This phase 3 trial will investigate the effectiveness of 2 experimental drugs, DS-8201a vs T-DM1, for the treatment of breast cancer (BC). The main outcome will be survival without cancer worsening.
Breast cancer (BC) is a common and treatable form of cancer. Cancers, including BC, can be categorized depending on certain proteins. HER2 is a protein that is highly expressed on someBC tumors. Some drugs are designed to specifically target HER2-positive BCs. Trastuzumab (Herceptin®) is an antibody that blocks tumor growth. TZT has been prescribed for many years and has proven effective. Research is ongoing to improve its effectiveness. One way of doing so is attaching or ‘conjugating’ it to another chemical. These are called antibody-drug conjugates (ADCs). DS-8201aand T-DM1 (Kadcyla)are ADCs containing trastuzumab. The effectiveness of these drugs remains under investigation.
This trial will investigate the effectiveness of two experimental drugs, DS-8201a and T-DM1, for the treatment of BC. The main outcome will be survival without cancer worsening.
Who are they looking for?
This study will recruit 500 participants with HER2-positive BC. The BC must be spread to other organs or cannot be surgically removed. Participants must have adequate kidney and liver function. Women of childbearing age must use highly effective contraception during the trial and up to 7 months after the last drug dose.
Patients cannot take part in the trial if they have been treated with an anti-HER2 ADC. They cannot have uncontrolled heart disease, history of lung disease, or brain tumors.
How will it work
Patients will be randomly assigned to one of two groups. One group will receive DS-8201a. Theother group will receive T-DM1. Both drugs will be administered intravenously.
The main outcome will be survival without cancer worsening within 45 months.