This trial aims to find out how well a new drug (DS-8201a) works on breast cancer that expresses low levels of the HER2 receptor and is not able to be operated on. The main outcome that will be measured is survival without cancer growing or spreading.
The drug DS-8201a is a new anti-cancer drug that works against breast cancer that expresses the HER2 receptor. It is a combination of an anti-cancer drug and a drug that targets the immune system. By doing this, the drug activates the immune system to kill the cancer cells. It is not known how well this will work in patients where the tumor expresses HER2 but to a low level.
This trial aims to find out how DS-8201a works on breast cancer that expresses low levels of the HER2 receptor and is not able to be operated on. The main outcome that will be measured is how long the patients go without cancer growing or spreading.
Who are they looking for?
540 patients will be recruited. Patients must have low HER2 expression on cancer cells. They must have cancer that cannot be operated on, or that has spread. Patients must have adequate heart, kidney, liver and bone marrow function.
Patients will be excluded from the trial if they have high HER2 expression, or have previously been treated with anti-HER2 therapy. Patients cannot be in the trial if they have another illness like an infection, lung disease, or heart problems.
How will it work
This trial will consist of two groups. One group will be treated with the trial drug, DS-8201a. The other group will be treated with any other type of approved medication that the doctor chooses. After treatment completes, the patients will be followed to see how they respond up to 3 years.