CTRI/2019/01/017029已完成3 期
A randomized, double-blind, parallel group, Phase III trial to compare the efficacy, safety, and immunogenicity of TX05 with Herceptin�® in subjects with HER2 positive early breast cancer
Tanvex Biologics Corp0 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
- 已完成
- 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. Signed written informed consent.
- •2. Females ââ?°Â¥ 18 years of age.
- •3. Histologically confirmed HER2 overexpressing invasive primary operable Stage II/IIIa breast cancer by
- •American Joint Committee on Cancer 7th Edition staging criteria. Tumor tissue sample must be available
- •for central analysis.
- •4. Planned surgical resection of breast tumor (lumpectomy or mastectomy, and SN biopsy or ALND).
- •5. Planned neoadjuvant chemotherapy.
- •6. HER2 overexpression as assessed by:
- •- Gene amplification by fluorescent in-situ hybridization (FISH), chromogenic in-situ hybridization
- •(CISH), or dual in-situ hybridization (DISH) (as defined by the manufacturerââ?¬•s kit instruction); OR
- •- Overexpression by immunohistochemistry (IHC) categorized as IHC 3+; OR
- •- Overexpression by immunohistochemistry categorized as IHC2+ with FISH, CISH, or DISH
- •confirmation.
- •7. Ipsilateral, measurable tumor longest diameter > 2 cm.
- •8. Known estrogen receptor (ER) and progesterone receptor (PR) hormone status prior to randomization. If
- •ER/PR status is not available locally, testing may be performed by central laboratory during Screening.
- •9. ECOG performance status of 0 or 1.
- •10. Adequate bone marrow, hepatic, and renal functions as evidenced by the following:
- •- Absolute neutrophils count ââ?°Â¥ 1,500/Ã?¼L
- •- Hemoglobin ââ?°Â¥ 9 g/dL
- •- Platelet count ââ?°Â¥ 100,000/Ã?¼L
- •- Creatinine clearance ââ?°Â¥ 40 mL/min
- •- Total bilirubin ââ?°Â¤ 1.5 x upper limit of normal (ULN)
- •- Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and alanine
- •aminotransferase (serum glutamic pyruvic transaminase) ââ?°Â¤ 2.5 x ULN
- •- Alkaline phosphatase ââ?°Â¤ 5 x ULN
- •11. LVEF ââ?°Â¥ 50% or within the normal level of the institution, as assessed by echocardiography or MUGA scan.
- •12. Able to comply with the study protocol.
- •13. Female subjects of childbearing potential must have a negative serum pregnancy test within 1 week of first
- •administration of study drug and agree to use effective contraception (hormonal contraceptive, intrauterine
- •device, diaphragm with spermicide, or condom with spermicide) throughout the study period and for
- •6 months after last administration of study drug.
排除标准
- •1. Participation in any interventional clinical study or having taken any investigational therapy during the
- •2 month period immediately preceding administration of the first dose of study drug.
- •2. Bilateral breast cancer.
- •3. Inflammatory breast cancer.
- •4. Metastases.
- •5. Previous chemotherapy, biologic therapy, radiation, or surgery for any active malignancy, including breast
- •6. Subjects with one or more of the following conditions:
- •- Cardiac insufficiency (New York Heart Association III or IV); myocardial infarction,
- •coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident, unstable
- •angina pectoris, uncontrolled arrhythmia, or pulmonary embolus within the previous 12 months prior to
- •the first administration of study drug.
- •- Clinically significant active infection.
- •- Poorly controlled diabetes mellitus.
- •- Uncontrolled hypertension (blood pressure > 150/100 mmHg despite optimal medical therapy).
- •- Major surgery, significant traumatic injury, or radiation therapy within 4 weeks of first administration
- •of study drug.
- •- Grade 3 hemorrhage within 4 weeks of first administration of study drug.
- •7. Pre-existing clinically significant (ââ?°Â¥ Grade 2) peripheral neuropathy.
- •8. History of malignancy within the last 5 years, except adequately excised squamous or basal cell carcinoma
- •of the skin, cervical carcinoma in situ, and superficial bladder cancer.
- •9. Severe dyspnea at rest requiring supplementary oxygen therapy.
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