A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients

Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semi synthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. It acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions. The Nanosomal Docetaxel Lipid Suspension (NDLS) consists of uniformly sized micro particles of docetaxel suspended in a lipid based formulation. Docetaxel Lipid Suspension for Injection 20 mg/80 mg was approved for marketing in India. Intas Pharmaceuticals Ltd., is marketing this drug in India under the Brand name of DOCEAQUALIP 20/80 (Nanosomal Docetaxel Lipid Suspension for Injection 20/80 mg/vial) since 2013. This randomized, open label study is designed to assess the efficacy and safety of Nanosomal Docetaxel Lipid Suspension at the dose of 75 mg/m2 and at the dose of 100 mg/m2 compared to reference product, Taxotere® at a dose of 100 mg/m2 in triple-negative breast cancer patients with Locally Advanced or Metastatic Breast Cancer. 657 patients (219 patients per arm) will be randomized in the study. To ensure consistent interpretation of measurable disease and objective endpoints for the study, all imaging studies performed throughout the study will be sent to an independent Central Radiological Facility for tumor measurement and evaluation of response. This independent review will have no impact on patient care. Continued participation in the study will be determined by assessment of clinical and radiological response by the Principal Investigator, and/or Radiologist. Efficacy evaluation will be done by CT scan/MRI and Bone scan at the end of treatment cycle 3 and will continue at every 3 cycles while the patient remains on treatment and compared to base line. Patient will continue study treatment until unacceptable toxicity or progression of disease. Patient will be screened up to 14 days prior to dosing and will be dosed on day 1. Patient will be advised to come in the facility at least 02 hours prior to dosing and will remain in the clinical facility until the completion of study drug administration. Dosing of patients will be done on ambulatory basis; hence patient hospitalization is optional. It is the responsibility of the PI to ensure that adequate medical supervision and care is available for the study patients during housing and entire duration of the study for utmost safety and wellbeing of the study patients. All safety analyses will be performed on the Safety set. Safety variables include AEs, clinical laboratory parameters, vital signs, physical examinations and electrocardiogram etc. Safety variables will be listed and summarized with descriptive statistics, as appropriate.