Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Nanosomal Docetaxel Lipid Suspension for Injection: Patients will be administered Nanosomal Docetaxel Lipid Suspension (Test product) (75 mg/m2) as per randomization schedule, by IV inf
10 minute deviation will be allowed in this regard) in each cycle of 21 days. Each patient will receive 6 cycles of IMP
Control Intervention1: Taxotere®(Docetaxel)Injection Concentrate, 20 mg/mL: Pat
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: • Patient must have histopathologically /cytologically confirmed breast cancer • Patient must have locally advanced or metastatic breast cancer after failure of prior chemotherapy. • Have at least one measurable lesion as per the RECIST 1.1 criteria • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 • Left Ventricular Ejection fraction (LVEF) greater than or equal to 50% as per Echocardiography (ECHO). • Patient must have recovered from any toxic effects of previous chemotherapy or radiotherapy as judged by the Investigator. • No previous radiotherapy to more than 25% of marrow-containing bones. • Previous chemotherapy/radiotherapy should be completed 4 weeks prior to start of IP administration • Patients with life expectancy of at least 6 months
Exclusion criteria
Exclusion criteria: •Patient who has a history of hypersensitivity reactions to docetaxel or any other component of formulation or to other drugs formulated with polysorbate 80. •Patient who has already exposed to Docetaxel injection. •Patient in which hormone therapy is indicated as per investigatorâ??s discretion. •Patient who has taken more than 2 prior chemotherapy treatment/regimen •Any other condition that, in the investigatorâ??s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study •Patients with known CNS lesions(brain metastasis or carcinomatous meningitis) •Known history of drug addiction within last 1 year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the overall response rate (complete or partial responses) to evaluate the efficacy of Nanosomal Docetaxel Lipid Suspension versus Taxotere® in patients with locally advanced or metastatic breast cancer.Timepoint: NIL | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of the patients who are exposed to the investigational medicinal products. To compare the Disease Control Rate (CR+PR+SD) to evaluate the efficacy of Nanosomal Docetaxel Lipid Suspension versus Taxotere® in patients with locally advanced or metastatic breast cancer. Timepoint: NIL | — |
Countries
India
Contacts
Public ContactMr Rajesh CN
Lambda Therapeutic Research Ltd
Outcome results
None listed