Health Condition 1: null- HER2- positive, metastatic breast cancer
Conditions
Interventions
Intervention1: Trastuzumab emtansine (ZRC-3256, Cadila Healthcare
Ltd): Dosage: 3.6 mg/kg given as an intravenous infusion every 3 weeks (21 days cycle)
Duration of Treatment: 8 Cycles
Control Interve
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion 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: • Absolute neutrophil count >1500 cells/mm3 • Platelet count >100,000 cells/mm3 • Hemoglobin >=9.0 g/Dl • Total bilirubin • AST, ALT and alkaline phosphatase 8.Subjects must have recovered from all treatment related toxicities prior to randomization. 9.Pregnancy-related inclusions, including: •Subjects with negative serum pregnancy test at trial start •Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and till the end of study visit. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. 10.Ability to comply with study and follow â?? up procedures and provide written informed consent. 11.Patient with life expectancy of minimum of 7 months at screening.
Exclusion criteria
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. 11.Have any other medical or psychiatric condition that could compromise study participation. 12.Current clinical or radiographic evidence of Central nervous metastates.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the overall response rate (ORR) following administration of ZRC-3256 (Cadila Healthcare Limited) and Kadcyla® in patients with metastatic breast cancer based on Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1) achieved at end of 24 weeks.Timepoint: Timeframe: Week 0 (baseline), week 24 (visit 15) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the pharmacokinetic parameters (Cmax, AUC0-t ) 2. To compare the incidence and titres of Anti-Drug Antibodies at the end of 12 weeks (visit 11) and 24 weeks treatment (visit 15) 3. Comparative safety for treatment emergent adverse events by monitoring of significant clinical signs and symptoms and laboratory abnormalitiesTimepoint: 1)Cycle 1 2)Week 0 (baseline), week 12 and week 24 (visit 15) 3)Throughout the study. | — |
Countries
India
Contacts
Public ContactDr Manjunath K
Cadila Healthcare Ltd
Outcome results
None listed