This phase 3 trial aims to evaluate the effectiveness of palbociclib (Ibrance) in combination with standard treatments for HER2 positive breast cancer. The main outcome to be investigated is progression free survival. This trial is taking place in Alabama, Illinois, Iowa, Nebraska and Oklahoma in the United States.
Anti-HER2 therapy is a standard therapy for HER2 positive breast cancer. it works by interfering with the HER2 gene and helps to stop cancer growth. Endocrine therapy is also a standard therapy for breast cancer and it works by stopping or decreasing the production of hormones (such as estrogen) that help tumors grow.
Palbociclib is a CDK4/CDK6 inhibitor. It is a targeted therapy that works by targeting specific cancer cells and not normal cells of the body. It has been approved for treatment of ER positive breast cancer. It is thought that by using palbociclib with the standard treatments for HER2 disease the survival of metastatic breast cancer patients will be prolonged. The study will evaluate effectiveness by looking at the rates of progression free survival in patients.
Who are they looking for?
This study will recruit 496 patients who have invasive breast cancer that is metastatic or non-responsive to radiation or surgery. Normal blood test results are required to be eligible. Patients must agree to use a form of contraception for the duration of the study. Patients should have received chemotherapy prior to the study.
Patients who have received CDK inhibitors in the past will be excluded from this study. Those with any known allergic reactions to drugs like palbociclib are not eligible. Patients with heart conditions, diabetes, HIV, liver disease or hepatitis cannot take part.
How will it work
Patients will be randomly divided into two groups. One group will receive palbociclib daily, an anti-HER2 therapy (such as trastuzumab) every 3 weeks and an endocrine therapy (such as letrozole) until confirmed disease progression. The other will receive anti-HER2 therapy every 3 weeks and endocrine therapy until confirmed disease progression.
Progression-free survival (time from treatment until disease progression) will be measured for up to 24 months.