Comparing GQ1005 and T-DM1 Treatments in Adults with HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated with Trastuzumab and Taxane

What this Trial Is About

Researchers are comparing the effects and safety of two drugs, GQ1005 and Trastuzumab Emtansine T-DM1, in adults with HER2-positive breast cancer that cannot be removed by surgery or has spread to other parts of the body. This phase III trial focuses on patients who have previously been treated with trastuzumab and taxane. The study aims to understand which treatment might better manage this advanced form of breast cancer. Participants will be randomly assigned to receive either GQ1005 or T-DM1. Both drugs are given through intravenous infusions every 21 days. About 228 patients will take part, and the treatments will continue to be monitored over approximately 24 months to assess their impact on cancer progression and safety. During the study, participants will have regular assessments including scans to measure tumor size and blood tests to monitor the drugs in their system. Researchers will track how long patients live without cancer progression, overall survival, response rates, adverse events, and quality of life changes. These evaluations will help understand the benefits and risks of each treatment over time.

A Trial Comparing GQ1005 and T-DM1 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer