CTRI/2018/07/014881
Completed
Phase 3
A Prospective, Randomized, Multicenter, Comparative, Openlabel,Parallel study to evaluate the Efficacy, Safety andPharmacokinetics of Test-Trastuzumab Emtansine (ZRC-3256;Cadila Healthcare Ltd) and Reference-TrastuzumabEmtansine(Kadcyla®, a product of Roche) inHER2- Positive Metastatic Breast Cancer Patients.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- HER2- positive, metastatic breast cancer
- Sponsor
- Cadila Healthcare Ltd
- Enrollment
- 168
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Female subjects of age 18 to 65 years (both inclusive).
- •2\.Subject with pathologically (histologically or cytologically) confirmed, uni\-dimensionally measurable invasive metastatic breast cancer.
- •3\.Subjects with a strong HER\-2 over\-expression as described by a 3\+ score by immunohistochemistry (IHC) or a positive fluorescence in\-situ hybridization (FISH).
- •4\.For the treatment of subjects with HER2\-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Subject should have either:
- •Received prior therapy for metastatic disease, or
- •Developed disease recurrence during or within six months of
- •completing adjuvant therapy.
- •5\.Subject with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\.
- •6\.Left ventricular ejection fraction (LVEF) \>\=50% by 2 D ECHO.
- •7\.Subjects with following laboratory results:
Exclusion Criteria
- •1\.Subject with history of Trastuzumab emtansine treatment.
- •2\.Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease).
- •3\.History of symptomatic chronic heart failure (New York Heart Association \[NYHA] Classes II\-IV) or serious cardiac arrhythmia requiring treatment.
- •4\.Current uncontrolled hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg), or unstable angina.
- •5\.Pregnancy or lactation.
- •6\.Current known active infection with HIV, hepatitis B virus, or hepatitis C virus.
- •7\.Have a history of hypersensitivity to the Trastuzumab emtansine or to drugs with similar chemical structures, or to any of the excipients, or to murine proteins.
- •8\.Have any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.
- •9\.Any chemotherapy, hormonal therapy, radiotherapy or surgery for the treatment of breast cancer within 3 weeks of screening.
- •10\.Have any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.
Outcomes
Primary Outcomes
Not specified
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