Drug · Monoclonal Antibody

Trastuzumab

CI-DRUG-00000605Explore in graph →NCIt C1647 CHEMBL1201585 CIViC Approved

Regulatory

Approvals (47)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

emaRegulatory11 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
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

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 17 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	175	78	171	758	47	CA, EU, US	Sep 25, 1998	1998-04
Malignant Breast Neoplasm	Approved	Phase 4	96	37	109	488	4	EU, US	Sep 25, 1998	1998-04
Malignant Gastric Neoplasm	Phase4	Phase 4	23	10	13	62	0	—	—	2001-11
Malignant Esophageal Neoplasm	Phase3	Phase 3	7	4	4	17

Curated evidence

Clinical evidence (127)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 101–127 of 127 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 Mutation + ERBB3 MutationERBB3 ERBB21

Clinical trials

Trials with this intervention (795)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 51–100 of 795 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
NCT05408845	Testing the Use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) or Trastuzumab Deruxtecan for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers	recruiting	Phase 2	146	NRG OncologyOTHER	1	Aug 17, 2026	clinicaltrials
NCT07766772	Trastuzumab Rezetecan Followed by Pyrotinib, and Trastuzumab Combined With Capecitabine as First-line Treatment for Advanced HER2-positive Breast Cancer

Molecule

Record

Kind: Monoclonal Antibody
Mechanism: Receptor protein-tyrosine kinase erbB-2 inhibitor
Targets: 1 gene
UNII: P188ANX8CK
Aliases: 4D5V8, ABP 980, ABP980, Abp-980 (trastuzumab biosimilar), ADHEROZA, ALT02, Anti-c-ERB-2, Anti-c-erbB2 Monoclonal Antibody, Anti-ERB-2, Anti-erbB-2, Anti-erbB2 Monoclonal Antibody, Anti-HER2/c-erbB2 Monoclonal Antibody, Anti-p185-HER2, Biceltis, Bmab-200, Canhera, CANMab, C-erb-2 Monoclonal Antibody, CT-P06, CT-P6, Dazublys, Dmb-3111, DMB-3111 (TRASTUZUMAB BIOSIMILAR), EG-12014, EG12014, Eg12014 trastuzumab biosimilar, Eg-12014 (trastuzumab biosimilar), HER2 Monoclonal Antibody, Herceptin, Herceptin Biosimilar PF-05280014 … (+65)

Data updated 20 hours agoSource updated unknown

Identifiers

Codes (49)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01FD01	TRASTUZUMAB
ATC (WHO)	L01FY01

ERBB2 Overexpression8
Lapatinib + TrastuzumabCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	submitted	EID7806 HER2 (ERBB2) overexpressing cell lines were generated by lentiviral transduction of HER2 into three colorectal carcinoma cell lines. Mouse xenografts of NCI-H508-HER2 cells were treated with single a… (full text at CIViC) PMID 26296355 · Leto et al., 2015 · Open in CIViC	civic
Trastuzumab + TucatinibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	A	Supports Sensitivity Response	3	submitted	EID11444 In a phase 2 trial (NCT03043313), the selective ERBB2 (HER2) small molecule inhibitor tucatinib in combination with the HER2 antibody trastuzumab yielded an overall response rate of 38% in HER2-posit… (full text at CIViC) PMID 37142372 · Strickler et al., 2023 · Open in CIViC	civic
Trastuzumab	Malignant Gastric Neoplasm	Predictive	B	Supports Sensitivity Response	3	submitted	EID7063 In a retrospective study of Chinese patients with advanced HER2 positive gastric or gastro-esophageal junction (GEJ) cancer who had progressed on first line trastuzumab, continuation (n = 19) versus … (full text at CIViC) Open in CIViC	civic
Capecitabine + TrastuzumabCombination	Malignant Pancreatic Neoplasm	Predictive	B	Does Not Support Sensitivity Response	4	accepted	EID5955 This is Phase II trial of Trastuzumab and capecitabine as first line treatment in patients with IHC 3+ HER2 expressing advanced pancreatic cancer or cancer with HER2 gene amplification of stage IVB. T… (full text at CIViC) PMID 22374460 · Harder et al., 2012 · Open in CIViC	civic
Gemcitabine + TrastuzumabCombination	Malignant Pancreatic Neoplasm	Predictive	B	Does Not Support Sensitivity Response	4	accepted	EID5956 Patients with metastatic pancreatic cancer with IHC 2+/3+ HER2 received gemcitabine and Trastuzumab combination. Screening logs demonstrated the rate of HER2 overexpression was 16%. Thirty-four patien… (full text at CIViC) PMID 15581051 · Safran et al., 2004 · Open in CIViC	civic
Docetaxel + TrastuzumabCombination	Malignant Salivary Gland NeoplasmALIAS	Predictive	B	Supports Sensitivity Response	4	submitted	EID7078 In this single-center, single-arm, open-label, phase II study, 57 patients with HER2-positive (as defined by 3+ IHC staining or evidence of amplification by FISH) salivary duct carcinoma were treated … (full text at CIViC) PMID 30452336 · Takahashi et al., 2019 · Open in CIViC	civic
Paclitaxel + TrastuzumabCombination	Malignant Salivary Gland NeoplasmALIAS	Predictive	C	Supports Sensitivity Response	2	accepted	EID6170 Case report of a 61-year-old caucasian male with a renal mass and subsequent liver metastases. Histopathological examination of the liver led to the diagnosis of metastastic adenocarcinoma of the sali… (full text at CIViC) PMID 23826550 · Firwana et al., 2012 · Open in CIViC	civic
Capecitabine + Trastuzumab + Zoledronic AcidCombination	Malignant Salivary Gland NeoplasmALIAS	Predictive	C	Supports Sensitivity Response	3	accepted	EID6171 Case report of a a 58 year old man with multiple bone metastases after local therapy of a carcinoma ex pleomorphic adenoma one year earlier. The original tumor tested strongly positive for HER2/neu by… (full text at CIViC) PMID 20504363 · Sharon et al., 2010 · Open in CIViC	civic

ERBB2 Amplification9
Trastuzumab	Malignant Endometrial NeoplasmCURATED_BROADER	Predictive	B	Does Not Support Sensitivity Response	2	accepted	EID1098 This phase II single arm study assessed trastuzumab monotherapy in HER2 positive endometrial cancers with tumor response as primary endpoint. Participants had stage III, IV or recurrent HER2 positive… (full text at CIViC) PMID 19840887 · Fleming et al., 2010 · Open in CIViC	civic
Chemotherapy + Pembrolizumab + TrastuzumabCombination	Malignant Gastric Neoplasm	Predictive	A	Supports Sensitivity Response	4	submitted	EID11251 In this randomized, double-blind, placebo-controlled, Phase III trial, 264 patients were enrolled with histologically or cytologically confirmed diagnoses of previously untreated, locally advanced, un… (full text at CIViC) PMID 34912120 · Janjigian et al., 2021 · Open in CIViC	civic
Trastuzumab	Malignant Gastric Neoplasm	Predictive	A	Supports Sensitivity Response	4	submitted	EID11253 In this open-label, randomized, phase II trial, 187 patients with HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma that had progressed while they were receiving at least two pre… (full text at CIViC) PMID 32469182 · Shitara et al., 2020 · Open in CIViC	civic
Pertuzumab + TrastuzumabCombination	Malignant NeoplasmALIAS	Predictive	B	Does Not Support Sensitivity Response	3	submitted	EID12025 In this phase 2 clinical trial, 35 patients harbouring tumours with HER2 amplifications (copy number (CN) ≥7) were treated with a combination of trastuzumab and pertuzumab. Patients with breast/gastro… (full text at CIViC) PMID 38433347 · Connolly et al., 2024 · Open in CIViC	civic
Pertuzumab + TrastuzumabCombination	Malignant Pancreatic Neoplasm	Predictive	B	Supports Sensitivity Response	2	accepted	EID5985 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. Two of nine … (full text at CIViC) PMID 29320312 · Hainsworth et al., 2018 · Open in CIViC	civic
〃	Malignant Uterine NeoplasmALIAS	Predictive	B	Does Not Support Sensitivity Response	2	accepted	EID5986 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. None of the … (full text at CIViC) PMID 29320312 · Hainsworth et al., 2018 · Open in CIViC	civic
Carboplatin + TrastuzumabCombination	Ovarian Mucinous Adenocarcinoma	Predictive	C	Supports Sensitivity Response	2	submitted	EID13137 Ovarian mucinous carcinoma responds poorly to paclitaxel and carboplatin, prompting interest in targeted therapy, and it resembles gastro-oesophageal adenocarcinoma, a tumour type in which HER2 (ERBB2… (full text at CIViC) PMID 20003286 · McAlpine et al., 2009 · Open in CIViC	civic
Pertuzumab + TrastuzumabCombination	Salivary Gland Carcinoma	Predictive	B	Supports Sensitivity Response	2	accepted	EID5984 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. Four of five… (full text at CIViC) PMID 29320312 · Hainsworth et al., 2018 · Open in CIViC	civic
Trastuzumab	Scrotal Paget DiseaseALIAS	Predictive	C	Supports Sensitivity Response	2	accepted	EID1693 A 71-year old male with metastatic extramammary Paget’s disease of the scrotum overexpressing Her2/neu was treated with trastuzumab, achieving a complete response. At 12 months, he maintains stable di… (full text at CIViC) PMID 25692060 · Barth et al., 2015 · Open in CIViC	civic