A Study of Tucatinib and Trastuzumab in People With Rectal Cancer
Trial Parameters
Brief Summary
The study researchers believe that a combination of the drugs trastuzumab and tucatinib, given with standard chemotherapy (capecitabine and oxaliplatin/FOLFOX), may help participants with rectal cancer.
Eligibility Criteria
Inclusion Criteria: * Willing and able to provide written informed consent for the trial. * Be ≥18 years of age on the date of signing informed consent. * ECOG performance status of 0 or 1. * Histologically confirmed rectal adenocarcinoma. * Adenocarcinoma with distal margin of 15 cm or less from the anal verge on endoscopy, staged with endorectal ultrasound (ERUS) or magnetic resonance imaging (MRI) as cT3/cT4 N0 or cT(any) cN1/2, * No evidence of distant metastases * Radiologically measurable or clinically evaluable disease per Protocol Section 13.0. * Have confirmed HER2-positive rectal adenocarcinoma, as defined by having tumor tissue tested at a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, meeting at least one of the following criteria: 1. HER2+ overexpression (3+ immunohistochemistry \[IHC\]) by an FDA-approved HER2 IHC test following the package insert's interpretational manual for gastric cancer 2. HER2 2+ IHC is eligible if the tumor is amplified by