A Clinical Trial to evaluate the Efficacy and Safety of Intravenous Infusion of Nanosomal Paclitaxel Lipid Suspension and Taxol in Metastatic Breast cancer patients.

Phase 2

Completed

Conditions: Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Registration Number: CTRI/2010/091/001344

Lead Sponsor: Intas Pharmaceuticals Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

The patient is willing to give written, signed and dated, informed consent to participate in the study before initiating any study related procedures

Patient must have histopathologically /cytologically confirmed breast cancer

Patient must have metastatic breast cancer after failure of prior combination chemotherapy or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated

Patient with adequate bone marrow, renal and hepatic function

Exclusion Criteria

Patient who has a history of hypersensitivity reactions to drugs formulated with Cremophor EL.
Patient who was previously exposed to Taxane Injection
Patient who has taken more than 1 prior chemotherapy treatment/regimen for metastatic breast cancer

Study & Design

Study Type: BA/BE

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the Overall Response Rate (CR or PR) for evaluation of the efficacy of Nanosomal Paclitaxel Lipid Suspension (given as weekly or every-3-week regimen) and TaxolÂ® (given as every-3-week regimen) in patients with metastatic breast cancer after failure of prior chemotherapyTimepoint: 18 weeks

Secondary Outcome Measures

Name	Time	Method
To evaluate safety of the patients of each arm who are exposed to the investigational medicinal product 2.To compare the Disease Control Rate (CR or PR or SD) for evaluation of the efficacy of Nanosomal Paclitaxel Lipid Suspension (given as weekly or every-3-week regimen) and TaxolÂ® (given as every-3-week regimen) in patients with metastatic breast cancer after failure of prior chemotherapyTimepoint: 18 weeks for Disease Control Rate (CR or PR or SD) and at each visit for safety analysis