Comparing Two Treatments for Women with Triple Negative Breast Cancer
NCT03671044 · RecruitingThis study looks at how well Nanosomal Docetaxel Lipid Suspension works compared to Taxotere in women with triple negative breast cancer. The goal is to find out if the new formulation is safer and more effective. Participants will receive one of the two treatments after their previous chemotherapy has not worked. The study will include 657 patients who will be monitored for their response to the treatments.
Locations and contact
This trial is running at 4 locations in 2 countries. All of them are currently recruiting.
United States3 locations · 3 recruiting
- Columbus Regional Research Institute, LLCColumbus, GeorgiaRecruiting
- Cox Medical CenterSpringfield, MissouriRecruiting
- Gabrail Cancer CenterCanton, OhioRecruiting
India1 location · 1 recruiting
- Kailash Cancer Hospital & Research CentreVadodara, GujaratRecruiting
Who can join
Women aged 18 to 65 can join if they have triple negative breast cancer and have had one prior chemotherapy treatment. They must be able to give consent and have at least one measurable tumor. Participants should be in good health overall and have recovered from any previous treatments. The study team will confirm eligibility for each patient.
What happens during the trial
Participants will be randomly placed into one of three groups. One group will receive Nanosomal Docetaxel Lipid Suspension at 75 mg/m2, another group at 100 mg/m2, and the last group will receive Taxotere at 100 mg/m2. Treatments will be given every three weeks until there is disease progression or unacceptable side effects. Everyone will be closely monitored for their response to the treatment.
The trial team
Jina Pharmaceuticals Inc. is the main sponsor of this trial. Other partners include Intas Pharmaceuticals and Lambda Therapeutic Research. The study chair is Dr. Ravi Alamchandani from Lambda Therapeutic Research.
Important dates
The study started on July 10, 2018, and is currently enrolling participants. It is expected to complete by December 31, 2025, with the last updates on March 21, 2025.
Additional information
This is a Phase 3 trial, meaning it aims to show how well the treatment works and its safety. The trial is FDA-regulated and hopes to include 657 participants.
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