This trial aims to see if combining two medications, T-DM1 (Kadcycla) and palbociclib (Ibrance) is better than just using T-DM1 in treating HER2+ breast cancer that has spread. The main outcome that will be measured is survival without the cancer growing or spreading. The study is being conducted in Arizona, the United States.
There are a number of treatments for breast cancer. Cancer that is positive for HER2 can be specifically targeted. Both T-DM1 and palbociclib are targeted therapies used for the treatment of HER2+ breast cancer. It is not known if treating patients with T-DM1 and palbociclib is better than treating them with just palbociclib alone.
This trial aims to see if combining two medications, T-DM1 and palbociclib, is better than just using T-DM1 in treating HER2+ breast cancer that has spread. The main outcome that will be measured is how long the patients go without cancer growing or spreading.
Who are they looking for?
132 patients are being recruited. To be included in this trial, patients must have an adequate heart, kidney, and bone marrow function. Patients must agree to the treatment plan, trial visits and, other trial procedures.
Patients are not allowed in the trial if they have been treated with T-DM1 or other drugs like palbociclib before. Patients will be excluded if they have active brain cancer, allergies to the drugs in the study, infections, heart failure or heart issues, or if they are being treated with another anti-cancer drug.
How will it work
This trial will consist of two groups. One group will receive treatment with T-DM1 and palbociclib. The other group will only receive treatment with T-DM1. Patients will be followed up for up to 4 years and response to treatment, survival without cancer growing and overall survival will be evaluated.