{"id":"tx05-trastuzumab","safety":{"commonSideEffects":[{"rate":"5-27%","effect":"Cardiotoxicity / left ventricular dysfunction"},{"rate":"20-40%","effect":"Infusion reactions"},{"rate":"20-30%","effect":"Nausea"},{"rate":"15-25%","effect":"Diarrhea"},{"rate":"20-30%","effect":"Fatigue"},{"rate":"10-20%","effect":"Headache"},{"rate":"10-20%","effect":"Fever"}]},"_chembl":{"chemblId":"CHEMBL1201585","moleculeType":"Antibody"},"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"Trastuzumab targets human epidermal growth factor receptor 2 (HER2), a protein overexpressed in certain cancers. By binding to HER2, it prevents ligand-induced signaling and recruits immune cells to destroy HER2-positive tumor cells through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).","oneSentence":"Trastuzumab is a monoclonal antibody that binds to HER2 receptors on cancer cells, blocking growth signals and triggering immune-mediated cell death.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:51:43.789Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"HER2-positive metastatic breast cancer"},{"name":"HER2-positive early-stage breast cancer (adjuvant/neoadjuvant)"},{"name":"HER2-positive metastatic gastric cancer"}]},"trialDetails":[{"nctId":"NCT04109391","phase":"PHASE3","title":"Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03","status":"COMPLETED","sponsor":"Tanvex BioPharma USA, Inc.","startDate":"2019-08-20","conditions":"HER2-positive Breast Cancer, Early-stage Breast Cancer, Breast Cancer","enrollment":338},{"nctId":"NCT03556358","phase":"PHASE3","title":"Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer","status":"COMPLETED","sponsor":"Tanvex BioPharma USA, Inc.","startDate":"2018-06-28","conditions":"Breast Cancer, Breast Neoplasms, HER2-positive Breast Cancer","enrollment":809}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":15669,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"TX05 (trastuzumab)","genericName":"TX05 (trastuzumab)","companyName":"Tanvex BioPharma USA, Inc.","companyId":"tanvex-biopharma-usa-inc","modality":"Biologic","firstApprovalDate":"","aiSummary":"TX05 (trastuzumab) is a biosimilar antibody that targets the Receptor tyrosine-protein kinase erbB-2, a receptor protein-tyrosine kinase inhibitor. It is being studied for the treatment of HER2-positive Breast Cancer, specifically in early breast cancer, in a randomized, double-blind, Phase III trial.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}