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

Source: https://onco.cc/trials/nct03671044/  
OnCo record `nct03671044` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Docetaxel in triple-negative breast cancer, run by Jina Pharmaceuticals Inc., now recruiting.

## Summary

A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients is a phase 3 interventional study registered as NCT03671044 by Jina Pharmaceuticals Inc., with 657 participants planned, started 2018-07-10 and due to reach its primary completion in 2025-05-31. Interventions recorded: Nanosomal Docetaxel Lipid Suspension (75 mg/m2), Nanosomal Docetaxel Lipid Suspension (100 mg/m2) and Taxotere® (100 mg/m2).

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT03671044
- Phase: 3
- Setting: A Global, Multicenter, Three Arms, Open-label Randomized Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension Compared to Taxotere® (Docetaxel Injection Concentrate) in Triple-negative Breast Cancer Patients With Locally Advanced or Metastatic Breast Cancer After Failure to Prior Chemotherapy
- Sponsor: Jina Pharmaceuticals Inc.
- Enrolled: 657

## Sources

- ClinicalTrials.gov NCT03671044: https://clinicaltrials.gov/study/NCT03671044

## Connected records

- cancers: [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- drugs: [Docetaxel](https://onco.cc/drugs/docetaxel/)
- companies: [Intas Pharmaceuticals (Accord Healthcare)](https://onco.cc/companies/intas/)

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