Health Condition 1: null- Locally recurrent or metastatic breast cancer for which taxane-based therapy is a rational treatment option Health Condition 2: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Paclitaxel Injection Concentrate for Nano-dispersion (PICN): PICN will be infused i.v. over 30-minutes. The treatment period consist of 3-week treatment cycles (2 cycles)
Control Interv
Sponsors
Sun Pharma Advanced Research Company Ltd
Eligibility
Inclusion criteria
Inclusion criteria: -The subject has given written informed consent. -Histologically or cytologically confirmed diagnosis of breast cancer; -Locally recurrent or metastatic breast cancer; Age 18 to 65 years, inclusive; -ECOG Performance Status less than or eual to 1;
Exclusion criteria
Exclusion criteria: -Known hypersensitivity to both the study drugs or their excipients; -Presence of clinically symptomatic active CNS metastases; -Pre-existing clinically significant peripheral neuropathy; -Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) profiles of PICN and AbraxaneTimepoint: Pharmacokinetic (PK) samples will be collected on Day 1 & 2 of Cycle 1 & 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of PICN and AbraxaneTimepoint: Safety information will be collected during subject visits on Day 1, 8, 15 of Cycle 1 & 2 and end-of-study. | — |
Countries
India
Contacts
Public ContactDr Mudgal Kothekar MD
Sun Pharma Advanced Reserach Company Ltd.
Outcome results
None listed