clinical signs and symptoms developed during the treatment period.
时间窗: 52 weeks
2. Significant changes observed in laboratory parameters during treatment period.
时间窗: 52 weeks
次要结局
- 1. Anti-Trastuzumab antibodies (ATA) against Hetero– Trastuzumab.(2. Objective Response Rate or progression, whichever is earlier.)
研究者
Dr Subhadeep Sinha MD
Hetero Labs Limited