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.