This study is testing a new version of a chemotherapy drug called docetaxel, named Nanosomal Docetaxel Lipid Suspension (NDLS), for women with triple negative breast cancer. NDLS aims to improve safety by removing certain ingredients found in the standard docetaxel drug, Taxotere®. Researchers want to see if NDLS is as effective and safe as Taxotere® in treating locally advanced or metastatic triple negative breast cancer. The study will compare two doses of NDLS (75 mg/m2 and 100 mg/m2) against Taxotere® (100 mg/m2). Success will be measured by how many patients respond to the treatment, such as their tumors shrinking or disappearing, over about two years. You may be eligible if you are a woman between 18 and 65 years old with triple negative breast cancer who has received some prior chemotherapy.

Study design

This is a randomized, open-label study involving 657 participants. Participants will be assigned to one of three treatment groups by chance.

What's involved

Patients will continue treatment as long as their disease does not worsen and side effects are manageable. All imaging studies will be reviewed by an independent facility.

Compensation

Not stated in the trial record.

Follow-up

The main measure of success will be evaluated approximately two years after the study begins.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.