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.

openfdaRegulatory19 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2024-06-18 (see label)	approved	Jun 18, 2024	openfda
US FDA	—	Efficacy supplement 2019-05-16 (see label)	approved	May 16, 2019	openfda
US FDA	—	Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product ( 1 , 2.2 ).	approved	Jan 18, 2019	openfda
US FDA	Malignant Breast Neoplasm	The treatment of HER2-overexpressing breast cancer.	approved	Jan 18, 2019	openfda

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 13 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 1–50 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 Amplification26
Pertuzumab + Trastuzumab

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 16 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 L755S1

Fluorouracil + Leucovorin + TrastuzumabCombination

Colorectal Adenocarcinoma

Predictive

Does Not Support Sensitivity Response

accepted

EID4955

Patient was a 35 year old male who was treated with pseudoadjuvant FOLFOX chemotherapy. Patient relapsed and was found to have an ERBB2 L755S kinase domain mutation along with mutations in APC and BRA… (full text at CIViC)

PMID 27626067 · Aung et al., 2016 · Open in CIViC

ERBB2 Overexpression2
Carboplatin + Paclitaxel + TrastuzumabCombination	Endometrial Serous Adenocarcinoma	Predictive	B	Supports Sensitivity Response	4	submitted	EID7386 In a randomized phase 2 trial, patients who have uterine serous carcinoma that overexpress erbb2 were allocated carboplatin-paclitaxed with or without trastuzumab. Median progression-free survival was… (full text at CIViC) PMID 29584549 · Fader et al., 2018 · Open in CIViC	civic
Trastuzumab	Gastroesophageal Junction Adenocarcinoma	Predictive	B	Supports Sensitivity Response	3	submitted	EID7062 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

PIK3CA Amplification2
Dactolisib + TrastuzumabCombination	HER2-Positive Breast CarcinomaALIAS	Predictive	D	Supports Sensitivity Response	2	submitted	EID8272 In a preclinical study, efficacy of NVP-BEZ235 (dactolisib) and trastuzumab combination therapy was evaluated in vitro against HER2 amplified breast cancer cell line BT474 with retrovirally induced PI… (full text at CIViC) PMID 19010894 · Eichhorn et al., 2008 · Open in CIViC	civic
Dactolisib + Lapatinib + TrastuzumabCombination	HER2-Positive Breast CarcinomaALIAS	Predictive	D	Supports Sensitivity Response	2	submitted	EID8273 In a preclinical study, efficacy of NVP-BEZ235 (dactolisib), lapatinib, and trastuzumab combination therapy was evaluated in vitro against HER2 amplified breast cancer cell line BT474 with retrovirall… (full text at CIViC) PMID 19010894 · Eichhorn et al., 2008 · Open in CIViC	civic

PIK3CA H1047R5
Capivasertib + TrastuzumabCombination	HER2-Positive Breast CarcinomaALIAS	Predictive	D	Supports Sensitivity Response	3	accepted	EID1505 Tumor xenografts in mice were established with the KPL4 HER2 positive breast cancer cell line with PIK3CA H1047R mutation. KPL4 has suboptimal responses to trastuzumab and lapatinib. Xengraft treatmen… (full text at CIViC) PMID 22294718 · Davies et al., 2012 · Open in CIViC	civic
Dactolisib + TrastuzumabCombination	HER2-Positive Breast CarcinomaALIAS	Predictive	D	Supports Sensitivity Response	2	submitted	EID8182 In a preclinical study, efficacy of trastuzumab and NVP-BEZ235 (dactolisib) combination therapy was evaluated in vitro against HER2 amplified breast cancer cell line BT474 with retrovirally induced PI… (full text at CIViC) PMID 19010894 · Eichhorn et al., 2008 · Open in CIViC	civic
Lapatinib + TrastuzumabCombination	HER2-Positive Breast CarcinomaALIAS	Predictive	D	Supports Resistance	4	accepted	EID6204 In a preclinical study, efficacy of lapatinib and trastuzumab was evaluated in vitro against HER2 amplified breast cancer cell line BT474 (heterozygous for PIK3CA K111N) retrovirally transduced with P… (full text at CIViC) PMID 19010894 · Eichhorn et al., 2008 · Open in CIViC	civic
Trastuzumab	HER2-Positive Breast CarcinomaALIAS	Predictive	D	Supports Resistance	3	accepted	EID6203 This preclinical study tested the effect of trastuzumab (an anti-HER2 drug) on HER2-positive breast cancer cell lines (BT474 and SKBR3) retrovirally transduced with H1047R. The study found that the H1… (full text at CIViC) PMID 19010894 · Eichhorn et al., 2008 · Open in CIViC	civic
〃	HER2-Positive Breast CarcinomaALIAS	Predictive	D	Supports Resistance	2	accepted	EID8548 As part of a pre-clinical experiment, the efficacy of trastuzumab was evaluated against various HER2 positive cell lines. CC1954 and KPL-4 cell lines expressing PIK3CA H1047R were associated with resi… (full text at CIViC) PMID 26920887 · Baselga et al., 2016 · Open in CIViC	civic