{"id":"eu-perjeta","safety":{"commonSideEffects":[{"rate":"30–40%","effect":"Diarrhea"},{"rate":"25–35%","effect":"Nausea"},{"rate":"20–30%","effect":"Fatigue"},{"rate":"15–25%","effect":"Rash"},{"rate":"15–20%","effect":"Vomiting"},{"rate":"5–10%","effect":"Left ventricular dysfunction"}]},"_chembl":{"chemblId":"CHEMBL5857501","moleculeType":null,"molecularWeight":"542.39"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"EU-Perjeta (pertuzumab) is a HER2-directed monoclonal antibody that prevents HER2 from binding to its ligands and forming active dimers with other HER receptors, thereby disrupting downstream signaling pathways that drive cancer cell proliferation. It is often used in combination with trastuzumab (Herceptin) and chemotherapy to enhance anti-tumor activity in HER2-positive breast cancers.","oneSentence":"EU-Perjeta is a monoclonal antibody that binds to HER2 and blocks its dimerization with other HER family receptors, inhibiting tumor cell growth signaling.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:11:47.759Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"HER2-positive metastatic breast cancer"},{"name":"HER2-positive early breast cancer (neoadjuvant and adjuvant settings)"}]},"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":"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Perjeta® (Pertuzumab) in Patients With HER2-positive Hormone Receptor Negative Early Breast Cancer.","status":"WITHDRAWN","sponsor":"EirGenix, Inc.","startDate":"2025-05","conditions":"Early Breast Cancer","enrollment":""},{"nctId":"NCT05346224","phase":"PHASE3","title":"A Study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":"NCT05471648","phase":"PHASE1","title":"A Pharmacokinetic Study Comparing EG1206A and Perjeta (Pertzumab) in Healthy Male Volunteers","status":"COMPLETED","sponsor":"EirGenix, Inc.","startDate":"2022-05-16","conditions":"Breast Cancer","enrollment":135},{"nctId":"NCT04411550","phase":"PHASE1","title":"Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta in Healthy Chinese Male Subjects","status":"COMPLETED","sponsor":"Shanghai Henlius Biotech","startDate":"2020-07-01","conditions":"Healthy Male Volunteers","enrollment":160}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"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":"EU-Perjeta®","genericName":"EU-Perjeta®","companyName":"Shanghai Henlius Biotech","companyId":"shanghai-henlius-biotech","modality":"Small molecule","firstApprovalDate":"","aiSummary":"EU-Perjeta is a monoclonal antibody that binds to HER2 and blocks its dimerization with other HER family receptors, inhibiting tumor cell growth signaling. Used for HER2-positive metastatic breast cancer, HER2-positive early breast cancer (neoadjuvant and adjuvant settings).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}