OnCo
drugsProductApproved1998🇪🇺🇬🇧🇯🇵🇨🇳🇦🇺

Trastuzumab

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.

Metastatic (1998) and adjuvant (2006; HERA, NSABP B-31/N9831 with ~37% reduction in death). With pertuzumab (CLEOPATRA, APHINITY) as dual blockade; subcutaneous Phesgo. Backbone of T-DM1 and T-DXd antibodies. Biosimilars since 2017.

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Trastuzumab Fab bound to HER2 extracellular domain (PDB 1N8Z), backbone trace
RCSB PDB
Mechanism, step by step
auto-advancing · hover to pause

1.Antibody binds domain IV of HER2

Modality
Monoclonal antibody (anti-HER2)
Mechanism
Humanised IgG1 binding HER2 ECD4; signal inhibition and ADCC.
Brand / code
Herceptin (and biosimilars, Phesgo with pertuzumab)
Dosing & schedule
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
Dose modifications
Hold for LVEF drop ≥16 points or below normal
Monitoring
LVEF at baseline and every 3 months during therapy; infusion reactions

Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.

Medicare
Part B (clinician-administered)

Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. HCPCS J9355 for Herceptin; each biosimilar has its own Q-code. Under the Inflation Reduction Act, Part B coinsurance on a biosimilar is calculated on the reference product's price, so biosimilars usually cost the patient less.

Commercial insurance
step therapy common

Most commercial plans and PBM medical-benefit programmes now require a preferred trastuzumab biosimilar (e.g. Kanjinti, Ogivri, Trazimera) before the originator; prior authorisation confirms HER2 status.

Assistance programmes

20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.

Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B) · FDA: Biosimilars. Not medical or financial advice; verify with your plan.

NICE recommendedNICE TA34 · 2002SMC: accepted
Appraised for
HER2-positive advanced breast cancer
Notes
Adjuvant early breast cancer: TA107 (2006). HER2-positive gastric cancer: TA208 (2010). Biosimilars and the subcutaneous form are used under the same guidance and have cut the NHS price substantially.
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA34 · SMC advice: trastuzumab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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  1. 25 Sept 1998ApprovalUS

    HER2+ metastatic breast cancer: first targeted antibody for a solid tumour source

  2. 16 Nov 2006ApprovalUS

    Adjuvant HER2+ early breast cancer (HERA, NSABP B-31/N9831) source

  3. 20 Oct 2010ApprovalUS

    HER2+ metastatic gastric cancer (ToGA) source

  4. 1 Dec 2017ApprovalUS

    First trastuzumab biosimilar (Ogivri) source

  5. 28 Feb 2019ApprovalUS

    Subcutaneous trastuzumab-hyaluronidase (Herceptin Hylecta) source

  6. 29 Jun 2020ApprovalUS

    Phesgo (pertuzumab, trastuzumab, hyaluronidase) subcutaneous source

Approvals

RegionYearIndication
US1998HER2+ metastatic breast cancer
US2006Adjuvant HER2+ breast cancer
US2010HER2+ gastric cancer

Safety

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Toxicity profile
Adverse event
Cardiomyopathy / LVEF decline
Infusion reactions
Fever
Nausea
Diarrhoea
Pulmonary toxicity (rare)

Adjuvant trials: ~2-4% symptomatic heart failure with anthracyclines. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.

Cost & access

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Cost & access
CountryReimbursement
United StatesgenericMedicare Part B; five biosimilars available since 2019, roughly 15-35% below reference price
United KingdomNICE: standard of care; biosimilars widely used

List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
1211 studies17 recruiting84 Phase 216 Phase 3
Search “Trastuzumab” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Trastuzumab
intervention: Trastuzumab
Open on ClinicalTrials.gov →

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Key papers

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Latest papers

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Literature trend1,387 papers in the last 12 months+9% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Trastuzumab" OR ABSTRACT:"Trastuzumab" OR TITLE:"Herceptin" OR ABSTRACT:"Herceptin" OR TITLE:"and biosimilars" OR ABSTRACT:"and biosimilars" OR TITLE:"Phesgo with pertuzumab" OR ABSTRACT:"Phesgo with pertuzumab") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Trastuzumab, not a curated reading list.

Connected

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Pages like this

not linked directly; found by shared links

cancers

6

technologies

1

targets

1

companies

1

institutions

13

pathways

3

terms

9

trials

12

pairings

3

ideas

13

people

7

bottlenecks

1

key papers

1