A RANDOMIZED, MULTICENTER, ADAPTIVE PHASE II/III STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TRASTUZUMAB EMTANSINE (T-DM1) VERSUS TAXANE (DOCETAXEL OR PACLITAXEL) IN PATIENTS WITH PREVIOUSLY TREATED LOCALLY ADVANCED OR METASTATIC HER2-POSITIVE GASTRIC CANCER, INCLUDING ADENOCARCINOMA OF THE GASTROESOPHAGEAL JUNCTION
Diseases and Conditions Researched
Adenocarcinoma of the Gastroesophageal Junction; Esophagus; Gastric Cancer; Stomach
What is the purpose of this trial?
Trastuzumab emtansine is an investigational drug being studied by F. Hoffmann La Roche Ltd (Roche) and Yale Cancer Center for treating advanced gastric cancer. Trastuzumab emtansine is composed of a chemotherapeutic agent (DM1) linked to Herceptin® (trastuzumab), a monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer) that attaches to protein called HER2 on cancer cells. Trastuzumab emtansine has caused cancer cells to die in laboratory studies and has slowed tumor growth in animal studies. In clinical trials, some patients given trastuzumab emtansine experienced tumor shrinkage. Trastuzumab emtansine is produced by Roche. The use of trastuzumab emtansine in this research study is experimental, which means that it is not approved for the treatment of HER2 positive advanced gastric cancer or adenocarcinoma of the gastroesophageal junction.
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