The Nanosomal Docetaxel Lipid Suspension (NDLS) consists of uniformly sized micro particles of docetaxel suspended in a lipid based formulation. The advantage of such a Lipid Based formulation of Docetaxel is an improvement of the safety profile by eliminating excipients, polysorbate 80 and ethanol which are present in conventional Docetaxel formulations (Taxotere®). 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 Taxotere® at the dose of 100 mg/m2 in triple-negative breast cancer patients with Locally Advanced or Metastatic Breast Cancer. Patients will continue the treatment in the absence of disease progression and unacceptable toxicity. Disease status and tumor response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) guidelines. 657 patients (219 patients per arm) will be randomized in the study. The trial will be conducted as per the ICH GCP Guidelines E6 (R1), Schedule Y (Amended Version 2013), Declaration of Helsinki (Fortaleza, Brazil, October 2013), ICMR Guidelines for Biomedical Research on Human subjects and in accordance with other applicable guidelines.
The patient willing to give written signed and dated informed consent to participate in the study.
Patient must have histopathologically or cytologically confirmed triple negative breast cancer.
Patients may have received one prior chemotherapy regimen for adjuvant therapy and/or one chemotherapy treatment/regimen for firstline metastatic therapy
Patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.
Patient who has a history of hypersensitivity reactions to Docetaxel or any other component of formulation or to any drugs formulated with polysorbate 80.
Patients with a history of HER2 positive over expression and hormone receptor positive (ER or PR)
Patient who is already exposed to Docetaxel injection in metastatic setting.
Any of the cardiac conditions like Unstable angina, Myocardial infarction within the past six months, Severe uncontrolled ventricular arrhythmias, Clinically significant pericardial disease, Electrocardiographic evidence of acute ischemia, Patient with evidence of abnormal cardiac conduction (e.g., bundle branch block or heart block) except in whom the disease has been stable for the past six months, History of cardiac disease that met the NYHA Classification class 2 or greater
Parallel
Nanosomal Docetaxel Lipid Suspension (75 mg/m2)
DrugEach vial containing lyophilized Docetaxel lipid powder, equivalent to 20 mg or 80 mg of anhydrous Docetaxel.
Nanosomal Docetaxel Lipid Suspension (100 mg/m2)
DrugEach vial containing lyophilized Docetaxel lipid powder, equivalent to 20 mg or 80 mg of anhydrous Docetaxel.
Taxotere® (100 mg/m2)
DrugDocetaxel Injection Concentrate; 20 mg/0.5 mL
Proportion of the patients with Objective Response Rate (i.e., CR + PR) as the Best Overall Response Rate (i.e., CR + PR) in the test arm (NDLS) compared to reference arm (Taxotere)
Non-inferiority of NDLS (75 mg/m2, 100 mg/m2) compared to Taxotere (100 mg/m2)
Progression free survival (PFS)
PFS will be evaluated from the date of first dosing to the date of tumor progression (as per the RECIST 1.1 Criteria) or death (due to any cause) whichever occurred first
To evaluate the overall survival (OS) of the patients
OS will be evaluated from the date of first dosing to the date of tumor progression (as per the RECIST 1.1 Criteria) or death (due to any cause) whichever occurred first
Incidence of adverse events as assessed by clinical examination, and/or laboratory parameters
adverse events as assessed by CTCAE v4.0
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Jina Pharmaceuticals Inc.
Lead sponsor
Intas Pharmaceuticals, Ltd.
Collaborator
Lambda Therapeutic Research Ltd.
Collaborator
