{"entity":{"id":"trastuzumab","kind":"drug","name":"Trastuzumab","aka":["Trastuzumab and Hyaluronidase-oysk","Herceptin Hylecta"],"tldr":"The first targeted antibody for a solid tumour (1998), which turned HER2-positive breast cancer from the worst subtype into one of the most treatable.","summary":"Trastuzumab is a humanised IgG1 antibody that binds domain IV of HER2, blocking receptor signalling and recruiting immune cells through ADCC. It was the first targeted antibody for a solid tumour, approved for HER2-positive metastatic breast cancer in 1998, as adjuvant therapy in 2006 (HERA, NSABP B-31/N9831, about a 37% reduction in death) and for HER2-positive gastric cancer in 2010. Dual blockade with pertuzumab (CLEOPATRA, APHINITY) and the subcutaneous Phesgo built on it, and it is the antibody backbone of the conjugates T-DM1 and T-DXd. Adjuvant treatment lasts 1 year, and cardiomyopathy requires LVEF monitoring. Biosimilars since 2017 have cut cost worldwide, and whether shorter adjuvant courses are safe for lower-risk patients remains debated. For a newcomer: the drug that turned the worst breast cancer subtype into one of the most treatable.","status":"approved","asOf":"2026-09-04","wikipedia":"https://en.wikipedia.org/wiki/Trastuzumab","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Trastuzumab"}],"tags":[],"related":["tucatinib-triplet-brain-mets","her2-ihc-3-plus","her2-ish-amplified"],"cancers":["breast-her2-positive","gastric","gastric-her2-positive","salivary-duct-carcinoma","her2-positive-early-breast-cancer","endometrial-p53-abnormal","colorectal","gallbladder","biliary-tract-cancer"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["her2"],"drugs":[],"companies":["roche-genentech","nippon-kayaku","halozyme"],"institutions":[],"pathways":[],"terms":[],"trials":["nct07518173","nct06435429","nct07196774","nct06891833","nct04430738","nct05081609","nct06324357","nct07102381","nct06589830","nct05458674","nct05980481","nct06731478","nct03379428","nct07497386","nct05785741","nct06057610","nct06764875","nct04208178","nct06771622","nct04873362","nct07047365","nct00781612","nct07007559","nct06686394","nct02320435","nct05417594","nct07315750","nct04379596","nct07069712","nct07679360","nct04721977","nct04579380","mountaineer","nct07140393"],"people":[],"bottlenecks":[],"keyPapers":["paper-sartore-bianchi-heracles-trastuzumab-lapatinib-lancet-oncol-2016","paper-toga-trastuzumab-gastric-lancet-2010","paper-valtorta-her2-scoring-colorectal-heracles-mod-pathol-2015","paper-bertotti-xenopatients-her2-cetuximab-resistant-colorectal-cancer-discov-2011","paper-javle-mypathway-her2-biliary-lancet-oncol-2021"],"journals":[],"dependsOn":[],"notes":["Colorectal cancer biomarkers: HER2 positivity by the HERACLES criteria, intense membranous staining in more than 50% of cells corresponding to homogeneous amplification, in a RAS wild-type tumour. That is about 5% of RAS wild-type patients, so roughly 20 must be screened to find one (Valtorta 2015, Sartore-Bianchi 2016). The combination with lapatinib gave 8 responses in 27 patients and has since been superseded by tucatinib plus trastuzumab and trastuzumab deruxtecan.","Biliary tract cancer: with pertuzumab, objective response rate 23% (9 of 39) in previously treated HER2-positive disease in the MyPathway basket (Javle 2021); off-label."],"brand":"Herceptin (and biosimilars, Phesgo with pertuzumab)","modality":"Monoclonal antibody (anti-HER2)","mechanism":"Humanised IgG1 binding HER2 ECD4; signal inhibition and ADCC.","approvals":[{"region":"US","year":1998,"indication":"HER2+ metastatic breast cancer"},{"region":"US","year":2006,"indication":"Adjuvant HER2+ breast cancer"},{"region":"US","year":2010,"indication":"HER2+ gastric cancer"}],"mechanismSteps":["Antibody binds domain IV of HER2","HER2 signalling and shedding are inhibited; receptor internalisation increases","Fc engages NK cells: antibody-dependent cellular cytotoxicity","HER2-amplified cells stop proliferating and are cleared","With pertuzumab, dimerisation with HER3 is also blocked"],"dosing":{"route":"IV infusion (subcutaneous Herceptin Hylecta / Phesgo with pertuzumab available)","schedule":"8 mg/kg loading then 6 mg/kg every 3 weeks (or 4 then 2 mg/kg weekly); 1 year adjuvant","modifications":"Hold for LVEF drop ≥16 points or below normal","monitoring":"LVEF at baseline and every 3 months during therapy; infusion reactions","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},"toxicity":[{"event":"Cardiomyopathy / LVEF decline","note":"Adjuvant trials: ~2-4% symptomatic heart failure with anthracyclines"},{"event":"Infusion reactions"},{"event":"Fever"},{"event":"Nausea"},{"event":"Diarrhoea"},{"event":"Pulmonary toxicity (rare)"}],"access":[{"country":"US","reimbursement":"Medicare Part B; five biosimilars available since 2019, roughly 15-35% below reference price","assistance":"https://www.genentech-access.com","generic":true,"source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"},{"country":"UK","reimbursement":"NICE: standard of care; biosimilars widely used","source":"https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"1998-09-25","type":"approval","region":"US","note":"HER2+ metastatic breast cancer: first targeted antibody for a solid tumour","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2006-11-16","type":"approval","region":"US","note":"Adjuvant HER2+ early breast cancer (HERA, NSABP B-31/N9831)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2010-10-20","type":"approval","region":"US","note":"HER2+ metastatic gastric cancer (ToGA)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2017-12-01","type":"approval","region":"US","note":"First trastuzumab biosimilar (Ogivri)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2019-02-28","type":"approval","region":"US","note":"Subcutaneous trastuzumab-hyaluronidase (Herceptin Hylecta)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2020-06-29","type":"approval","region":"US","note":"Phesgo (pertuzumab, trastuzumab, hyaluronidase) subcutaneous","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2026-06-24","type":"approval","region":"US","note":"FDA approves palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of HR-positive, HER2-positive metastatic breast cancer","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-palbociclib-trastuzumab-or-without-pertuzumab-and-endocrine-therapy-maintenance"}]},"route":"/drugs/trastuzumab/","neighbours":{"pairing":[{"id":"pet-adapted-her2-deescalation","kind":"pairing","name":"Early FDG-PET response → chemotherapy omission (HER2+)","route":"/pairings/pet-adapted-her2-deescalation/"},{"id":"her2-gastric-sequence","kind":"pairing","name":"HER2 sequence in gastric cancer: zanidatamab/trastuzumab + chemo ± PD-1 → T-DXd","route":"/pairings/her2-gastric-sequence/"},{"id":"tucatinib-triplet-brain-mets","kind":"pairing","name":"Tucatinib + trastuzumab + capecitabine for brain metastases","route":"/pairings/tucatinib-triplet-brain-mets/"}],"biomarker":[{"id":"her2-ihc-2-plus","kind":"biomarker","name":"HER2 IHC 2+ (equivocal, reflex to ISH)","route":"/biomarkers/her2-ihc-2-plus/"},{"id":"her2-ihc-3-plus","kind":"biomarker","name":"HER2 IHC 3+ (HER2-positive by immunohistochemistry)","route":"/biomarkers/her2-ihc-3-plus/"},{"id":"her2-ish-amplified","kind":"biomarker","name":"HER2 ISH amplified (ERBB2 gene amplification)","route":"/biomarkers/her2-ish-amplified/"},{"id":"ras-wild-type","kind":"biomarker","name":"RAS wild-type (extended KRAS and NRAS testing)","route":"/biomarkers/ras-wild-type/"}],"cancer":[{"id":"advanced-recurrent-endometrial-cancer","kind":"cancer","name":"Advanced or recurrent endometrial cancer","route":"/cancers/advanced-recurrent-endometrial-cancer/"},{"id":"biliary-tract-cancer","kind":"cancer","name":"Biliary tract cancer (all types)","route":"/cancers/biliary-tract-cancer/"},{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"her2-positive-early-breast-cancer","kind":"cancer","name":"Early HER2-positive breast cancer","route":"/cancers/her2-positive-early-breast-cancer/"},{"id":"endometrial","kind":"cancer","name":"Endometrial cancer","route":"/cancers/endometrial/"},{"id":"gallbladder","kind":"cancer","name":"Gallbladder cancer","route":"/cancers/gallbladder/"},{"id":"gastric","kind":"cancer","name":"Gastric & gastro-oesophageal junction cancer","route":"/cancers/gastric/"},{"id":"her2-amplified-colorectal","kind":"cancer","name":"HER2-amplified colorectal cancer","route":"/cancers/her2-amplified-colorectal/"},{"id":"her2-low-metastatic-breast-cancer","kind":"cancer","name":"HER2-low and HER2-ultralow metastatic breast cancer","route":"/cancers/her2-low-metastatic-breast-cancer/"},{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"},{"id":"her2-positive-breast-brain-metastases","kind":"cancer","name":"HER2-positive breast cancer with brain metastases","route":"/cancers/her2-positive-breast-brain-metastases/"},{"id":"gastric-her2-positive","kind":"cancer","name":"HER2-positive gastric cancer","route":"/cancers/gastric-her2-positive/"},{"id":"inflammatory-breast-cancer","kind":"cancer","name":"Inflammatory breast cancer","route":"/cancers/inflammatory-breast-cancer/"},{"id":"male-breast-cancer","kind":"cancer","name":"Male breast cancer","route":"/cancers/male-breast-cancer/"},{"id":"mucinous-ovarian-cancer","kind":"cancer","name":"Mucinous ovarian cancer","route":"/cancers/mucinous-ovarian-cancer/"},{"id":"oesophageal-adenocarcinoma","kind":"cancer","name":"Oesophageal and junctional adenocarcinoma","route":"/cancers/oesophageal-adenocarcinoma/"},{"id":"esophageal","kind":"cancer","name":"Oesophageal cancer","route":"/cancers/esophageal/"},{"id":"endometrial-p53-abnormal","kind":"cancer","name":"p53-abnormal endometrial cancer, including uterine serous carcinoma","route":"/cancers/endometrial-p53-abnormal/"},{"id":"paget-disease-of-the-nipple","kind":"cancer","name":"Paget disease of the nipple","route":"/cancers/paget-disease-of-the-nipple/"},{"id":"salivary-duct-carcinoma","kind":"cancer","name":"Salivary duct carcinoma","route":"/cancers/salivary-duct-carcinoma/"},{"id":"salivary-gland","kind":"cancer","name":"Salivary gland cancers","route":"/cancers/salivary-gland/"}],"technology":[{"id":"biosimilar-manufacturing","kind":"technology","name":"Biosimilar manufacturing and comparability","route":"/technologies/biosimilar-manufacturing/"},{"id":"downstream-purification-chromatography","kind":"technology","name":"Downstream purification (Protein A capture, viral clearance, polishing)","route":"/technologies/downstream-purification-chromatography/"},{"id":"cardiotoxicity-surveillance-recovery","kind":"technology","name":"Heart function after anthracyclines, trastuzumab and chest radiotherapy","route":"/technologies/cardiotoxicity-surveillance-recovery/"},{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"},{"id":"anthracycline-cardioprotection","kind":"technology","name":"Protecting the heart during anthracycline treatment: dexrazoxane, beta blockers and ACE inhibitors","route":"/technologies/anthracycline-cardioprotection/"},{"id":"strain-echocardiography-gls","kind":"technology","name":"Strain echocardiography (global longitudinal strain)","route":"/technologies/strain-echocardiography-gls/"},{"id":"transcranial-focused-ultrasound-systems","kind":"technology","name":"Transcranial focused ultrasound systems (Exablate Neuro, SonoCloud)","route":"/technologies/transcranial-focused-ultrasound-systems/"},{"id":"cardiac-biomarker-monitoring","kind":"technology","name":"Troponin and natriuretic peptide monitoring during cancer treatment","route":"/technologies/cardiac-biomarker-monitoring/"},{"id":"rejuv-recovery-matrix","kind":"technology","name":"What comes back after treatment, treatment by treatment","route":"/technologies/rejuv-recovery-matrix/"}],"target":[{"id":"her2","kind":"target","name":"HER2","route":"/targets/her2/"}],"company":[{"id":"biocon","kind":"company","name":"Biocon","route":"/companies/biocon/"},{"id":"biocon-biologics","kind":"company","name":"Biocon Biologics","route":"/companies/biocon-biologics/"},{"id":"breast-cancer-trials","kind":"company","name":"Breast Cancer Trials","route":"/companies/breast-cancer-trials/"},{"id":"big","kind":"company","name":"Breast International Group (BIG)","route":"/companies/big/"},{"id":"halozyme","kind":"company","name":"Halozyme Therapeutics","route":"/companies/halozyme/"},{"id":"nippon-kayaku","kind":"company","name":"Nippon Kayaku","route":"/companies/nippon-kayaku/"},{"id":"nsabp-foundation","kind":"company","name":"NSABP Foundation","route":"/companies/nsabp-foundation/"},{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"},{"id":"samsung-bioepis","kind":"company","name":"Samsung Bioepis","route":"/companies/samsung-bioepis/"},{"id":"solti","kind":"company","name":"SOLTI Cancer Research Group","route":"/companies/solti/"}],"trial":[{"id":"nct07102381","kind":"trial","name":"A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer","route":"/trials/nct07102381/"},{"id":"nct06764875","kind":"trial","name":"A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer","route":"/trials/nct06764875/"},{"id":"nct06057610","kind":"trial","name":"A Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or Metastatic Breast Cancer","route":"/trials/nct06057610/"},{"id":"nct02320435","kind":"trial","name":"A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial","route":"/trials/nct02320435/"},{"id":"nct00781612","kind":"trial","name":"A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies","route":"/trials/nct00781612/"},{"id":"nct06435429","kind":"trial","name":"A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment o","route":"/trials/nct06435429/"},{"id":"nct04873362","kind":"trial","name":"A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy","route":"/trials/nct04873362/"},{"id":"nct07518173","kind":"trial","name":"A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or M","route":"/trials/nct07518173/"},{"id":"nct06891833","kind":"trial","name":"A Study of BL-M07D1 With or Without Pertuzumab Versus Docetaxel + Carboplatin + Trastuzumab + Pertuzumab in Neoadjuvant Therapy for HER2-Positive Brea","route":"/trials/nct06891833/"},{"id":"nct05785741","kind":"trial","name":"A Study of DB-1310 in Advanced/Metastatic Solid Tumors","route":"/trials/nct05785741/"},{"id":"nct07315750","kind":"trial","name":"A Study of Disitamab Vedotin Combined With Trastuzumab and Tislelizumab Versus Chemotherapy Combined With Trastuzumab With or Without Pembrolizumab in HER2-high Expression Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.","route":"/trials/nct07315750/"},{"id":"nct07140393","kind":"trial","name":"A Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor","route":"/trials/nct07140393/"},{"id":"nct07069712","kind":"trial","name":"A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma","route":"/trials/nct07069712/"},{"id":"nct05980481","kind":"trial","name":"A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer","route":"/trials/nct05980481/"},{"id":"nct07679360","kind":"trial","name":"A Study of Trastuzumab Rezetecan in Combination With Adebrelimab Versus Investigator's Choice of Therapy in Subjects With Residual Triple Negative Breast Cancer","route":"/trials/nct07679360/"},{"id":"nct04721977","kind":"trial","name":"A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-001)","route":"/trials/nct04721977/"},{"id":"nct05672524","kind":"trial","name":"A Study of Tucatinib and Trastuzumab in People With Rectal Cancer","route":"/trials/nct05672524/"},{"id":"nct05081609","kind":"trial","name":"A Study to Investigate Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab and/or TransCon TLR7/8 Agonist or Other","route":"/trials/nct05081609/"},{"id":"nct07196774","kind":"trial","name":"A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer","route":"/trials/nct07196774/"},{"id":"nct07497386","kind":"trial","name":"A Trial of Trastuzumab Rezetecan in Unresectable Locally Recurrent/Metastatic Breast Cancer","route":"/trials/nct07497386/"},{"id":"aphinity","kind":"trial","name":"APHINITY","route":"/trials/aphinity/"},{"id":"apt-trial","kind":"trial","name":"APT (adjuvant paclitaxel-trastuzumab)","route":"/trials/apt-trial/"},{"id":"nct07007559","kind":"trial","name":"ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer","route":"/trials/nct07007559/"},{"id":"atempt","kind":"trial","name":"ATEMPT","route":"/trials/atempt/"},{"id":"nct04579380","kind":"trial","name":"Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations","route":"/trials/nct04579380/"},{"id":"nct06324357","kind":"trial","name":"Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People Wit","route":"/trials/nct06324357/"},{"id":"nct01275677","kind":"trial","name":"Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer","route":"/trials/nct01275677/"},{"id":"cleopatra","kind":"trial","name":"CLEOPATRA","route":"/trials/cleopatra/"},{"id":"nct00016276","kind":"trial","name":"Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer","route":"/trials/nct00016276/"},{"id":"nct04082364","kind":"trial","name":"Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer","route":"/trials/nct04082364/"},{"id":"cupisco","kind":"trial","name":"CUPISCO","route":"/trials/cupisco/"},{"id":"determine-trial","kind":"trial","name":"DETERMINE","route":"/trials/determine-trial/"},{"id":"determine-arm04","kind":"trial","name":"DETERMINE arm 04: trastuzumab with pertuzumab in HER2-amplified or mutated rare cancers","route":"/trials/determine-arm04/"},{"id":"nct02003209","kind":"trial","name":"Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer","route":"/trials/nct02003209/"},{"id":"nct07059338","kind":"trial","name":"Dual EGFR/HER2 Blockade Combined With Irinotecan for the Treatment of HER2-Positive Metastatic Colorectal Cancer","route":"/trials/nct07059338/"},{"id":"nct05749900","kind":"trial","name":"First-line Trastuzumab, Gemcitabine, Cisplatin and Nivolumab in Advanced HER2- Positive Biliary Tract Cancer: a Multicenter, Open-label, Single-arm Phase Ib/II Trial (HERBOT)","route":"/trials/nct05749900/"},{"id":"geparsixto","kind":"trial","name":"GeparSixto","route":"/trials/geparsixto/"},{"id":"her2climb","kind":"trial","name":"HER2CLIMB","route":"/trials/her2climb/"},{"id":"her2climb-05","kind":"trial","name":"HER2CLIMB-05","route":"/trials/her2climb-05/"},{"id":"hera-b31-n9831","kind":"trial","name":"HERA, NSABP B-31 & NCCTG N9831 (adjuvant trastuzumab)","route":"/trials/hera-b31-n9831/"},{"id":"heracles","kind":"trial","name":"HERACLES","route":"/trials/heracles/"},{"id":"herizon-gea-01","kind":"trial","name":"HERIZON-GEA-01","route":"/trials/herizon-gea-01/"},{"id":"nct03803553","kind":"trial","name":"Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer","route":"/trials/nct03803553/"},{"id":"katherine","kind":"trial","name":"KATHERINE","route":"/trials/katherine/"},{"id":"keynote-811","kind":"trial","name":"KEYNOTE-811","route":"/trials/keynote-811/"},{"id":"kristine","kind":"trial","name":"KRISTINE","route":"/trials/kristine/"},{"id":"nct04425018","kind":"trial","name":"MARGetuximab Or Trastuzumab (MARGOT)","route":"/trials/nct04425018/"},{"id":"nct02492711","kind":"trial","name":"Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer","route":"/trials/nct02492711/"},{"id":"mountaineer","kind":"trial","name":"MOUNTAINEER","route":"/trials/mountaineer/"},{"id":"mountaineer-03","kind":"trial","name":"MOUNTAINEER-03","route":"/trials/mountaineer-03/"},{"id":"mypathway","kind":"trial","name":"MyPathway","route":"/trials/mypathway/"},{"id":"neosphere","kind":"trial","name":"NeoSphere","route":"/trials/neosphere/"},{"id":"nct07527806","kind":"trial","name":"Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET/CT Molecular Imaging","route":"/trials/nct07527806/"},{"id":"patina","kind":"trial","name":"PATINA","route":"/trials/patina/"},{"id":"persephone","kind":"trial","name":"PERSEPHONE","route":"/trials/persephone/"},{"id":"nct04379596","kind":"trial","name":"Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)","route":"/trials/nct04379596/"},{"id":"phergain","kind":"trial","name":"PHERGain","route":"/trials/phergain/"},{"id":"nct00769379","kind":"trial","name":"Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy","route":"/trials/nct00769379/"},{"id":"nct07366840","kind":"trial","name":"RC48 Combined With Chemotherapy in HER2-Positive Advanced Breast Cancer Patients With Prior TOP1i-ADC Failure","route":"/trials/nct07366840/"},{"id":"nct06771622","kind":"trial","name":"Safety and Efficacy of HCB101 in Combination With Multiple Agents in Patients With Advanced Solid Tumors","route":"/trials/nct06771622/"},{"id":"nct06245356","kind":"trial","name":"Safety of Trifluridine/Tipiracil in Patients With Dihydropyrimidine Dehydrogenase Deficiency Diagnosed With Metastatic Colorectal or Gastroesophageal Cancer","route":"/trials/nct06245356/"},{"id":"safir-abc10","kind":"trial","name":"SAFIR-ABC10","route":"/trials/safir-abc10/"},{"id":"nct00615602","kind":"trial","name":"Six vs 12 Months of Trastuzumab With Docetaxel Following FEC as Adjuvant Treatment in N+ Breast Cancer","route":"/trials/nct00615602/"},{"id":"nct04208178","kind":"trial","name":"Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation","route":"/trials/nct04208178/"},{"id":"nct05417594","kind":"trial","name":"Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies","route":"/trials/nct05417594/"},{"id":"nct06686394","kind":"trial","name":"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)","route":"/trials/nct06686394/"},{"id":"nct06731478","kind":"trial","name":"Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer","route":"/trials/nct06731478/"},{"id":"nct05725200","kind":"trial","name":"Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer","route":"/trials/nct05725200/"},{"id":"nct03262935","kind":"trial","name":"SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer","route":"/trials/nct03262935/"},{"id":"tapur","kind":"trial","name":"TAPUR (Targeted Agent and Profiling Utilization Registry)","route":"/trials/tapur/"},{"id":"nct06490536","kind":"trial","name":"The Sagittarius Trial","route":"/trials/nct06490536/"},{"id":"nct06589830","kind":"trial","name":"TL938 and Trastuzumab for Patients With HER2-positive Metastatic Colorectal Cancer","route":"/trials/nct06589830/"},{"id":"toga","kind":"trial","name":"ToGA","route":"/trials/toga/"},{"id":"nct07047365","kind":"trial","name":"TQB2930 Injection for the Treatment of HER2-positive Advanced Breast Cancer","route":"/trials/nct07047365/"},{"id":"train-2","kind":"trial","name":"TRAIN-2","route":"/trials/train-2/"},{"id":"trap-btc","kind":"trial","name":"TRAP-BTC","route":"/trials/trap-btc/"},{"id":"nct07506057","kind":"trial","name":"Trastuzumab in Combination With Serplulimab and Chemotherapy for the Treatment of HER2-overexpressing Unresectable Locally Advanced or Metastatic Biliary Tract Cancer or Urothelial Carcinoma After Failure of Standard Therapy","route":"/trials/nct07506057/"},{"id":"nct07062263","kind":"trial","name":"Trastuzumab Plus Chemotherapy vs Chemotherapy Alone in First-line HER2 Positive Advanced Biliary Tract Cancer Patients","route":"/trials/nct07062263/"},{"id":"nct07129018","kind":"trial","name":"Trastuzumab Rezetecan Combined With Pertuzumab and Iparomlimab and Tuvonralimab for Biliary Tract Cancer","route":"/trials/nct07129018/"},{"id":"nct03379428","kind":"trial","name":"Trial of Ibrutinib Plus Trastuzumab in HER2-amplified Metastatic Breast Cancer","route":"/trials/nct03379428/"},{"id":"triumph","kind":"trial","name":"TRIUMPH","route":"/trials/triumph/"},{"id":"nct04430738","kind":"trial","name":"Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers","route":"/trials/nct04430738/"},{"id":"nct05458674","kind":"trial","name":"Tucatinib+Trastuzumab+Eribulin in HER2+ MBC","route":"/trials/nct05458674/"}],"paper":[{"id":"paper-bertotti-xenopatients-her2-cetuximab-resistant-colorectal-cancer-discov-2011","kind":"paper","name":"A molecularly annotated platform of patient-derived xenografts identifies HER2 as an effective therapeutic target in cetuximab-resistant colorectal cancer","route":"/key-papers/paper-bertotti-xenopatients-her2-cetuximab-resistant-colorectal-cancer-discov-2011/"},{"id":"paper-aphinity-nejm-2017","kind":"paper","name":"APHINITY: adjuvant pertuzumab added to trastuzumab and chemotherapy in early HER2-positive breast cancer","route":"/key-papers/paper-aphinity-nejm-2017/"},{"id":"paper-apt-tolaney-nejm-2015","kind":"paper","name":"APT: adjuvant paclitaxel and trastuzumab for small, node-negative HER2-positive breast cancer","route":"/key-papers/paper-apt-tolaney-nejm-2015/"},{"id":"paper-valtorta-her2-scoring-colorectal-heracles-mod-pathol-2015","kind":"paper","name":"Assessment of a HER2 scoring system for colorectal cancer: results from a validation study","route":"/key-papers/paper-valtorta-her2-scoring-colorectal-heracles-mod-pathol-2015/"},{"id":"paper-fader-trastuzumab-uterine-serous-jco-2018","kind":"paper","name":"Carboplatin-paclitaxel with or without trastuzumab in HER2-positive advanced or recurrent uterine serous carcinoma","route":"/key-papers/paper-fader-trastuzumab-uterine-serous-jco-2018/"},{"id":"paper-nakamura-triumph-ctdna-pertuzumab-trastuzumab-her2-colorectal-nat-med-2021","kind":"paper","name":"Circulating tumor DNA-guided treatment with pertuzumab plus trastuzumab for HER2-amplified metastatic colorectal cancer: a phase 2 trial (TRIUMPH)","route":"/key-papers/paper-nakamura-triumph-ctdna-pertuzumab-trastuzumab-her2-colorectal-nat-med-2021/"},{"id":"paper-destiny-gastric01-nejm-2020","kind":"paper","name":"DESTINY-Gastric01: trastuzumab deruxtecan in previously treated HER2-positive gastric cancer","route":"/key-papers/paper-destiny-gastric01-nejm-2020/"},{"id":"paper-destiny-lung01-nejm-2022","kind":"paper","name":"DESTINY-Lung01: trastuzumab deruxtecan in HER2-mutant non-small-cell lung cancer","route":"/key-papers/paper-destiny-lung01-nejm-2022/"},{"id":"paper-destiny-lung02-goto-jco-2023","kind":"paper","name":"DESTINY-Lung02: two doses of trastuzumab deruxtecan in HER2-mutant metastatic non-small-cell lung cancer","route":"/key-papers/paper-destiny-lung02-goto-jco-2023/"},{"id":"paper-destiny-pantumor02-jco-2024","kind":"paper","name":"DESTINY-PanTumor02: trastuzumab deruxtecan in HER2-expressing solid tumours","route":"/key-papers/paper-destiny-pantumor02-jco-2024/"},{"id":"paper-sartore-bianchi-heracles-trastuzumab-lapatinib-lancet-oncol-2016","kind":"paper","name":"Dual-targeted therapy with trastuzumab and lapatinib in treatment-refractory, KRAS codon 12/13 wild-type, HER2-positive metastatic colorectal cancer (HERACLES)","route":"/key-papers/paper-sartore-bianchi-heracles-trastuzumab-lapatinib-lancet-oncol-2016/"},{"id":"paper-her2climb-brain-lin-jco-2020","kind":"paper","name":"HER2CLIMB brain metastases analysis: intracranial efficacy and survival with tucatinib","route":"/key-papers/paper-her2climb-brain-lin-jco-2020/"},{"id":"paper-her2climb-nejm-2020","kind":"paper","name":"HER2CLIMB: tucatinib with trastuzumab and capecitabine for HER2-positive metastatic breast cancer, including brain metastases","route":"/key-papers/paper-her2climb-nejm-2020/"},{"id":"paper-katherine-nejm-2019","kind":"paper","name":"KATHERINE: switching to T-DM1 when HER2-positive breast cancer survives pre-surgery treatment","route":"/key-papers/paper-katherine-nejm-2019/"},{"id":"paper-keynote-811-janjigian-lancet-2023","kind":"paper","name":"KEYNOTE-811: pembrolizumab plus trastuzumab and chemotherapy for HER2-positive gastric or gastro-oesophageal junction adenocarcinoma","route":"/key-papers/paper-keynote-811-janjigian-lancet-2023/"},{"id":"paper-javle-mypathway-her2-biliary-lancet-oncol-2021","kind":"paper","name":"Pertuzumab and trastuzumab for HER2-positive, metastatic biliary tract cancer (MyPathway): a multicentre, open-label, phase 2a, multiple basket study","route":"/key-papers/paper-javle-mypathway-her2-biliary-lancet-oncol-2021/"},{"id":"paper-takahashi-trastuzumab-docetaxel-salivary-duct-jco-2019","kind":"paper","name":"Phase 2 trial of trastuzumab and docetaxel in HER2-positive salivary duct carcinoma","route":"/key-papers/paper-takahashi-trastuzumab-docetaxel-salivary-duct-jco-2019/"},{"id":"paper-slamon-trastuzumab-nejm-2001","kind":"paper","name":"Slamon 2001: adding trastuzumab to chemotherapy for HER2-positive metastatic breast cancer","route":"/key-papers/paper-slamon-trastuzumab-nejm-2001/"},{"id":"paper-halassy-self-experiment-ovt-vaccines-2024","kind":"paper","name":"The self-experiment: a virologist treated her own recurrent breast cancer with two viruses she made in her own laboratory","route":"/key-papers/paper-halassy-self-experiment-ovt-vaccines-2024/"},{"id":"paper-toga-trastuzumab-gastric-lancet-2010","kind":"paper","name":"ToGA (Bang 2010): trastuzumab with chemotherapy for HER2-positive advanced gastric cancer","route":"/key-papers/paper-toga-trastuzumab-gastric-lancet-2010/"},{"id":"paper-siena-destiny-crc01-trastuzumab-deruxtecan-lancet-oncol-2021","kind":"paper","name":"Trastuzumab deruxtecan (DS-8201) in patients with HER2-expressing metastatic colorectal cancer (DESTINY-CRC01)","route":"/key-papers/paper-siena-destiny-crc01-trastuzumab-deruxtecan-lancet-oncol-2021/"},{"id":"paper-strickler-mountaineer-tucatinib-trastuzumab-lancet-oncol-2023","kind":"paper","name":"Tucatinib plus trastuzumab for chemotherapy-refractory, HER2-positive, RAS wild-type unresectable or metastatic colorectal cancer (MOUNTAINEER)","route":"/key-papers/paper-strickler-mountaineer-tucatinib-trastuzumab-lancet-oncol-2023/"},{"id":"paper-tuxedo-1-trastuzumab-deruxtecan-brain-metastases-nat-med-2022","kind":"paper","name":"TUXEDO-1: trastuzumab deruxtecan in HER2-positive breast cancer with active brain metastases","route":"/key-papers/paper-tuxedo-1-trastuzumab-deruxtecan-brain-metastases-nat-med-2022/"}],"term":[{"id":"amplification","kind":"term","name":"Amplification","route":"/terms/amplification/"},{"id":"antibody","kind":"term","name":"Antibody","route":"/terms/antibody/"},{"id":"bpcia","kind":"term","name":"Biologics Price Competition and Innovation Act 2010","route":"/terms/bpcia/"},{"id":"biosimilar","kind":"term","name":"Biosimilar","route":"/terms/biosimilar/"},{"id":"cardiotoxicity","kind":"term","name":"Cardiotoxicity (LVEF decline, cardiomyopathy)","route":"/terms/cardiotoxicity/"},{"id":"dual-her2-blockade","kind":"term","name":"Dual HER2 blockade","route":"/terms/dual-her2-blockade/"},{"id":"epitope","kind":"term","name":"Epitope","route":"/terms/epitope/"},{"id":"her2-positive","kind":"term","name":"HER2-positive (IHC 3+ or ISH-amplified)","route":"/terms/her2-positive/"},{"id":"somatic-mutation-theory","kind":"term","name":"Somatic mutation theory of cancer","route":"/terms/somatic-mutation-theory/"},{"id":"trastuzumab-cardiotoxicity","kind":"term","name":"Trastuzumab cardiotoxicity","route":"/terms/trastuzumab-cardiotoxicity/"},{"id":"who-essential-medicines","kind":"term","name":"WHO Essential Medicines List for cancer","route":"/terms/who-essential-medicines/"}],"idea":[{"id":"idea-tr1-public-de-escalation-trial-fund","kind":"idea","name":"A public fund for trials that test less treatment","route":"/ideas/idea-tr1-public-de-escalation-trial-fund/"},{"id":"idea-acc-risk-stratified-cardio-oncology-pathway","kind":"idea","name":"A risk-stratified cardio-oncology pathway for everyone receiving heart-toxic cancer therapy","route":"/ideas/idea-acc-risk-stratified-cardio-oncology-pathway/"},{"id":"idea-fund-abbreviated-pathway-me-too-biologics","kind":"idea","name":"An abbreviated approval path for follow-on antibodies within a validated class","route":"/ideas/idea-fund-abbreviated-pathway-me-too-biologics/"},{"id":"idea-reg-biosimilar-no-efficacy-trial","kind":"idea","name":"Approve cancer biosimilars on analytics and pharmacokinetics, no efficacy trials","route":"/ideas/idea-reg-biosimilar-no-efficacy-trial/"},{"id":"idea-moon-cardioprotection-by-default","kind":"idea","name":"Biomarker-guided cardioprotection for everyone on cardiotoxic cancer therapy","route":"/ideas/idea-moon-cardioprotection-by-default/"},{"id":"idea-reg-biosimilar-first-default-switching","kind":"idea","name":"Biosimilar-first defaults and payment parity in every cancer day unit","route":"/ideas/idea-reg-biosimilar-first-default-switching/"},{"id":"idea-tdxd-first-then-nothing","kind":"idea","name":"Can T-DXd alone cure early HER2-positive disease?","route":"/ideas/idea-tdxd-first-then-nothing/"},{"id":"idea-cost-shorter-course-trials","kind":"idea","name":"Fund trials that test shorter courses of the most expensive adjuvant drugs","route":"/ideas/idea-cost-shorter-course-trials/"},{"id":"idea-her2-adc-serous-endometrial","kind":"idea","name":"HER2 ADCs as standard for HER2-positive serous endometrial cancer","route":"/ideas/idea-her2-adc-serous-endometrial/"},{"id":"idea-tr1-home-infusion-trial-drugs","kind":"idea","name":"Home infusion and local blood draws for trial drugs after the first cycles","route":"/ideas/idea-tr1-home-infusion-trial-drugs/"},{"id":"idea-cost-biosimilar-default-substitution","kind":"idea","name":"Make the biosimilar the default at the pharmacy for trastuzumab, bevacizumab and rituximab","route":"/ideas/idea-cost-biosimilar-default-substitution/"},{"id":"idea-reg-pooled-procurement-adult-essentials","kind":"idea","name":"Pooled international procurement of essential adult cancer medicines","route":"/ideas/idea-reg-pooled-procurement-adult-essentials/"},{"id":"idea-moon-pooled-procurement-licensing-pool","kind":"idea","name":"Pooled procurement and voluntary licensing for essential cancer medicines in low-income countries","route":"/ideas/idea-moon-pooled-procurement-licensing-pool/"},{"id":"idea-acc-eml-listing-price-commitments","kind":"idea","name":"Tie WHO essential-medicines listing to a published tiered price and supply pledge","route":"/ideas/idea-acc-eml-listing-price-commitments/"},{"id":"idea-acc-biosimilar-prequalification-pool","kind":"idea","name":"WHO prequalification plus pooled demand to push biosimilar prices below 10% of the originator","route":"/ideas/idea-acc-biosimilar-prequalification-pool/"}],"institution":[{"id":"cdsco","kind":"institution","name":"Central Drugs Standard Control Organization","route":"/institutions/cdsco/"},{"id":"georgetown-lombardi","kind":"institution","name":"Georgetown Lombardi Comprehensive Cancer Center","route":"/institutions/georgetown-lombardi/"},{"id":"hospital-del-mar","kind":"institution","name":"Hospital del Mar / Hospital del Mar Research Institute","route":"/institutions/hospital-del-mar/"},{"id":"institut-jules-bordet","kind":"institution","name":"Institut Jules Bordet","route":"/institutions/institut-jules-bordet/"},{"id":"instituto-alexander-fleming","kind":"institution","name":"Instituto Alexander Fleming","route":"/institutions/instituto-alexander-fleming/"},{"id":"san-raffaele","kind":"institution","name":"IRCCS Ospedale San Raffaele","route":"/institutions/san-raffaele/"},{"id":"candiolo","kind":"institution","name":"Istituto di Candiolo IRCCS (FPO)","route":"/institutions/candiolo/"},{"id":"iov-veneto","kind":"institution","name":"Istituto Oncologico Veneto IRCCS","route":"/institutions/iov-veneto/"},{"id":"ucla-jonsson","kind":"institution","name":"UCLA Jonsson Comprehensive Cancer Center","route":"/institutions/ucla-jonsson/"}],"person":[{"id":"andrew-wardley","kind":"person","name":"Andrew Wardley","route":"/people/andrew-wardley/"},{"id":"barbara-bradfield","kind":"person","name":"Barbara Bradfield","route":"/people/barbara-bradfield/"},{"id":"dennis-slamon","kind":"person","name":"Dennis J. Slamon","route":"/people/dennis-slamon/"},{"id":"helena-earl","kind":"person","name":"Helena Earl","route":"/people/helena-earl/"},{"id":"martine-piccart","kind":"person","name":"Martine Piccart","route":"/people/martine-piccart/"},{"id":"sandra-swain","kind":"person","name":"Sandra M. Swain","route":"/people/sandra-swain/"},{"id":"sara-tolaney","kind":"person","name":"Sara M. Tolaney","route":"/people/sara-tolaney/"},{"id":"yelena-janjigian","kind":"person","name":"Yelena Y. Janjigian","route":"/people/yelena-janjigian/"},{"id":"bang-yung-jue","kind":"person","name":"Yung-Jue Bang","route":"/people/bang-yung-jue/"}],"bottleneck":[{"id":"b-dose-optimisation","kind":"bottleneck","name":"Wrong doses","route":"/bottlenecks/b-dose-optimisation/"}],"pathway":[{"id":"breast-cancer-signalling","kind":"pathway","name":"Breast cancer (KEGG map)","route":"/pathways/breast-cancer-signalling/"},{"id":"oncogene-activation-two-hit","kind":"pathway","name":"Drivers, passengers & the two-hit model","route":"/pathways/oncogene-activation-two-hit/"},{"id":"endometrial-cancer-signalling","kind":"pathway","name":"Endometrial cancer (KEGG map)","route":"/pathways/endometrial-cancer-signalling/"},{"id":"gastric-cancer-signalling","kind":"pathway","name":"Gastric cancer (KEGG map)","route":"/pathways/gastric-cancer-signalling/"},{"id":"nk-cell-recognition","kind":"pathway","name":"NK-cell recognition: missing self & stress ligands","route":"/pathways/nk-cell-recognition/"},{"id":"rtk-activation","kind":"pathway","name":"Receptor tyrosine kinase activation","route":"/pathways/rtk-activation/"}],"drug":[{"id":"her2-testing-assays","kind":"drug","name":"HER2 IHC and ISH companion assays (HercepTest, PATHWAY 4B5, HER2 Dual ISH)","route":"/drugs/her2-testing-assays/"}],"roadmap":[{"id":"targeted-therapy-roadmap","kind":"roadmap","name":"Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall","route":"/roadmaps/targeted-therapy-roadmap/"}]}}