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

Study on Nanosomal Docetaxel for Triple Negative Breast Cancer Safety.

Recruiting
18-65 years
Female
Phase 3
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study investigates a new medicine, called Nanosomal Docetaxel Lipid Suspension (NDLS), for treating a specific type of breast cancer known as triple-negative breast cancer (TNBC). NDLS is a special form of docetaxel, a cancer-fighting drug, designed to be safer by removing some harmful ingredients found in older versions. This study compares different doses of NDLS to Taxotere®, another common cancer drug, in patients with advanced breast cancer. Participants will continue treatment unless their cancer worsens or they experience severe side effects. The study involves regular check-ups and scans to see how the cancer responds to the treatment. A total of 657 patients will take part, and they will be split into groups to test different doses of NDLS and Taxotere®.

  • The study lasts until the patient experiences unacceptable side effects or cancer progression.
  • Participants will need to visit the clinic for regular assessments and scans.
  • There may be risks of side effects, and patient safety will be closely monitored.
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Study details
    Triple Negative Breast Cancer

NCT03671044

Jina Pharmaceuticals Inc.

1 April 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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