Health Condition 1: null- Patients with metastatic breast cancer
Conditions
Interventions
Intervention1: Trastuzumab (Zydus): Trastuzumab will be administered in combination
with paclitaxel, at an initial dose of 8 mg/kg as a
90 minute intravenous infusion followed by
subsequent once every
Sponsors
Cadila Healthcare limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with histologically or cytologically confirmed uni-dimensionally measurable metastatic breast cancer. 2. Have a strong Her-2 over-expression as described by a 3+ 3. Patients with ECOG performance status 0-2.
Exclusion criteria
Exclusion criteria: 1. Newly diagnosed metastatic breast cancer patients other than HER2 +ve patients. (Note since there is no treatment other than Trastuzumab for HER2+ve MBC such patients will not be excluded) 2. Have a history of congestive heart failure (CHF) 3. Have an abnormal LVEF 4. History of myocardial infarction within 6 months before randomization. 5. Have severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy. 6. Have had prior mediastinal irradiation (except internal mammary-node irradiation for the present breast cancer). 7. Have a history of hypersensitivity to the Trastuzumab 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 patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the single dose truncated pharmacokinetics (Cmax, AUC0-168hrs) of Trastuzumab (Zydus) as compared to Herceptin (Reference) upto Day 7, both in combination with Paclitaxel in patients with Metastatic Breast Cancer.Timepoint: Day 1, Cycle 1 - Before the study drug administration i.e. 0 minutes, end of study drug administration (i.e. after 1.5 hours (end of infusion) ±15 minutes, after 3 hours ±15 minutes, after 4.5 hours ±15 minutes and after 6 hours ±15 minutes) Day 7 - (168 hours ± 24 hours) Day 14 - Optional - (336 hours ± 24 hours) Day 1, Cycle2 ± 2 days Day 1, Cycle 3 ± 2 days Day 1, Cycle 4 ± 2 days Day 21 after cycle 4 ± 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare Objective Response Rate (ORR) â?? Sum of Complete response (CR) and partial response at end of study and to compare the pharmacokinetics (Cmax, AUC0-last) and immunogenicityTimepoint: At the End of study (21 days after last dose). i.e. After 3 months. | — |
Countries
India
Contacts
Public ContactDr Chirag Shah
Cliantha Research Limited
Outcome results
None listed