{"id":"pertuzumab-perjeta","safety":{"commonSideEffects":[{"rate":"~60%","effect":"Diarrhea"},{"rate":"~40%","effect":"Nausea"},{"rate":"~35%","effect":"Fatigue"},{"rate":"~25%","effect":"Vomiting"},{"rate":"~20%","effect":"Rash"},{"rate":"~5-10%","effect":"Left ventricular dysfunction"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Pertuzumab targets the extracellular domain II of HER2, a different epitope than trastuzumab, and prevents HER2 from pairing with HER3 and other HER family members. This dual blockade of HER2 signaling pathways enhances anti-tumor activity compared to HER2 inhibition alone. It is used in combination with trastuzumab and chemotherapy to treat HER2-positive breast cancers.","oneSentence":"Pertuzumab is a monoclonal antibody that binds to HER2 and blocks its dimerization with other HER receptors, preventing cancer cell growth signaling.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:49:43.018Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"HER2-positive metastatic breast cancer (in combination with trastuzumab and chemotherapy)"},{"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":"NCT02693535","phase":"PHASE2","title":"TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer","status":"RECRUITING","sponsor":"American Society of Clinical Oncology","startDate":"2016-03-14","conditions":"Lymphoma, Non-Hodgkin, Multiple Myeloma, Advanced Solid Tumors","enrollment":4200},{"nctId":"NCT04802759","phase":"PHASE1, PHASE2","title":"A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer","status":"RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2021-06-22","conditions":"Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer","enrollment":316},{"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":"NCT07102381","phase":"PHASE2","title":"A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer","status":"RECRUITING","sponsor":"Jazz Pharmaceuticals","startDate":"2025-09-24","conditions":"HER2-positive Breast Cancer, Breast Cancer","enrollment":125},{"nctId":"NCT06686394","phase":"PHASE1, PHASE2","title":"Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)","status":"RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2025-02-26","conditions":"Breast Neoplasms, Breast Cancer","enrollment":81},{"nctId":"NCT05415215","phase":"PHASE3","title":"A Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2022-07-05","conditions":"Early Breast Cancer, Locally Advanced Breast Cancer, Inflammatory Breast Cancer","enrollment":346},{"nctId":"NCT07386938","phase":"PHASE3","title":"A Study of the Efficacy, Safety and Pharmacokinetics of RPH-051 and Perjeta® in Combination With Trastuzumab and Docetaxel as the 1st Line Therapy in Patients With HER2-positive Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"R-Pharm","startDate":"2024-08-09","conditions":"Locally Advanced Breast Cancer, Metastatic Breast Cancer","enrollment":246},{"nctId":"NCT01358877","phase":"PHASE3","title":"A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2011-11-08","conditions":"Breast Cancer","enrollment":4804},{"nctId":"NCT05954143","phase":"PHASE2","title":"Trial of BDC-1001 +/- Pertuzumab in Subjects With HER2-Positive Metastatic Breast Cancer","status":"TERMINATED","sponsor":"Bolt Biotherapeutics, Inc.","startDate":"2023-11-30","conditions":"Metastatic Breast Cancer, HER2-positive Breast Cancer","enrollment":11},{"nctId":"NCT05041842","phase":"PHASE2","title":"Treatment With Tucatinib in Patients With an Isolated Brain Progression of a Metastatic Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"UNICANCER","startDate":"2021-12-17","conditions":"Metastatic Breast Cancer With a Isolated Brain Progression","enrollment":53},{"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":"NCT04419181","phase":"PHASE2","title":"Feasibility of Chemotherapy De-escalation in Early-Stage HER2 Positive Breast Cancer","status":"WITHDRAWN","sponsor":"University of Rochester","startDate":"2025-08-11","conditions":"HER2-positive Breast Cancer","enrollment":""},{"nctId":"NCT03820063","phase":"PHASE2","title":"Image-guided De-escalation of Neo-adjuvant Chemotherapy in HER2-positive Breast Cancer: the TRAIN-3 Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"Borstkanker Onderzoek Groep","startDate":"2019-02-27","conditions":"Breast Cancer","enrollment":462},{"nctId":"NCT05802225","phase":"PHASE3","title":"Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Biocad","startDate":"2023-01-30","conditions":"Breast Cancer","enrollment":398},{"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":"NCT03161353","phase":"PHASE2","title":"Chemotherapy-free Trastuzumab and Pertuzumab in HER2-positive Breast Cancer: FDG-PET Response-adapted Strategy.","status":"ACTIVE_NOT_RECRUITING","sponsor":"MedSIR","startDate":"2017-06-26","conditions":"Breast Cancer","enrollment":377},{"nctId":"NCT06907082","phase":"NA","title":"Study to Evaluate the Efficacy and Safety of Neoadjuvant Treatment Based on Dual Blockade With Pertuzumab and the Trastuzumab Biosimilar CT-P6 (Herzuma®) in Early HER2-positive Breast Cancer in Routine Clinical Practice","status":"COMPLETED","sponsor":"Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia","startDate":"2020-12-28","conditions":"Breast Cancer","enrollment":106},{"nctId":"NCT04632992","phase":"PHASE2","title":"A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response","status":"COMPLETED","sponsor":"Genentech, Inc.","startDate":"2021-01-13","conditions":"Advanced Unresectable or Metastatic Solid Malignancy","enrollment":252},{"nctId":"NCT05275010","phase":"PHASE1","title":"A Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2022-05-30","conditions":"Healthy Male Subjects","enrollment":151},{"nctId":"NCT05825781","phase":"PHASE1","title":"Study, Evaluating Pharmacokinetics, Immunogenicity and Safety Profiles of Pertuzumab Compared to Perjeta® in Healthy Man","status":"ACTIVE_NOT_RECRUITING","sponsor":"Mabscale, LLC","startDate":"2023-07-20","conditions":"Healthy Men","enrollment":114},{"nctId":"NCT04957212","phase":"PHASE3","title":"Comparing Efficacy and Safety Between Pertuzumab® and Perjeta® in Neoadjuvant Treatment of HER2+ Breast Cancer","status":"COMPLETED","sponsor":"Cinnagen","startDate":"2018-08-11","conditions":"HER2-positive Breast Cancer","enrollment":214},{"nctId":"NCT05283837","phase":"PHASE3","title":"A Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Immunogenicity of Test Pertuzumab (ZRC-3277, Cadila Healthcare Ltd.,)","status":"COMPLETED","sponsor":"Zydus Lifesciences Limited","startDate":"2022-09-26","conditions":"Metastatic Breast Cancer","enrollment":268},{"nctId":"NCT02344472","phase":"PHASE3","title":"Detect V / CHEVENDO (Chemo vs. Endo)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Prof. Wolfgang Janni","startDate":"2015-09","conditions":"Metastatic Breast Cancer","enrollment":271},{"nctId":"NCT04629846","phase":"PHASE3","title":"Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive and Estrogen Receptor/Progesterone Receptor Negative Breast Cancer to Evaluate the Efficiency and Safety of Treatment With Trastuzumab Plus (+) QL1209/Pertuzumab + Docetaxel.","status":"COMPLETED","sponsor":"Qilu Pharmaceutical Co., Ltd.","startDate":"2020-11-23","conditions":"Breast Cancer","enrollment":517},{"nctId":"NCT03674112","phase":"PHASE2","title":"A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2018-12-19","conditions":"HER2-Positive Early Breast Cancer","enrollment":160},{"nctId":"NCT05978648","phase":"PHASE2","title":"Trilaciclib in Patients With Early-Stage HR-negative Breast Cancer Receiving Adjuvant Chemotherapy","status":"RECRUITING","sponsor":"wang shusen","startDate":"2023-09-20","conditions":"Breast Neoplasms","enrollment":116},{"nctId":"NCT05985187","phase":"PHASE3","title":"Clinical Study to Evaluate the Efficacy and Safety of TQB2440 Injection/Perjeta® Combined With Trastuzumab and Docetaxel in the Treatment of Patients With Early or Locally Advanced Breast Cancer.","status":"UNKNOWN","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","startDate":"2020-10-20","conditions":"HER2-positive Breast Cancer","enrollment":412},{"nctId":"NCT03988036","phase":"PHASE2","title":"A Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast Cancer Patients With Molecular HER2-enriched Intrinsic Subtype (Keyriched-1)","status":"COMPLETED","sponsor":"West German Study Group","startDate":"2020-08-18","conditions":"Breast Cancer","enrollment":46},{"nctId":"NCT03112590","phase":"PHASE1, PHASE2","title":"Phase I-II Study of Interferon-gamma in Patients With HER-2 Positive Breast Cancer","status":"COMPLETED","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","startDate":"2017-06-23","conditions":"Breast Cancer, Breast Cancer, Male, Breast Cancer Female","enrollment":51},{"nctId":"NCT05036005","phase":"PHASE4","title":"Neoadjuvant Ontruzant (SB3) in Patients With HER2-positive Early Breast Cancer: An Open-Label (NeoON)","status":"UNKNOWN","sponsor":"Institut fuer Frauengesundheit","startDate":"2021-07-11","conditions":"Breast Cancer, Breast Neoplasms, Breast Cancer Female","enrollment":108},{"nctId":"NCT01922921","phase":"PHASE1, PHASE2","title":"Vaccine Therapy With or Without Polysaccharide-K in Patients With Stage IV HER2 Positive Breast Cancer Receiving HER2-Targeted Monoclonal Antibody Therapy","status":"COMPLETED","sponsor":"University of Washington","startDate":"2014-02-05","conditions":"HER2/Neu Positive, Recurrent Breast Carcinoma, Stage IV Breast Cancer","enrollment":31},{"nctId":"NCT05738993","phase":"PHASE1","title":"A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single Intravenous Infusion of BCD-178 or Perjeta® in Healthy Volunteers","status":"UNKNOWN","sponsor":"Biocad","startDate":"2022-08-08","conditions":"Breast Cancer","enrollment":100},{"nctId":"NCT05720026","phase":"PHASE3","title":"Study to Evaluate the Efficacy and Safety of SYSA1901 vs. Perjeta® of HER2-Positive Breast Cancer","status":"UNKNOWN","sponsor":"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","startDate":"2023-01-09","conditions":"HER2-positive Breast Cancer","enrollment":560},{"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":"NCT04395508","phase":"","title":"An Expanded Access Study to Provide at Home Subcutaneous Administration of Pertuzumab and Trastuzumab Fixed-Dose Combination (PH FDC SC) for Patients With HER2-Positive Breast Cancer During the COVID-19 Pandemic","status":"APPROVED_FOR_MARKETING","sponsor":"Genentech, Inc.","startDate":"","conditions":"HER2-positive Breast Cancer","enrollment":""},{"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},{"nctId":"NCT05188495","phase":"","title":"Trastuzumab(Henlius®) Combined With Pertuzumab(Perjeta®) and Chemotherapy in Chinese Patients With Her2-Positive Metastatic Breast Cancer Previously Treated With Trastuzumab","status":"UNKNOWN","sponsor":"Peking University Cancer Hospital & Institute","startDate":"2021-05-10","conditions":"HER2-positive Metastatic Breast Cancer, Previously Treated With Trastuzumab, Trastuzumab Combined With Pertuzumab and Chemotherapy","enrollment":60},{"nctId":"NCT01847001","phase":"PHASE2","title":"Study of Propranolol in Newly Diagnosed Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy","status":"COMPLETED","sponsor":"Columbia University","startDate":"2012-10","conditions":"Locally Advanced Malignant Neoplasm, Breast Cancer","enrollment":10},{"nctId":"NCT04820439","phase":"PHASE1","title":"Pharmacokinetic Study of Recombinant Monoclonal Antibody Against Human Epidermal Growth Factor Receptor Injection","status":"COMPLETED","sponsor":"The Affiliated Hospital of Qingdao University","startDate":"2020-10-13","conditions":"Healthy Volunteers","enrollment":88},{"nctId":"NCT02139358","phase":"PHASE1, PHASE2","title":"Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer","status":"COMPLETED","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","startDate":"2014-09-05","conditions":"Breast Cancer","enrollment":15},{"nctId":"NCT01491737","phase":"PHASE2","title":"A Study of Pertuzumab in Combination With Trastuzumab Plus an Aromatase Inhibitor in Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive and Hormone Receptor-Positive Advanced Breast Cancer","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2012-02-17","conditions":"Breast Cancer","enrollment":258},{"nctId":"NCT03811418","phase":"PHASE3","title":"A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer","status":"WITHDRAWN","sponsor":"iOMEDICO AG","startDate":"2019-01","conditions":"Advanced Breast Cancer, HER2-positive Breast Cancer","enrollment":""},{"nctId":"NCT02445586","phase":"PHASE4","title":"Safety Study of Pertuzumab (in Combination With Trastuzumab and Docetaxel) in Indian Participants With Breast Cancer","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2015-08-17","conditions":"Breast Cancer","enrollment":52},{"nctId":"NCT02131064","phase":"PHASE3","title":"A Study Evaluating Trastuzumab Emtansine Plus Pertuzumab Compared With Chemotherapy Plus Trastuzumab and Pertuzumab for Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2014-06-25","conditions":"Breast Neoplasms","enrollment":444},{"nctId":"NCT02738970","phase":"PHASE1","title":"A Dose-Finding Study of Pertuzumab (Perjeta) in Combination With Trastuzumab (Herceptin) in Healthy Male Participants and Women With Early Breast Cancer (EBC)","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2016-06-23","conditions":"Early Breast Cancer","enrollment":88},{"nctId":"NCT01669239","phase":"PHASE2","title":"Study of Neoadjuvant Myocet®, Paclitaxel, Pertuzumab, and Trastuzumab in HER2-positive Breast Cancer","status":"COMPLETED","sponsor":"SOLTI Breast Cancer Research Group","startDate":"2013-06","conditions":"Breast Cancer","enrollment":83},{"nctId":"NCT02125344","phase":"PHASE3","title":"A Phase III Trial Comparing Two Dose-dense, Dose-intensified Approaches (ETC and PM(Cb)) for Neoadjuvant Treatment of Patients With High-risk Early Breast Cancer (GeparOcto)","status":"COMPLETED","sponsor":"GBG Forschungs GmbH","startDate":"2014-12","conditions":"Tubular Breast Cancer Stage II, Tubular Breast Cancer Stage III, Mucinous Breast Cancer Stage II","enrollment":961},{"nctId":"NCT01121939","phase":"PHASE2","title":"Combination of Bevacizumab, Pertuzumab, and Sandostatin for Adv. Neuroendocrine Cancers","status":"COMPLETED","sponsor":"SCRI Development Innovations, LLC","startDate":"2010-05","conditions":"Neuroendocrine Carcinoma","enrollment":43}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"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":"Pertuzumab (Perjeta®)","genericName":"Pertuzumab (Perjeta®)","companyName":"Zydus Lifesciences Limited","companyId":"zydus-lifesciences-limited","modality":"Biologic","firstApprovalDate":"","aiSummary":"Pertuzumab is a monoclonal antibody that binds to HER2 and blocks its dimerization with other HER receptors, preventing cancer cell growth signaling. Used for HER2-positive metastatic breast cancer (in combination with trastuzumab and chemotherapy), HER2-positive early breast cancer (neoadjuvant and adjuvant settings).","enrichmentLevel":3,"visitCount":2,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}