HER2 (ERBB2) activating mutation — biomarker · CancerIndex

Biomarker · Gene alteration

HER2 (ERBB2) activating mutation

Activating ERBB2 (HER2) mutations, chiefly exon 20 insertions, detected by sequencing of tumor tissue or plasma; used as a predictive marker distinct from HER2 overexpression, notably in non-small cell lung cancer.

CI-BIO-00000004ERBB2 graph →NCIt C96866 Tumor-agnostic · 1 approval row

Also calledHER2 mutation · ERBB2 mutation · HER2 exon 20 insertion · HER2-mutant NSCLC

Tissue-agnostic indications

Approval rows flagged tumor-agnostic (1)

Trastuzumab Deruxtecan US FDA · Dec 20, 2019 · drug in derived setRegulatory approved

The flag is the source's (openFDA label text), never inferred; the full indication text of each row is in the Approvals section below.

Derived

Associated cancers (4)

Cancers mapped in ACCEPTED CIViC predictive, prognostic or diagnostic items whose variant (molecular markers) or gene (gene-level markers) is in this biomarker's scope. Counts by type and native level; each row links to the cancer's evidence tab.

Computedrule biomarker-links-v1

Cancer	Items	Predictive	Prognostic	Diagnostic	Levels A / B / C / D / E
Lung Non-Small Cell Carcinoma	6	6	—	—	4 / 2 / 0 / 0 / 0
Bladder Carcinoma	1	1	—	—	0 / 0 / 1 / 0 / 0
Malignant Breast Neoplasm	1

Derived

Drugs with predictive evidence (7)

Therapies named in in-scope PREDICTIVE CIViC items, plus targets of PREDICTS_RESPONSE_TO knowledge edges from in-scope variants. Sensitivity and resistance are counted separately and never merged into a verdict.

Computedrule biomarker-links-v1

Drug	CIViC items	Sensitivity	Resistance	Best level	Edges (S / R)	Cancer context
Trastuzumab DeruxtecanAdc	3	3	—	A	3 / 0	Lung Non-Small Cell Carcinoma
PertuzumabMonoclonal Antibody	2	2	—	B	1 / 0	Lung Non-Small Cell Carcinoma, Malignant Colorectal Neoplasm
TrastuzumabMonoclonal Antibody	2	2	—	B	1 / 0	Lung Non-Small Cell Carcinoma, Malignant Colorectal Neoplasm
NeratinibSmall Molecule	1	1	—	B	1 / 0	Malignant Breast Neoplasm
Platinum Compound	1	1	—	C	1 / 0	Bladder Carcinoma
SevabertinibSmall Molecule	1	1	—	A	1 / 0	Lung Non-Small Cell Carcinoma
ZongertinibSmall Molecule	1	1	—	A	1 / 0	Lung Non-Small Cell Carcinoma

Curatedcivic items and knowledge edges as curated at the source.

Curated evidence

Predictive evidence items (9)

ACCEPTED CIViC predictive items in scope, grouped by molecular profile and therapy with native level, direction and cancer context. 50 per page.

civicCuratedShowing 1–9 of 9 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
ERBB2 Mutation5
Platinum Compound	Bladder Carcinoma	Predictive	C	Supports Sensitivity Response	3	accepted	EID1694 In patients with muscle-invasive bladder chancer, a cohort of complete responders to platinum chemotherapy (n=38) and non-responders to platinum chemotherapy (n=33) were evaluated for 178 cancer-assoc… (full text at CIViC) PMID 25636205 · Groenendijk et al., 2016 · Open in CIViC	civic
Trastuzumab Deruxtecan	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	4	accepted	EID11731 In a phase 2 trial, 152 previously-treated metastatic NSCLC patients harboring mutations in ERBB2 (HER2) were treated with 2 different doses of the HER2 ADC trastuzumab deruxtecan (5.4 mg/kg and 6.4 m… (full text at CIViC) PMID 37694347 · Goto et al., 2023 · Open in CIViC	civic
Pertuzumab + TrastuzumabCombination	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	2	accepted	EID5980 The phase 2a MyPathway study assigned patients with HER2, EGFR, BRAF or SHH alterations to treatment with pertuzumab plus trastuzumab, erlotinib, vemurafenib, or vismodegib, respectively. Among thirty… (full text at CIViC) PMID 29320312 · Hainsworth et al., 2018 · Open in CIViC	civic
Zongertinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	4	accepted	EID12530 The authors report evaluation of zongertinib in a multicohort, phase 1a/1b trial involving patients with advanced or metastatic HER2-mutant non-small cell lung cancer. Three cohorts of patients are re… (full text at CIViC) PMID 40293180 · Heymach et al., 2025 · Open in CIViC	civic
Neratinib	Malignant Breast Neoplasm	Predictive	B	Supports Sensitivity Response	4	accepted	EID5338 16 patients with HER2-mutated metastatic breast cancer were treated with neratinib monotherapy. Of these 16 patients, 14 had known-activating mutations and 2 had mutations of unknown significance. Fiv… (full text at CIViC) PMID 28679771 · Ma et al., 2017 · Open in CIViC	civic
ERBB2 Exon 20 Insertion + ERBB2 Kinase Domain Mutation1
Sevabertinib	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	2	accepted	EID12808 In an open-label, multicenter, multicohort phase 1–2 study of non-small cell lung carcinoma (NCT05099172; total n = 209), single-agent sevabertinib 20 mg BID demonstrated clinically meaningful activit… (full text at CIViC) PMID 41104928 · Le et al., 2025 · Open in CIViC	civic
ERBB2 Exon 20 Insertion2
Trastuzumab Deruxtecan	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	4	accepted	EID11765 In a phase 2 trial, 152 metastatic NSCLC patients harboring mutations in ERBB2 (HER2) treated with 2 different doses of the HER2 ADC trastuzumab deruxtecan (5.4 mg/kg and 6.4 mg/kg) resulted in clinic… (full text at CIViC) PMID 37694347 · Goto et al., 2023 · Open in CIViC	civic
〃	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	5	accepted	EID10140 In a phase 2 trial, 91 patients with ERBB2-mutant metastatic non-small-cell lung cancer, refractory to standard treatment, were treated with trastuzumab deruxtecan. The objective response was 55% (95%… (full text at CIViC) PMID 34534430 · Li et al., 2022 · Open in CIViC	civic
ERBB2 Mutation + ERBB3 MutationERBB3 ERBB21
Pertuzumab + TrastuzumabCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Does Not Support Sensitivity Response	3	accepted	EID11669 In this clinical study of 38 patients with colorectal cancer (CRC), 10 had CRC with ERBB2/ERBB3 mutation, and were treated with a combination of Pertuzumab and Trastuzumab. A DC of 10% and OR of 0% we… (full text at CIViC) PMID 36315917 · Gupta et al., 2022 · Open in CIViC	civic

Regulatory

Approvals mentioning the linked drugs (100)

Approval records of the derived drug set, plus records whose indication text names this biomarker. Each record names its authority, jurisdiction, indication text and status — a drug approved in one jurisdiction for one indication is not 'approved' in general, and an approval listed here is not necessarily restricted to this biomarker.

Computedrule biomarker-links-v1

openfdaRegulatory50 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Trastuzumab Deruxtecan	US FDA	Tumor-agnostic	HER2-Positive Locally Advanced or Metastatic Gastric Cancer as monotherapy for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH positive) gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. • HER2-Positive (IHC 3+) Unresectable or Metastatic Solid Tumors as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options* • * These indications are approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ( 14.3 , 14.5 )accelerated	approved	Dec 20, 2019	openfda
Neratinib	CA Health Canada	—	Marketed in Canada as NERLYNX (DIN 02490536) under ATC L01EH02 NERATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 20, 2019	health-canada-dpd
Neratinib

1 record matched on indication text only (drug not in the derived set). Health Canada DIN rows carry no indication text and only match by drug.

Clinical trials

Active trials (102)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 40 recruiting · 18 active phase 3 · 521 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 51–100 of 102 active studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT04686305	Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC(DL03)	recruiting	Phase 1	304	AstraZenecaINDUSTRY	19	Apr 13, 2026	clinicaltrials
NCT07371585	Trastuzumab Deruxtecan in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management(TOP-REAL)	recruiting	Phase 2	300	SOLTI Breast Cancer Research GroupOTHER	3	Mar 27, 2026	clinicaltrials
NCT07335081	ctDNA in HER2+ EBC Neoadjuvant Treatment	recruiting	Phase 2	60	Shanghai Jiao Tong University School of MedicineOTHER	1	Mar 24, 2026	clinicaltrials
NCT07421141	De-escalation of Neoadjuvant Treatment (Paclitaxel + HP) in Early HER2+ Breast Cancer(Opti-HER2)	active not recruiting	Phase 2	186	National Medical Research Radiological Centre of the Ministry of Health of RussiaOTHER	1	Feb 27, 2026	clinicaltrials
NCT07193394	Tucatinib and Trastuzumab in HER3-mutant and HER2-not Amplified Metastatic Breast Cancer(H3RAKLES)	recruiting	Phase 2	20	Institut CurieOTHER	1	Feb 23, 2026	clinicaltrials
NCT07417241	SHR-A1811 vs Pyrotinib/Capecitabine in Trastuzumab-Resistant HER2+ Advanced Breast Cancer: A Randomized Study	not yet recruiting	Phase 2	100	Peking University Cancer Hospital & InstituteOTHER	0	Feb 18, 2026	clinicaltrials
NCT06348134	Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery	recruiting	Phase 2	74	University of ChicagoOTHER	1	Feb 17, 2026	clinicaltrials
NCT02226276	Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer	active not recruiting	N/A	10	City of Hope Medical CenterOTHER	1	Feb 13, 2026	clinicaltrials
NCT07366840	RC48 Combined With Chemotherapy in HER2-Positive Advanced Breast Cancer Patients With Prior TOP1i-ADC Failure(BRIGHT)	not yet recruiting	Phase 2 / Phase 3	268	Fudan UniversityOTHER	0	Jan 26, 2026	clinicaltrials
NCT03368729	Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer	active not recruiting	Phase 1 / Phase 2	46	University of Alabama at BirminghamOTHER	1	Jan 23, 2026	clinicaltrials
NCT03879577	Assessing the Response Rate of Neo-adjuvant Taxotere and Trastuzumab in Nigerian Women With Breast Cancer	active not recruiting	Phase 2	53	University of ChicagoOTHER	1	Jan 21, 2026	clinicaltrials
NCT05933395	Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor(GERTRUDE)	recruiting	Phase 2	135	Dartmouth-Hitchcock Medical CenterOTHER	1	Jan 20, 2026	clinicaltrials
NCT04290793	Neoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ Breast Cancer	active not recruiting	Phase 2 / Phase 3	113	Hebei Medical University Fourth HospitalOTHER	1	Jan 7, 2026	clinicaltrials
NCT06245356	Safety of Trifluridine/Tipiracil in Patients With Dihydropyrimidine Dehydrogenase Deficiency Diagnosed With Metastatic Colorectal or Gastroesophageal Cancer(TRIFLUOX-DP)	recruiting	Phase 2	73	UNICANCEROTHER	1	Dec 10, 2025	clinicaltrials
NCT04538742	A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer(DB-07)	active not recruiting	Phase 1 / Phase 2	245	AstraZenecaINDUSTRY	15	Dec 8, 2025	clinicaltrials
NCT07246317	Evaluation of Neoadjuvant Therapy With Trastuzumab, Pertuzumab, Docetaxel, and QL1706 in Early or Locally Advanced HER2+ Breast Cancer	not yet recruiting	Phase 2	188	Tianjin Medical University Cancer Institute and HospitalOTHER	1	Nov 28, 2025	clinicaltrials
NCT04193059	Study Comparing EC-T Verses PCb in the Adjuvant Chemotherapy of Non-triple Negative Breast Cancer(PANSY)	active not recruiting	Phase 3	1,560	Fudan UniversityOTHER	1	Nov 26, 2025	clinicaltrials
NCT04514419	Treatment of Breast Cancer With Trastuzumab + HS627/ Pertuzumab + Docetaxel	active not recruiting	Phase 3	408	BioRay Pharmaceutical Co., Ltd.INDUSTRY	1	Nov 21, 2025	clinicaltrials
NCT06328738	ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer	active not recruiting	Phase 1	275	Enliven TherapeuticsINDUSTRY	7	Nov 19, 2025	clinicaltrials
NCT04425018	MARGetuximab Or Trastuzumab (MARGOT)(MARGOT)	active not recruiting	Phase 2	174	Dana-Farber Cancer InstituteOTHER	1	Nov 18, 2025	clinicaltrials
NCT02827877	Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer	active not recruiting	Phase 2	18	City of Hope Medical CenterOTHER	1	Nov 14, 2025	clinicaltrials
NCT06008275	Neratinib in Combination With Ruxolitinib in Patients With mTNBC	recruiting	Early Phase 1	20	Baylor Research InstituteOTHER	1	Nov 10, 2025	clinicaltrials
NCT06178159	DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer	recruiting	Phase 2	40	RemeGen Co., Ltd.INDUSTRY	1	Oct 1, 2025	clinicaltrials
NCT07187752	Identification of HER2-Positive Breast Cancer Molecular Characterization and Subtypes	not yet recruiting	N/A	1,039	Shandong Cancer Hospital and InstituteOTHER	0	Sep 23, 2025	clinicaltrials
NCT05063786	Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET)(ALPHABET)	active not recruiting	Phase 3	27	Spanish Breast Cancer Research GroupOTHER	6	Sep 8, 2025	clinicaltrials
NCT05900206	Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer(ARIADNE)	recruiting	Phase 2	370	Karolinska University HospitalOTHER	1	Sep 2, 2025	clinicaltrials
NCT07134153	Phase I/II Study of Intrathecal/Ommaya T-DXd in HER2-Expressing Breast Cancer With Leptomeningeal/Brain Metastases(INOVATE)	recruiting	Phase 1 / Phase 2	139	Fudan UniversityOTHER	1	Aug 21, 2025	clinicaltrials
NCT07093931	Efficacy and Safety of Lobaplatin and Carboplatin as Neoadjuvant Therapy in HER-2 Positive Breast Cancer	not yet recruiting	Phase 4	468	Shandong Cancer Hospital and InstituteOTHER	1	Jul 30, 2025	clinicaltrials
NCT05802225	Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer(PREFER)	active not recruiting	Phase 3	398	BiocadINDUSTRY	1	Jul 20, 2025	clinicaltrials
NCT07047755	Trastuzumab Rezetecan Plus Pertuzumab in the Neoadjuvant Treatment of HER2 Positive BC	not yet recruiting	Phase 2	48	Henan Cancer HospitalOTHER_GOV	0	Jul 2, 2025	clinicaltrials
NCT05346224	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	active not recruiting	Phase 3	900	Shanghai Henlius BiotechINDUSTRY	4	Jun 10, 2025	clinicaltrials
NCT03161353	Chemotherapy-free Trastuzumab and Pertuzumab in HER2-positive Breast Cancer: FDG-PET Response-adapted Strategy.(PHERGain)	active not recruiting	Phase 2	377	MedSIROTHER	7	Apr 23, 2025	clinicaltrials
NCT04680442	Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction(SCHOLAR-2)	recruiting	Phase 2	130	Population Health Research InstituteOTHER	3	Apr 6, 2025	clinicaltrials
NCT00999804	Extension Study of Lapatinib Plus Herceptin With or Without Endocrine Therapy(HELEX)	active not recruiting	Phase 2	128	Baylor Breast Care CenterOTHER	1	Mar 12, 2025	clinicaltrials
NCT05020860	Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer(RESPONSE)	recruiting	Phase 2	185	Baylor Breast Care CenterOTHER	1	Feb 27, 2025	clinicaltrials
NCT02625441	Adjuvant Trastuzumab, Pertuzumab Plus Docetaxel in the Treatment of Early HER2-positive Breast Cancer(BOLD-1)	active not recruiting	Phase 3	516	Helsinki University Central HospitalOTHER	1	Feb 11, 2025	clinicaltrials
NCT05388149	Kadcyla And Neratinib for Interception of HER2+ Breast Cancer With Molecular Residual Disease	recruiting	Phase 2	15	University Health Network, TorontoOTHER	1	Jan 31, 2025	clinicaltrials
NCT03379428	Trial of Ibrutinib Plus Trastuzumab in HER2-amplified Metastatic Breast Cancer	active not recruiting	Phase 1 / Phase 2	34	US Oncology ResearchINDUSTRY	1	Dec 6, 2024	clinicaltrials
NCT05891561	Short-course Trastuzumab, Pertuzumab with Taxanes in the Adjuvant Treatment of Early HER2-positive Breast Cancer	recruiting	Phase 2	120	Shanghai Jiao Tong University School of MedicineOTHER	1	Nov 27, 2024	clinicaltrials
NCT06510465	Neoadjuvant Therapy With Weekly Utidelone Combined With Cisplatin for Patients With Breast Cancer (NeoURANIA)(NeoURANIA)	not yet recruiting	Phase 2	143	RenJi HospitalOTHER	1	Jul 19, 2024	clinicaltrials
NCT06217185	The Efficacy and Safety of Pyrotinib, Trastuzumab Combined With Taxanes in the Treatment of Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).	recruiting	Phase 4	100	Hebei Medical University Fourth HospitalOTHER	1	Feb 28, 2024	clinicaltrials
NCT05159193	Neoadjuvant Treatment Pegylated Liposomal Doxorubicin Plus Cyclophosphamide Sequential Docetaxel Plus Trastuzumab and Pertuzumab Versus Docetaxel Plus Carboplatin Combined With Trastuzumab and Pertuzumab in HER-2 Positive Breast Cancer	recruiting	Phase 3	372	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityOTHER	1	Feb 2, 2024	clinicaltrials
NCT06162559	Neoadjuvant Trastuzumab, Pertuzumab and Tucatinib Without Chemotherapy in HER2-positive Breast Cancer: the TRAIN-4 Study(TRAIN-4)	recruiting	Phase 1	30	The Netherlands Cancer InstituteOTHER	1	Jan 11, 2024	clinicaltrials
NCT04172259	ACHP-THP vs EC-THP as Neoadjuvant Therapy for HER2-positive EBC	active not recruiting	Phase 2	156	Sun Yat-sen UniversityOTHER	1	Oct 16, 2023	clinicaltrials
NCT05983094	Study of Utidelone Based Neoadjuvant Treatment on Early High-risk or Locally Advanced Breast Cancer	not yet recruiting	Phase 2	181	Cancer Institute and Hospital, Chinese Academy of Medical SciencesOTHER	1	Aug 9, 2023	clinicaltrials
NCT05841381	Adjuvant Study of Pyrotinib in Combination With Trastuzumab in HER2 Positive Invasive Breast Cancer	not yet recruiting	Phase 3	876	Fudan UniversityOTHER	0	May 3, 2023	clinicaltrials
NCT05638594	Pyrotinib Combined With Trastuzumab, Dalpiciclib, Letrozole Versus TCbHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HR +/HER2 + Breast Cancer	recruiting	Phase 2	236	Shengjing HospitalOTHER	1	Mar 20, 2023	clinicaltrials
NCT05725200	Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer(EVIDENT)	recruiting	Phase 2	40	Oslo University HospitalOTHER	1	Feb 21, 2023	clinicaltrials
NCT05420454	A Study for the Neoadjuvant Treatment of Breast Cancer	recruiting	Phase 4	1,576	Second Affiliated Hospital, Zhejiang University, School of MedicineOTHER	1	Jul 1, 2022	clinicaltrials
NCT05420467	A Study for the Adjuvant Treatment of Breast Cancer	recruiting	Phase 4	2,413	Second Affiliated Hospital, Zhejiang University, School of MedicineOTHER	1	Jul 1, 2022	clinicaltrials

A study listed here tests a linked drug in a linked cancer; it does not necessarily select participants on this biomarker.

Trastuzumab

EU EMA

—

Breast cancer Metastatic breast cancer Dazublys is indicated for the treatment of adult patients with HER2-positive metastatic breast cancer (MBC): as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor-positive patients must also have failed hormonal therapy unless patients are unsuitable for these treatments. in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor-positive MBC, not previously treated with trastuzumab. Early breast cancer Dazublys is indicated for the treatment of adult patients with HER2-positive early breast cancer. (EBC). following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1). following adjuvant chemotherapy with doxorubicin and cyclophosphamide in combination with paclitaxel or docetaxel. in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. in combination with neoadjuvant chemotherapy followed by adjuvant Dazublys therapy for locally advanced (including inflammatory) disease or tumors> 2 cm in diameter (see sections 4.4 and 5.1). Dazublys should only be used in patients with metastatic or early breast cancer whose tumors have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay (see sections 4.4 and 5.1). Metastatic gastric cancer Dazublys in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease. Dazublys should only be used in patients with metastatic gastric cancer (MGC) whose tumors have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result or by an IHC 3+ result. Accurate and validated assay methods should be used (see sections 4.4 and 5.1).

approved

Jun 30, 2025

ema

Trastuzumab

EU EMA

—

Metastatic breast cancer (MBC) For the treatment of adult patients with HER2-positive MBC: as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy unless patients are unsuitable for these treatments. in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab  Early breast cancer (EBC) For the treatment of adult patients with HER2-positive EBC: following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel. in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. in combination with neoadjuvant chemotherapy followed by adjuvant HD201 therapy, for locally advanced (including inflammatory) disease or tumours >2 cm in diameter.  HD201 should only be used in patients with MBC or EBC whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay. Metastatic gastric cancer (MGC) In combination with capecitabine or 5-fluorouracil and cisplatin for the treatment of adult patients with HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. HD201 should only be used in patients with MGC whose tumours have HER2 overexpression as defined by Immunohistochemistry (IHC) 2+ and a confirmatory silver-enhanced in situ hybridisation (SISH) or fluorescence in situ hybridisation (FISH) result, or by an IHC 3+ result. Accurate and validated assay methods should be used.

approved

Sep 19, 2024

ema

Approval rows flagged tumor-agnostic (1)

Associated cancers (4)

Drugs with predictive evidence (7)

Predictive evidence items (9)

Approvals mentioning the linked drugs (100)

Active trials (102)

Linked publications (8)