CTRI/2017/02/007892招募中3 期
A Prospective, Multicenter, Randomized, Double-blind, Parallel-group Study to Compare the Efficacy and Safety of GBR 200 (similar biologic of Trastuzumab) versus Innovator Trastuzumab both when given in combination with Paclitaxel in patients diagnosed with HER2 Positive Metastatic Breast Cancer
Glenmark Pharmaceuticals Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Female patients aged 18 years to 65 years of age (both inclusive) at the time of signing the ICF
- •2.Histologically confirmed diagnosis of breast cancer
- •3.Presence of metastatic disease as per Tumor Node Metastasis staging at screening
- •4.Has at least 1 measurable target lesion (tumor/lymph node) as per RECIST version 1.1 at screening
- •5.HER2 overexpression confirmed by immunohistochemistry (IHC) (IHC3+ or IHC2+ with positive fluorescent in situ hybridization [FISH] test result) at screening
- •6.Eastern cooperative oncology group (ECOG) status 0 to 2 at screening
排除标准
- •1.History of known severe hypersensitivity reaction to Trastuzumab or Paclitaxel or any of its excipients
- •2.Prior systemic therapy for metastatic disease, including cytotoxic chemotherapy, or previous anticancer therapy with signal transduction inhibitors (e.g. Lapatinib), biological drugs (e.g. Trastuzumab and Bevacizumab), experimental drugs (not approved for breast cancer therapy, anticancer drugs (except hormonal therapy)
- •3.Prior Trastuzumab or Taxane for adjuvant/neoadjuvant therapy for breast cancer within 12 months prior to randomization
- •4.Has received cumulative doses of anthracycline, exceeding 360 mg/m2 of BSA for doxorubicin, 720 mg/m2 of BSA for epirubicin, 120 mg/m2 of BSA for mitoxantrone, and 90 mg/m2 of BSA for idarubicin.
- •5.Has metastasis to central nervous system
- •6.Has undergone any prior mediastinal irradiation (except internal mammary node irradiation) for the present breast cancer
- •7.Has undergone surgery or radiation therapy within 4 weeks prior to randomization
- •8.Positive serology for Human Immunodeficiency Virus (HIV), Hepatitis B virus (HBV) and Hepatitis C virus (HCV) at screening
- •9.Patients who are pregnant or nursing
研究者
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