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

Recruiting Phase 3 Interventional Study
Triple Negative Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 65
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
657 (estimated)
Sponsor
Jina Pharmaceuticals Inc. · Industry
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About This Trial
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 st…
Trial Locations
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Eligibility 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 ther…
Contacts

Mr. Prashant Modi

+917940202375

prashantmodi@lambda-cro.com

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