A Prospective, Randomized, Multicenter, Comparative, Double-blind, Parallel study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Test Pertuzumab (ZRC-3277, Cadila Healthcare Ltd.,) with Reference Pertuzumab (Perjeta®, Genentech Inc.,) in Previously Untreated Patients with HER2 Positive Metastatic Breast Cancer.

Zydus Research Centre Cadila Healthcare Limited0 个研究点目标入组 268 人开始时间: 待定最近更新: 2023年11月13日

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 268

研究概览入排标准研究者记录与标识符相似试验

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, adenocarcinoma metastatic breast cancer and
•candidate for chemotherapy. Note: Patients with de-novo Stage IV disease are eligible.
•3.With at least one measurable metastatic target lesion (based on RECIST criteria, version1.1).
•4.Documentation of following prior to randomization:
•a)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)
•(estrogen receptor/progesterone receptor positive subjects may be enrolled if they are HER2 positive) prior to
•randomization, see Section 6.4 for detailed criteria)
•5. Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1.
•6. Left ventricular ejection fraction (LVEF) of = 50% at baseline (within 42 days of randomization) as measured by
•echocardiography (ECHO) or multiple gated acquisition (MUGA).
•Note: ECHO is the preferred method. If the patient is randomized, the same method of LVEF assessment (i.e., ECHO or MUGA)
•must be used throughout the study and it should preferably be obtained at the same institution and preferably by the
•same assessor)
•7. Patient able to understand and willing to give the informed consent and able to comply with the requirements of the study
•8. A woman of childbearing potential must have a negative highly sensitive serum (ß-human chorionic gonadotropin [ß-hCG]) at
•screening and urine ß-hCG test at randomization.
•9. Woman of child-bearing potential must agree to use adequate contraceptive methods that is highly effective (with a failure
•rate of <1% per year), with low user dependency when used consistently and correctly, during the intervention period and for
•at least 7 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose
•of reproduction during the study and for a period of 7 months. The investigator should evaluate the effectiveness of the
•contraceptive method in relationship to the first dose of study intervention.

排除标准

•1. History of anticancer therapy for MBC, with the exception of single prior hormonal regimen for MBC,
•which must be stopped prior to randomization.
•Note 1: Anticancer therapy for MBC includes any epidermal growth factor receptor or anti- HER2 agents or
•vaccines, cytotoxic chemotherapy, or more than one prior hormonal regimen for MBC
•Note 2: Single prior hormonal regimen for MBC may include more than one hormonal therapy.If a patient is
•switched to a different hormonal therapy because of disease progression, this will be counted as two
•regimens, and the patient will not be eligible for the study. If a patient is switched to a different
•hormonal therapy for reasons other than disease progression (e.g., toxicity or local standard practice), this
•will be counted as single regimen.
•2. 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 <
•3. 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.
•4. Patients with CNS metastases, except for treated asymptomatic CNS metastases, provided all of the following
•criteria are met:
•a. Only supra-tentorial metastases allowed (i.e., no metastases to midbrain, pons, medulla, or spinal cord)
•b. No evidence of interim progression or hemorrhage after completion of CNS-directed therapy
•c. No ongoing requirement for corticosteroids as therapy for CNS disease (anticonvulsants at a stable dose are
•d. No stereotactic radiation within 14 days or whole-brain radiation within 28 days prior to randomization
•e. Leptomeningeal disease (i.e. carcinomatous meningitis)
•5. History of persistent Grade = 2 hematologic toxicity resulting from previous neoadjuvant or adjuvant therapy
•(all grades based on National Cancer Institute Common Toxicity Criteria for Adverse Events, Version 5.0 [NCI
•CTCAE v 5.0]).
•6. Current peripheral neuropathy of NCI-CTCAE, Version 5.0, Grade = 3 at randomization.
•7. Have a history of congestive heart failure (CHF) of any New York Heart Association (NYHA) criterion, or
•serious cardiac arrhythmia requiring treatment (except for atrial fibrillation,paroxysmal supraventricular
•tachycardia).
•8. History of myocardial infarction within 6 months before randomization.
•9. Current uncontrolled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100
•mmHg), or unstable angina.
•10. Current dyspnea at rest due to complications of advanced malignancy or other diseases that require
•continuous oxygen therapy.
•11. History of other malignancy within the previous 5 years, except for carcinoma in situ of the cervix or non-
•melanoma skin carcinoma that has been previously treated with curative intent.
•12. History of exposure to the following cumulative doses of anthracyclines:
•a. doxorubicin or liposomal doxorubicin > 360 mg/m2
•b. epirubicin > 720 mg/m2

研究者

发起方

Zydus Research Centre Cadila Healthcare Limited

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