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

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-

Trial Details

NCT ID
NCT03671044
Phase
PHASE3
Sponsor
Jina Pharmaceuticals Inc.
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Nanosomal Docetaxel Lipid Suspension (75 mg/m2)
  • Nanosomal Docetaxel Lipid Suspension (100 mg/m2)
  • Taxotere® (100 mg/m2)
Locations (sample)
  • Columbus, Georgia, United States|32.46098,-84.98771
  • Springfield, Missouri, United States|37.21533,-93.29824
  • Canton, Ohio, United States|40.79895,-81.37845
  • Vadodara, Gujarat, India|22.29941,73.20812

Key Eligibility Criteria

  • 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 t…
  • Patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.

For full eligibility, visit ClinicalTrials.gov.

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