PER-027-18招募中未知
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
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 88
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 ≥ 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.
- •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.
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.
研究者
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