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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

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.
Study details
    Triple Negative Breast Cancer

NCT03671044

Jina Pharmaceuticals Inc.

1 April 2025

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Learn more about clinical trials

What is a clinical trial?

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

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

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

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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