Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Nanosomal Docetaxel Lipid Suspension for Injection of of Intas Pharmaceuticals Limited, India: Dose: 75 mg/meter square
Mode of Administration:
Intravenous
Duration of
treatment: Patient will be dosed with drug until disease progression and/or unacceptable toxicity
Intervention2: Nanosomal Docetaxel Lipid Suspension for Injection of of Intas Pharmaceuti
Duration of treatment: Patient will be dosed with drug until disease progression and/or unacceptable toxicity
Control Intervention1: Taxotere (docetaxel) Injection Concentrate of Sanofi-Aventis Deutsc
Duration of treatment: Patient will be dosed with drug until disease progression and/or unacceptable toxicity
Sponsors
Intas Pharmaceuticals Limited
Jina Pharmaceuticals Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient willing to give written signed and dated informed consent to participate in the study. 2. Patient must have histopathologically or cytologically confirmed triple-negative breast cancer. 3. Patients may have received one prior chemotherapy regimen for adjuvant therapy and/or one chemotherapy treatment/regimen for first-line metastatic therapy 4. Patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. 5. Have at least one measurable lesion as per the RECIST criteria (version 1.1). 7. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 8. Left Ventricular Ejection fraction (LVEF) greater than or equal to 50 percentage as per Echocardiography (ECHO). 8. Patient must have recovered from any toxic effects of previous chemotherapy or radiotherapy as judged by the Investigator. 9. Previous chemotherapy or radiotherapy should be completed 4 weeks prior to start of IMP administration. 10. Patients with life expectancy of at least 6 months. 11. Serum pregnancy test at screening and urine pregnancy test on Day 1 (before randomization) must be negative. 12. Sexually active women, unless surgically sterile or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to Study drug administration] sexual partner) for at least 4 weeks prior to study drug administration, during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. 13. Patient with adequate bone marrow, renal and hepatic function.
Exclusion criteria
Exclusion criteria: 1. Patient who has a history of hypersensitivity reactions to Docetaxel or any other component of formulation or to any drugs formulated with polysorbate 80. 2. Patients with a history of HER2 positive over expression and hormone receptor positive (ER or PR) 3. Patient who is already exposed to Docetaxel injection in metastatic setting. 4. Any of the cardiac conditions like Unstable angina, Myocardial infarction within the past 6 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 5. Uncontrolled diabetes or infection. 6. Known history of drug addiction within last one year. 7. Patients with known CNS lesions (brain metastasis or carcinomatous meningitis) except for asymptomatic brain metastases. 8. The receipt of an investigational medicinal product or participation in other drug research study within a period of 30 days prior to the first dose of investigational medicinal Product for the current study. 9. Pre-existing motor or sensory neurotoxicity of a severity greater than or equal to grade 2 as defined by NCI CTCAE 4.03 criteria. 10. Known case of HIV infection. 11. 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. 12. Patients who are unwilling or unable to follow protocol requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the efficacy and non-inferiority of Test product in comparison with Reference drugTimepoint: Visit 1, 8, 14, 20, 25, 31, 37, 43, 49 | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the safety of the patientsTimepoint: Visit 1 to visit 49 | — |
Countries
India
Contacts
Public ContactMr Prashant Modi
Lambda Therapeutic Research Ltd
Outcome results
None listed