{"id":"trastuzumab-bs","rwe":[],"tags":[],"phase":"preclinical","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"active","trials":["NCT03644186","NCT02693535","NCT04181333"],"aliases":[],"patents":[],"pricing":[],"allNames":"trastuzumab bs","offLabel":[],"timeline":[{"date":"2023","type":"neutral","milestone":"Phase 2 Initiated","description":"Phase 2 trial (To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Brea) — Breast Cancer"}],"aiSummary":"Trastuzumab BS is a biosimilar of the antibody drug trastuzumab, which is an inhibitor of the receptor tyrosine-protein kinase erbB-2. It is being studied for the treatment of unresectable advanced or recurrent HER2-overexpressing gastric cancer.","brandName":"TRASTUZUMAB BS","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"Monoclonal antibody","drugClass":"Regimen A or regimen B is used for HER2-overexpressing breast cancer.  RegimenB is used for HER2-ove","explanation":"Trastuzumab BS is a monoclonal antibody, which is essentially a specially designed protein that acts like a targeted missile. It locks onto a specific protein called HER2 that appears in excessive amounts on certain cancer cells. By binding to HER2, the drug blocks cancer cells from receiving growth signals that tell them to multiply and spread.\n\nBeyond simply blocking growth signals, trastuzumab BS recruits the body's immune system to attack and eliminate cancer cells displaying HER2. It does this by tagging cancer cells so that natural killer cells and other immune components recognize them as threats and destroy them. This dual mechanism—blocking growth and activating immunity—makes the drug effective against HER2-positive cancers.\n\nTrastuzumab BS is a biosimilar version of the original trastuzumab, meaning it is manufactured differently but performs the same function in the body. It is approved for treating HER2-positive breast cancer and gastric cancer, cancers where HER2 overexpression drives aggressive growth. The biosimilar designation allows patients access to this important therapy with similar outcomes potentially at lower cost.","oneSentence":"Regimen A or regimen B is used for HER2-overexpressing breast cancer.  RegimenB is used for HER2-ove","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[],"genericName":"trastuzumab-bs","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Gastric Cancer","phase":"preclinical","trialId":"","patients":null,"diseaseId":"oncology","trialName":"","primaryEndpoint":"","expectedCompletion":""}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT03644186","phase":"Phase 2","title":"To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Brea","status":"Completed","sponsor":"ETOP IBCSG Partners Foundation","isPivotal":false,"enrollment":147,"indication":"Breast Cancer","completionDate":"2023-01","primaryEndpoint":"This is a phase II open-label, multicentre, randomized trial."},{"nctId":"NCT02693535","phase":"Phase 2","title":"TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific A","status":"Recruiting","sponsor":"American Society of Clinical Oncology","isPivotal":false,"enrollment":4200,"indication":"Lymphoma, Non-Hodgkin","completionDate":"2027-12","primaryEndpoint":"The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or "},{"nctId":"NCT04181333","phase":"N/A","title":"Safety and Efficacy of Trastuzumab BS","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":8,"indication":"Gastric Cancer","completionDate":"2025-03","primaryEndpoint":"To confirm the safety and efficacy of this drug under the actual use"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"crossReferences":{"chemblId":"CHEMBL1201585"},"formularyStatus":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Oncology"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Monoclonal antibody","enrichmentLevel":3,"visitCount":3,"trialStats":{"total":1,"withResults":1},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}