CTRI/2023/05/052997进行中（未招募）3 期
A Prospective, Randomized, Multicenter, Comparative, Double-blind, Parallel study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Biosimilar Pertuzumab (ENZENE) with Reference Pertuzumab (Perjeta®, Genentech Inc.,) in Previously Untreated Patients with HER2 Positive Metastatic Breast Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
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 18 to 65 years of age (both inclusive).
- •2. Patient with pathologically (histologically or cytologically) confirmed breast cancer with
- •stage IV i.e. Metastatic disease, atleast M1 as per AJCC TNM classification
- •3. With at least one measurable metastatic target lesion (based on RECIST criteria,
- •version1.1).
- •4. Documentation of HER2 gene amplification by fluorescent in situ hybridization (FISH); as
- •defined by a ratio >2.0) OR documentation of HER2-overexpression by
- •immunohistochemistry (IHC) (defined as IHC3+, or IHC2+ with FISH confirmation)
- •5. Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 2.
- •6. Left ventricular ejection fraction (LVEF) of = 50% at screening visit
- •7. Has life expectancy of at least 6 months from screening
- •8. Patient willing to provide written informed consent.
排除标准
- •1. History of severe hypersensitivity reaction to Pertuzumab, Trastuzumab or Docetaxel 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 prior single hormonal therapy)
- •3. History of systemic breast cancer treatment in the neo-adjuvant or adjuvant setting with a
- •disease-free interval from completion of the systemic treatment (excluding hormonal
- •therapy) to metastatic diagnosis of <12 months
- •4. History of approved or investigative tyrosine kinase/HER inhibitors for breast cancer in any
- •treatment setting, except trastuzumab used in the neoadjuvant or adjuvant setting.
- •5. 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.
- •6. Has active and uncontrolled metastasis to central nervous system
- •7. Has bone metastasis as the only measurable tumor
- •8. Has Preexisting Grade 3 or higher sensory or motor peripheral neuropathy at
- •randomization.
- •9. Has history of congestive heart failure of any New York Heart Association (NYHA) class,
- •serious cardiac arrhythmia requiring treatment, unstable angina pectoris, and/or myocardial
- •infarction within 6 months prior to screening
- •10. Has uncontrolled hypertension at screening (i.e. SBP = 140 mmHg and/or DBP = 90mmHg)
- •11. Has severe dyspnea at rest or requiring supplementary oxygen therapy
- •12. Has undergone any prior mediastinal irradiation (except internal mammary node
- •irradiation) for the present breast cancer
- •13. Patient’s having the following laboratory results at screening
- •a. Absolute neutrophil count (ANC) < 1,500/mm3
- •b. Hemoglobin (Hb) < 9 g/dL
- •c. Total Leucocyte count < 3000/mm3
- •d. Platelet count < 100,000/mm3
- •e. Total bilirubin level >1.5 times the upper limit of the normal laboratory range
- •(ULN)( > 2.5 times ULN in patients with liver metastases)
- •f. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels > 3.0
- •x upper limit of normal (ULN) ( >5 x ULN in patients with liver metastases)
- •g. Alkaline phosphatase > 2.5 x ULN ( > 5.0 x ULN if liver or bone metastases are present)
- •h. Serum Creatinine level > 1.5 times ULN
- •14. Patients suffering from acute or chronic infection(s)
- •15. Positive serology for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and
- •hepatitis C virus (HCV) at screening
- •16. Female patients of childbearing potential not willing to implement adequate non-hormonal
- •contraceptive measures during the study period
- •17. Patients who are pregnant or nursing
- •18. Major surgical procedure or significant traumatic injury within 28 days prior to study
- •treatment start or anticipation of the need for major surgery during the course of study
- •19. Has any concurrent disease or condition, which in the opinion of the investigator does not
- •allow participation of the patient in this study
- •20. Has partici
研究者
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