EUCTR2017-004190-13-HU进行中（未招募）1 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 Corp.0 个研究点目标入组 800 人开始时间: 2018年2月7日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Signed written informed consent.
- •2. Females = 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 manufacturer’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.
- •Central review will be performed retrospectively for subjects who were determined to be HER2 positive by use of either an approved assay listed in Appendix 1 or two different analytical test methods that were not
- •considered Sponsor approved. The results from non-approved IHC and in-situ hybridization analytical tests must be unequivocal (i.e., IHC result must be categorized as IHC3+).
- •If a subject’s tumor HER2 status cannot be determined by using an approved assay (see Appendix 1) or two different HER2 assays performed locally, a tissue sample can be sent to the central laboratory early in Screening for evaluation; results of the assessment will be returned to the investigator for inclusion in subjects’ source documents.
- •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 = 1,500/µL
- •- Hemoglobin = 9 g/dL
- •- Platelet count = 100,000/µL
- •- Creatinine clearance = 40 mL/min
- •- Total bilirubin = 1.5 x upper limit of normal (ULN)
- •- Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and alanine aminotransferase (serum glutamic pyruvic transaminase) = 2.5 x ULN
- •- Alkaline phosphatase = 5 x ULN
- •11. LVEF = 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
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 cancer.
- •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 (= 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.
- •10. Known positive status for human immunodeficiency virus.
- •11. Known acute or chronic-active infection with hepatitis B surface antigen or hepatitis C virus.
- •12. History or presence of a medical condition or disease that in the investigator's opinion would place the subject at an unacceptable risk for study participation.
- •13. Lactating or pregnant female.
- •14. Women of childbearing potential who do not consent to use highly effective methods of birth control (e.g. true abstinence [periodic abstinence {e.g. calendar ovulation, symptothermal, post-ovulation methods} and withdrawal are not acceptable methods of contraception], sterilization, or other non-hormonal forms of contraception) during treatment and for at least 6 months after the last administration of study drug. Subjects must agree to not breast-feed while receiving study drug.
- •15. Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products, trastuzumab, murine proteins, or to any of the excipients.
- •16. Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range despite optimal medical therapy.
- •17. Subject likely to not be available to complete all protocol required study visits or procedures.
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