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 1–50 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
NCT07007559	ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer(ASPEN-09-03)	recruiting	Phase 2	120	ALX Oncology Inc.INDUSTRY	8	Sep 25, 2026	clinicaltrials
NCT00295893	Combination Chemotherapy With or Without Trastuzumab in Treating Patients With Stage II or Stage III Breast Cancer	active not recruiting	Phase 2	121	City of Hope Medical CenterOTHER	1	Sep 24, 2026	clinicaltrials
NCT03716180	DAPHNe: Paclitaxel/Trastuzumab/Pertuzumab in HER2-Positive BC	active not recruiting	Phase 1	100	Dana-Farber Cancer InstituteOTHER	1	Sep 24, 2026	clinicaltrials
NCT06452277	A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)(SOHO-02)	recruiting	Phase 3	555	BayerINDUSTRY	36	Sep 23, 2026	clinicaltrials
NCT04644068	Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies(PETRA)	active not recruiting	Phase 1 / Phase 2	702	AstraZenecaINDUSTRY	14	Sep 21, 2026	clinicaltrials
NCT07828054	Premedication With Dexamethasone for Preventing Interstitial Lung Disease in Patients With Breast Cancer Treated With Trastuzumab Deruxtecan(MARGARET)	not yet recruiting	Phase 3	244	Mario Negri Institute for Pharmacological ResearchOTHER	0	Sep 18, 2026	clinicaltrials
NCT07195695	Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations	recruiting	Phase 3	400	Boehringer IngelheimINDUSTRY	28	Sep 17, 2026	clinicaltrials
NCT06324357	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 With Different Types of HER2+ Cancer That Has Spread	recruiting	Phase 1 / Phase 2	768	Boehringer IngelheimINDUSTRY	10	Sep 16, 2026	clinicaltrials
NCT04721977	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)	active not recruiting	Phase 2	66	PfizerINDUSTRY	3	Sep 10, 2026	clinicaltrials
NCT06625775	Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors	recruiting	Phase 1	392	TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)INDUSTRY	6	Sep 9, 2026	clinicaltrials
NCT03006172	To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer	active not recruiting	Phase 1	200	Genentech, Inc.INDUSTRY	5	Sep 8, 2026	clinicaltrials
NCT04873362	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(Astefania)	active not recruiting	Phase 3	1,188	Hoffmann-La RocheINDUSTRY	32	Sep 3, 2026	clinicaltrials
NCT04886531	Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers	recruiting	Phase 2	30	Ruth O'ReganOTHER	1	Sep 3, 2026	clinicaltrials
NCT06649331	Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer	recruiting	Phase 2	160	Fudan UniversityOTHER	1	Sep 3, 2026	clinicaltrials
NCT07216105	FT836 With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors	recruiting	Phase 1	119	Fate TherapeuticsINDUSTRY	1	Sep 2, 2026	clinicaltrials
NCT07795424	Culmerciclib Combined With Letrozole and Dual HER2 Blockade as Neoadjuvant Therapy for HR+/HER2+ Breast Cancer	not yet recruiting	Phase 2	33	Shengjing HospitalOTHER	1	Aug 31, 2026	clinicaltrials
NCT02465060	Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)	active not recruiting	Phase 2	6,452	National Cancer Institute (NCI)NIH	3	Aug 28, 2026	clinicaltrials
NCT07102381	A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer(EmpowHER 208)	recruiting	Phase 2	125	Jazz PharmaceuticalsINDUSTRY	3	Aug 25, 2026	clinicaltrials
NCT04579380	Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations	active not recruiting	Phase 2	217	Seagen, a wholly owned subsidiary of PfizerINDUSTRY	8	Aug 21, 2026	clinicaltrials
NCT06441890	BRE-10: Biomarker Optimization of Neoadjuvant Therapy in Breast Cancer(BRE-10)	recruiting	Phase 2	28	University of Illinois at ChicagoOTHER	1	Aug 21, 2026	clinicaltrials
NCT04886804	Beamion LUNG-1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene)	active not recruiting	Phase 1	554	Boehringer IngelheimINDUSTRY	18	Aug 20, 2026	clinicaltrials
NCT04893109	ATEMPT 2.0: Adjuvant T-DM1 vs TH	recruiting	Phase 2	500	Dana-Farber Cancer InstituteOTHER	1	Aug 19, 2026	clinicaltrials
NCT07766772	Trastuzumab Rezetecan Followed by Pyrotinib, and Trastuzumab Combined With Capecitabine as First-line Treatment for Advanced HER2-positive Breast Cancer	not yet recruiting	Phase 2	50	Fujian Cancer HospitalOTHER_GOV	1	Aug 14, 2026	clinicaltrials
NCT01937117	Pertuzumab and Trastuzumab as Neoadjuvant Treatment in Patients With HER2-Positive Breast Cancer	active not recruiting	Phase 2	88	Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsOTHER	1	Aug 13, 2026	clinicaltrials
NCT05113251	Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer	active not recruiting	Phase 3	927	AstraZenecaINDUSTRY	18	Aug 11, 2026	clinicaltrials
NCT06439693	The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer	recruiting	Phase 2	72	Dana-Farber Cancer InstituteOTHER	1	Aug 6, 2026	clinicaltrials
NCT07683754	T-DXd Based Therapy Followed by Endocrine Therapy Plus Dual HER2 Blockade in First-line HER2+/ HR+ Metastatic Breast Cancer and Retreatment With T-DXd(DB-Guide)	not yet recruiting	Phase 3	200	Daiichi SankyoINDUSTRY	0	Jul 23, 2026	clinicaltrials
NCT07716046	Fulvestaciclib Combined With Anti-HER2 and Endocrine Therapy for HR+/HER2+ Advanced Breast Cancer(FACET)	not yet recruiting	Phase 2	240	Fudan UniversityOTHER	0	Jul 21, 2026	clinicaltrials
NCT03414658	The AVIATOR Study: Trastuzumab and Vinorelbine With Avelumab OR Avelumab & Utomilumab in Advanced HER2+ Breast Cancer	active not recruiting	Phase 2	100	Adrienne G. WaksOTHER	1	Jul 20, 2026	clinicaltrials
NCT04285671	Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer	active not recruiting	Phase 1 / Phase 2	30	Jonsson Comprehensive Cancer CenterOTHER	1	Jul 17, 2026	clinicaltrials
NCT07386938	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	active not recruiting	Phase 3	246	R-PharmINDUSTRY	1	Jul 14, 2026	clinicaltrials
NCT05458674	Tucatinib+Trastuzumab+Eribulin in HER2+ MBC	active not recruiting	Phase 2	17	Criterium, Inc.INDUSTRY	1	Jul 10, 2026	clinicaltrials
NCT07694986	Trial of Therapies With IT cDC1s Combined w/ IT Trastuzamab for Her+ or IT Nivolumab for Her- BC LMD	recruiting	Phase 2	30	H. Lee Moffitt Cancer Center and Research InstituteOTHER	1	Jul 10, 2026	clinicaltrials
NCT03747120	Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab [IIT2018-04-MCARTHUR-NEOHP]	active not recruiting	Phase 2	138	University of Texas Southwestern Medical CenterOTHER	1	Jul 8, 2026	clinicaltrials
NCT06239467	First-in-Human Study of OKI-219 in Advanced Solid Tumors and Advanced Breast Cancer(PIKture-01)	active not recruiting	Phase 1	200	OnKure, Inc.INDUSTRY	6	Jul 6, 2026	clinicaltrials
NCT05323955	Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib(BRIDGET)	active not recruiting	Phase 2	48	Carey Anders, M.D.OTHER	1	Jun 23, 2026	clinicaltrials
NCT04188548	A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer(EMBER)	active not recruiting	Phase 1	379	Eli Lilly and CompanyINDUSTRY	8	Jun 22, 2026	clinicaltrials
NCT04928261	Evaluating 6-months of HER2-targeted Therapy in Patients With HER2 Positive Early-stage Breast Cancer That Achieve a Pathological Complete Response to Neoadjuvant Systemic Therapy	active not recruiting	Phase 4	52	Ottawa Hospital Research InstituteOTHER	1	Jun 16, 2026	clinicaltrials
NCT07619066	A Phase II Study of Zongertinib Plus Fulvestrant in Participants With HR-positive/HER2-negative Advanced Breast Cancer Harboring HER2 Mutations.(AGATHA)	not yet recruiting	Phase 2	25	MedSIROTHER	0	Jun 1, 2026	clinicaltrials
NCT05582499	Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy(FASCINATE-N)	recruiting	Phase 2	716	Fudan UniversityOTHER	1	May 28, 2026	clinicaltrials
NCT06686394	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)	recruiting	Phase 1 / Phase 2	81	Merck Sharp & Dohme LLCINDUSTRY	6	May 22, 2026	clinicaltrials
NCT06663787	Personalized Detection of ctDNA for Patients With HER2-Positive Metastatic Breast Cancer Patients Who Achieved Durable Response to Anti-HER2 Treatment(HER2 CR)	active not recruiting	—	50	Nagoya City UniversityOTHER	2	May 13, 2026	clinicaltrials
NCT01042379	I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer(I-SPY)	recruiting	Phase 2	5,000	QuantumLeap Healthcare CollaborativeOTHER	1	May 6, 2026	clinicaltrials
NCT07220135	Trial of Neoadjuvant THP vs TCHP for HER2-Amplified/Positive Breast Cancer(NeoTHERa)	recruiting	Phase 2	100	University of Kansas Medical CenterOTHER	1	May 6, 2026	clinicaltrials
NCT06589830	TL938 and Trastuzumab for Patients With HER2-positive Metastatic Colorectal Cancer	recruiting	Phase 2	80	Suzhou Teligene Ltd.INDUSTRY	1	Apr 28, 2026	clinicaltrials
NCT03820141	Durvalumab With Trastuzumab and Pertuzumab in HER2-Enriched Breast Cancer(DTP)	active not recruiting	Phase 2	51	The Methodist Hospital Research InstituteOTHER	1	Apr 20, 2026	clinicaltrials
NCT02326974	T-DM1+Pertuzumab in Pre-OP Early-Stage HER2+ BRCA	active not recruiting	Phase 2	164	Dana-Farber Cancer InstituteOTHER	1	Apr 17, 2026	clinicaltrials
NCT07527806	Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET/CT Molecular Imaging	not yet recruiting	Phase 2	156	Peking University Cancer Hospital & InstituteOTHER	0	Apr 17, 2026	clinicaltrials
NCT03377387	Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer	active not recruiting	Phase 1 / Phase 2	34	Memorial Sloan Kettering Cancer CenterOTHER	1	Apr 16, 2026	clinicaltrials
NCT07528898	Neoadjuvant SHR-A1811 Combined With Pertuzumab in HER2-Positive Breast Cancer: An Exploratory Clinical Study.	not yet recruiting	Phase 2	100	Hebei Medical University Fourth HospitalOTHER	1	Apr 14, 2026	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)