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A Study of Tucatinib and Trastuzumab in Patients with HER2-Positive Locally Advanced Rectal Cancer

Trial Status: active

This phase II trial tests how well tucatinib and trastuzumab with standard chemotherapy works in treating patients with HER2-positive, KRAS wild-type rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced). HER2 (human epidermal growth factor 2) protein is involved in normal cell growth. HER2 may be made in larger than normal amounts by some types of cancer cells such as rectal cancer which would be referred to as HER2 positive. KRAS gene makes a protein that is involved in cell signaling pathways that control cell growth, cell maturation, and cell death. The natural, unchanged (unmutated) form of the gene is called wild-type KRAS. Tucatinib and trastuzumab both work by targeting and blocking HER2. When HER2 is blocked, the cancer may stop growing, or it may grow more slowly, and the cancer cells may shrink. In other research studies, the study drugs have been shown to work better when used to treat colorectal cancer with KRAS wild-type compared to KRAS mutated tumors. CAPOX is a combination of two drugs (capecitabine and oxaliplatin) and used as standard chemotherapy in treatment of locally advanced rectal cancer. CAPOX works by damaging the deoxyribonucleic acid (DNA) in cancer cells, and may cause the cells to stop growing and die. FOLFOX is a combination of three drugs (fluorouracil, oxaliplatin, and leucovorin) also works by damaging the deoxyribonucleic acid (DNA) in cancer cells, and may cause the cells to stop growing and die. CAPOX and FOLFOX are considered standard care. Giving trastuzumab and tucatinib before standard CAPOX chemotherapy may help shrink or stabilize cancer in patients with rectal cancer.