This phase 2 study will investigate the effectiveness of experimental medication tucatinib and trastuzumab (Herceptin) to treat brain metastases in HER2-positive breast cancer (BC). The main outcome will be overall survival (OS). This trial is recruiting in Alabama and Texas, the US.
There are many different subtypes of breast cancer (BC). One subtype is HER2-positive(+) BC. These cancer cells express a protein called human epidermal growth factor. It is more aggressive than other BC subtypes. Some patients with advanced cancer can develop leptomeningeal disease (LMD). This leads to tumors in the membrane surrounding the brain and spinal cord. Trastuzumab is a standard treatment for HER2+ BC. It blocks HER2 receptors and slows tumor growth. Tucatinib is an experimental HER2-receptor blocker.
This study will investigate tucatinib and trastuzumab to treat LMD in HER2+ BC. The main outcome will be OS.
Who are they looking for?
This trial will recruit 30 patients with HER2+ BC and LMD. Previous treatments should have been completed at least 2 weeks before the start of the study and any side effects must have subsided. Participants must have adequate kidney, liver, heart, and bone marrow function.
Patients cannot take part in the study if they are pregnant or breastfeeding. Highly effective contraceptive methods should be used during the study and for 6 months after it ends. Patients with active infections, liver disease or heart dysfunction are excluded from the trial. Other exclusion criteria are allergies to study drugs, history of some cancers (in last 5 years), recent heart attack (within 6 months).
How will it work
All patients will be treated with tucatinib and trastuzumab. Patients will also receive a chemotherapy drug called capecitabine (Xeloda). Treatment will follow a 21-day cycle. Tucatinib will be taken orally every day (300 mg). Trastuzumab will be administered intravenously once every 3 weeks. Capecitabine will be taken orally every day for the first 14 days. Treatment will last up to 3 years.