{"id":"trastuzumab-eu","safety":{"commonSideEffects":[{"rate":"20-40%","effect":"Fatigue"},{"rate":"20-40%","effect":"Nausea"},{"rate":"10-30%","effect":"Diarrhea"},{"rate":"10-30%","effect":"Headache"},{"rate":"10-30%","effect":"Musculoskeletal pain"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"It works by binding to the HER2 protein on the surface of cancer cells, which can help slow or stop the growth of the tumor. This is particularly useful for treating cancers that overexpress the HER2 protein, such as certain types of breast cancer.","oneSentence":"Trastuzumab-EU is a monoclonal antibody that targets the HER2/neu receptor.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:39:56.625Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Adjuvant treatment of HER2-positive breast cancer"},{"name":"Treatment of HER2-positive metastatic breast cancer"}]},"trialDetails":[{"nctId":"NCT07495930","phase":"PHASE1","title":"A Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 and EU-Phesgo®.","status":"NOT_YET_RECRUITING","sponsor":"Shanghai Henlius Biotech","startDate":"2026-04-30","conditions":"Health Adult Subjects","enrollment":24},{"nctId":"NCT06038539","phase":"PHASE3","title":"Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer","status":"TERMINATED","sponsor":"Biocon Biologics UK Ltd","startDate":"2025-01-06","conditions":"HR Negative HER2 Positive Early Breast Cancer or Locally Advanced Breast Cancer Patients","enrollment":55},{"nctId":"NCT06016387","phase":"PHASE2","title":"Tucatinib, Trastuzumab and Capecitabine With Brain and/or Spinal Radiotherapy (XRT) in Patients With HER2+, HER2 Mutated and/or HER2-amplified Metastatic Breast Cancer and Leptomeningeal Disease: A Multi-centre Phase II, Single Arm Feasibility Study","status":"RECRUITING","sponsor":"Sunnybrook Health Sciences Centre","startDate":"2023-11-25","conditions":"HER2-positive Breast Cancer, LMD","enrollment":30},{"nctId":"NCT06884254","phase":"PHASE3","title":"Efficacy and Safety Study of EG1206A (EirGenix' Pertuzumab) Compared With EU-sourced Perjeta® (Pertuzumab) in Patients With HER2-positive Hormone Receptor Negative Early Breast Cancer.","status":"WITHDRAWN","sponsor":"EirGenix, Inc.","startDate":"2025-05","conditions":"Early Breast Cancer","enrollment":""},{"nctId":"NCT06687928","phase":"PHASE1","title":"To Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects (Trastuzumab)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Celltrion","startDate":"2025-03-25","conditions":"Healthy","enrollment":200},{"nctId":"NCT05346224","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Shanghai Henlius Biotech","startDate":"2022-04-25","conditions":"Breast Cancer, Breast Neoplasms, HER2-positive Breast Cancer","enrollment":900},{"nctId":"NCT03776240","phase":"PHASE1","title":"A Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD201 and EU-Herceptin® and US-Herceptin® in Healthy Male Subjects","status":"COMPLETED","sponsor":"Prestige Biopharma Limited","startDate":"2019-04-01","conditions":"Healthy Volunteers","enrollment":105},{"nctId":"NCT03084237","phase":"PHASE3","title":"Compare Efficacy, Safety and Immunogenicity of HLX02 and Herceptin in Previously Untreated HER2 +Overexpressing Metastatic Breast Cancer","status":"COMPLETED","sponsor":"Shanghai Henlius Biotech","startDate":"2016-11","conditions":"Breast Cancer","enrollment":652},{"nctId":"NCT04670796","phase":"PHASE1","title":"A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(US-licensed and EU-approved) in Healthy Chinese Male Subjects","status":"COMPLETED","sponsor":"Shanghai Henlius Biotech","startDate":"2021-03-02","conditions":"Healthy","enrollment":111},{"nctId":"NCT01989676","phase":"PHASE3","title":"A Study Of PF-05280014 [Trastuzumab-Pfizer] Or Herceptin® [Trastuzumab-EU] Plus Paclitaxel In HER2 Positive First Line Metastatic Breast Cancer Treatment (REFLECTIONS B327-02)","status":"COMPLETED","sponsor":"Pfizer","startDate":"2014-02-24","conditions":"Metastatic Breast Cancer","enrollment":707},{"nctId":"NCT02187744","phase":"PHASE3","title":"A Study Of PF-05280014 Or Trastuzumab Plus Taxotere® And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04)","status":"COMPLETED","sponsor":"Pfizer","startDate":"2014-09-23","conditions":"Early Breast Cancer","enrollment":226},{"nctId":"NCT02075073","phase":"PHASE1","title":"Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB3 in Healthy Male Subjects","status":"COMPLETED","sponsor":"Samsung Bioepis Co., Ltd.","startDate":"2014-02","conditions":"Healthy","enrollment":109},{"nctId":"NCT03242239","phase":"PHASE1","title":"A Comparing Study Between ALT02(Trastuzumab Biosimilar) and Herceptin® in Healthy Subjects","status":"COMPLETED","sponsor":"Alteogen, Inc.","startDate":"2016-02-09","conditions":"Healthy","enrollment":105},{"nctId":"NCT03180242","phase":"PHASE1","title":"A Pharmacokinetic Study Comparing EG12014 and Herceptin (Trastuzumab) in Healthy Male Volunteers","status":"COMPLETED","sponsor":"EirGenix, Inc.","startDate":"2016-03-22","conditions":"Healthy","enrollment":84},{"nctId":"NCT02594761","phase":"PHASE1","title":"Phase 1 Study of Trastuzumab Administered as a Single Intravenous Infusion","status":"COMPLETED","sponsor":"Mylan Pharmaceuticals Inc","startDate":"2013-08","conditions":"Healthy","enrollment":132},{"nctId":"NCT01603264","phase":"PHASE1","title":"A Pharmacokinetic Study Comparing PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-01)","status":"COMPLETED","sponsor":"Pfizer","startDate":"2012-05","conditions":"Healthy","enrollment":105}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":10,"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":"Trastuzumab-EU","genericName":"Trastuzumab-EU","companyName":"Pfizer","companyId":"pfizer","modality":"Biologic","firstApprovalDate":"","aiSummary":"Trastuzumab-EU is a biosimilar of the antibody drug Trastuzumab, which is an inhibitor of the receptor tyrosine-protein kinase erbB-2. It is used to treat HER2-positive early breast cancer or locally advanced breast cancer.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}