Study Comparing Two Paclitaxel Treatments for Breast Cancer Patients Ages 18 to 75

What this Trial Is About

Researchers are evaluating the bioequivalence of two forms of paclitaxel protein-bound particles for injectable suspension albumin-bound in patients with breast cancer. This randomized, open-label, two-period crossover Phase 1 study aims to compare the test product with the reference product Abraxane400 mg doses to determine if they have similar effects on the body. The study focuses on breast cancer patients who have specific treatment histories and meet defined health criteria. Participants will receive a single intravenous infusion of either 260 mgm2 of the test paclitaxel protein-bound particles or 260 mgm2 of Abraxane400 mg in separate periods. The study involves random assignment to one of these treatments and later crossover to the other, allowing each participant to receive both treatments in a controlled sequence. The intervention groups are monitored without masking, meaning both researchers and participants know which treatment is administered. Throughout the study, participants will be closely monitored for up to 72 hours after dosing to measure peak plasma concentration Cmax, area under the plasma concentration versus time curve AUC0-t and AUC0-1, and other pharmacokinetic parameters such as time to peak concentration and elimination half-life. Adverse events will be tracked for up to 6 months. Participants will undergo blood tests and other health assessments to monitor safety and drug behavior. The total duration of involvement will depend on the timing of the crossover and follow-up periods.

Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) in Breast Cancer Patients