This trial is examining the effectiveness of the antibody-drug conjugate SYD985 for HER2-positive inoperable advanced breast cancer. The main outcome to be measured will be time from treatment until disease progression or the time taken for tumor growth or spread. This study is being conducted in Baltimore, Maryland, inthe United States.
There are several treatment options for HER2-positive advanced breast cancer. HER2-positive breast cancer is associated with the overexpression of human epidermal growth factor receptor 2. This can lead to cancer growth. Standard treatment for HER2-positive breast cancers are HER2 inhibitors (blockers). SYD985 is a new HER2 inhibitor under development.
The main outcome to be measured will be progression-free survival or the time taken for tumor growth or spread. The side-effects of the drug will also be measured.
Who are they looking for?
This study will recruit 345 participants whose cancer has progressed after at least 2 other HER2 inhibitors. Patients should have adequate organ function and blood counts.
Patients should not have active infections, brain metastases, gastrointestinal disorders, or cardiovascular disease.
How will it work
Participants will be randomly assigned to treatment with SYD985 or another treatment chosen by the doctor. SYD985 will be delivered by IV (into a vein) every 3 weeks. The safety and effectiveness of the drug will be monitored and side-effects such as diarrhea or low white blood cells will be noted.
Surivial, disease progression, treatment response, and quality of life will be monitored for up to 2 years.