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Trastuzumab

  • Antibody medicine
  • Given by a clinician
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Trastuzumab does in the body

Trastuzumab is an antibody that grips that receptor from outside, stops it pairing with its partners, and flags the cell for destruction by immune cells.

One breast cancer in five has a growth receptor stuck in the on position, jammed there because the gene making it has been copied too many times. It only helps if the receptor is actually there, which is why the tumour has to be tested first.

Why people take it. Used for breast and stomach cancers driven by too much of one growth signal.

What happened in people

In 469 women with advanced breast cancer driven by that signal, half the combination group went 7.4 months before worsening, versus 4.6 with chemotherapy alone.

Reviewed first-read answer

Where this came from

A person wrote this and a reviewer approved it against this exact record. It carries no effect size.

A reviewer approved this against this record. The reviewed-claim record carrying the exact population and effect size does not exist yet.

No source is stored against this line.

The limit that matters most

Different tests and cutoffs can disagree about whether a tumour is suitable for treatment.

Where it acts
HER2-overexpressing tumour cell membrane
Kind of result
The kind of result is not recorded
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • The substance registry classes this as protein.

    FDA substance registry · P188ANX8CK · read 2026-08-29

Where each sentence above came from

A person wrote this explanation into the record, with the studies named in the path below.

A reviewer approved this sentence against this exact record and its sources.

The limit a reviewer approved as the one that matters most here.

The four opening statements run to 112 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Confidence interval

A confidence interval is the range the true answer is likely to sit in.

A picture of it, and where the picture fails

It is like a weather forecast giving a range rather than one number.

Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.

What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.

An interval estimate that would contain the true parameter in a stated proportion of repeated studies.

Enzyme

An enzyme is a protein that speeds up one chemical change.

A picture of it, and where the picture fails

An enzyme is like a machine on a production line doing one cut.

Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.

What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.

A catalytic protein that lowers the activation energy of a specific reaction.

Receptor

A receptor is a part of a cell that a signal fits into.

A picture of it, and where the picture fails

A receptor is like a lock waiting for one key.

Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.

What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.

A protein that binds a specific ligand and converts that binding into a cellular response.

Pathway

A pathway is a chain of steps inside a cell, each one setting off the next.

A picture of it, and where the picture fails

A pathway is like a row of dominoes.

Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.

What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.

An ordered series of molecular interactions producing a defined cellular change.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Results from the one trial this record names

  • In NCT00045032, Percentage of participants with a disease-free survival event (loco-regional or distant recurrence, contralateral breast cancer, a second non-breast malignancy, or death from any cause) in the Herceptin one-year arm compared with the observation arm: primary outcome was Herceptin one-year arm: 7.5% of participants against Observation arm: 12.9% of participants in the comparison group at From baseline until time of event (median of one year). The recorded difference is Hazard ratio 0.54 for the Herceptin arm versus the observation arm (95% CI 0.44 to 0.67; p<0.0001 (Log Rank)).

    ClinicalTrials.gov record · NCT00045032 · read 2026-08-28

Time to disease progression with first-line chemotherapy, with or without trastuzumab

The study showed what it set out to show

Who was studied
Slamon 2001 pivotal metastatic trial (H0648g, conducted before ClinicalTrials.gov registration)
How many people
469
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
p < 0.001
Repeated elsewhere
Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. Cardiac dysfunction was most frequent with concurrent anthracycline, cyclophosphamide and trastuzumab, and now carries a boxed warning.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Intravenous infusion, or subcutaneous injection co-formulated with recombinant hyaluronidase

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

Disease-free survival after adjuvant chemotherapy, one or two years of trastuzumab versus observation

The study showed what it set out to show

Who was studied
HERA (NCT00045032)
How many people
5099
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
p < 0.0001; HR 0.54 (95% CI 0.43-0.67) at first interim analysis
Repeated elsewhere
Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Intravenous infusion, or subcutaneous injection co-formulated with recombinant hyaluronidase

Interval reported. 95% CI 0

Written into the record, not signed off as a reviewed claim.

Four-year disease-free survival, 6 months versus 12 months of adjuvant trastuzumab, 3% non-inferiority margin

The study showed what it set out to show

Who was studied
PERSEPHONE (NCT00712140)
How many people
4088
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Non-inferiority p = 0.011; HR 1.07 (90% CI 0.93-1.24)
Repeated elsewhere
Partially Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Intravenous infusion, or subcutaneous injection co-formulated with recombinant hyaluronidase

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

What we know
RNAWiki holds 3 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What happened in peopleRead from sources, not yet reviewed

How close this is to real life

The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.

  1. Living longer, or avoiding a major event Evidence recorded. Death, a heart attack, a stroke, a hospital stay.10 registered measures of this kind. No reviewed result.
  2. What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  4. Symptoms and quality of life No evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
  5. A number that stands in for health No evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals Evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse. A result in animals says what to test next. It does not say what happens in people.
  8. Cells in a dish Evidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
  9. A guess from software No evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.

Higher on these steps means closer to something a person would feel. It does not mean better done.

What it changes in the bodyRead from sources, not yet reviewed

The path through the body

From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.

  1. Start

    Trastuzumab

    What a person takes: Intravenous infusion, or subcutaneous injection co-formulated with recombinant hyaluronidase.

    The measurement behind this step

    Lyophilised powder reconstituted for infusion, given as an 8 mg/kg load then 6 mg/kg every three weeks, or a fixed 600 mg subcutaneous dose over 2-5 minutes.

  2. Getting in

    Loading infusion and slow distribution

    A larger first dose is given over 90 minutes to fill the body, then smaller doses every one or three weeks keep the level steady.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    An 8 mg/kg loading dose followed by 6 mg/kg every three weeks, with a mean half-life near 28 days at steady state. A subcutaneous 600 mg fixed-dose formulation with recombinant hyaluronidase is also approved.

  3. Reaching the cell

    Finding the receptor-covered cells

    It circulates until it meets a cell whose surface is crowded with the HER2 receptor. Normal cells carry far fewer, so they are largely passed over.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    HER2-amplified cells display on the order of a million receptors per cell against tens of thousands on normal epithelium, so binding is driven by receptor density rather than by any tumour-specific antigen.

  4. What it acts on

    Binding subdomain IV of the extracellular region

    The antibody grips the outer part of the receptor closest to the cell membrane.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Binds juxtamembrane subdomain IV of the HER2 ectodomain. This is a different epitope from pertuzumab, which binds subdomain II and blocks heterodimerisation, which is why the two are additive rather than redundant.

  5. The change it makes

    Signalling shutdown plus immune recruitment

    Growth signalling inside the cell falls away, the shed fragment that would have kept signalling is prevented, and immune killer cells are called in to the coated cell.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Downregulates PI3K-AKT signalling, prevents proteolytic shedding of the ectodomain that would leave a constitutively active p95HER2 fragment, promotes receptor internalisation, and recruits natural killer cells through FcgammaRIIIa to drive antibody-dependent cellular cytotoxicity.

  6. What that does for a person

    Fewer recurrences years later

    In the metastatic setting the tumour is held back for longer. Given for a year after surgery, it measurably reduces the chance the cancer comes back at all.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Cell-cycle arrest through p27Kip1 stabilisation, reduced angiogenesis, and immune clearance of micrometastatic deposits combine to lower the recurrence hazard, an effect that persists for a decade in long-term HERA follow-up.

No suggested links are held for this record, so nothing is hidden from this path.

What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.

What it would be like to takeRead from sources, not yet reviewed

Felt, measured, or meaningful

Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.

Felt

Things a person could notice without a test.

No registered study measured anything of this kind.

Measured

Things only a test, a scale or a device shows.

No registered study measured anything of this kind.

Meaningful

Things that change how a life goes, not only a number.

  • disease free survival
  • disease free survival at 5 years
  • progression free survival
  • event free survival
  • achieved pathological complete remission
  • survival at 1 year
  • partial remission
  • 5 year overall survival rate
  • disease progression
  • overall survival exceeding 5 months in her2 positive disease

A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.

Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.

Measured, but not felt. A number moves. The person notices nothing. Both can be true.

Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.

Matters, but takes years. The result that counts may take longer than anyone would keep watching.

Names that fit none of the three (30)
  • response rate
  • cardiotoxicity
  • objective response rate as assessed by recist criteria
  • duration of dfs
  • time to progression
  • overall toxicity
  • frequency and duration of objective response
  • toxicity assessed using common toxicity criteria version 2 0
  • positive axillary lymph nodes
  • pathologic complete response rate in the breast and axilla
  • response rate by recist
  • overall response rate
  • at least one dose limiting toxicity in phase i
  • recommended phase ii dose
  • confirmed response rate
  • clinical benefit rate
  • dose limiting toxicities
  • overall response rates
  • acute treatment related toxicity
  • clinical response rate

These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • People whose tumour tests HER2-positive by immunohistochemistry 3+ or by in-situ hybridisation amplification, in the adjuvant, neoadjuvant or metastatic setting.

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

Who a named study recorded including and excluding

  • It included: Non-metastatic primary invasive breast cancer overexpressing HER2 (determined by immunohistochemistry 3+ or positive fluorescence in situ hybridization test) that has been histologically confirmed, adequately excised, axillary node positive or negative, and tumor size at least T1c according to Tumor/Node/Metastasis (TNM) staging; Completion of at least 4 cycles of (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable; Known hormone receptor status; Baseline left ventricular ejection fraction (LVEF) greater than or equal to 55 percent.

    ClinicalTrials.gov record · NCT00045032 · read 2026-08-28

  • It excluded: Prior invasive breast carcinoma; Other malignancies except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix; Clinical T4 tumors; Cumulative doxorubicin exposure greater than 360 milligrams per meter-squared, or epirubicin greater than 720 mg/m^2, or any prior anthracyclines unrelated to the present breast cancer; Prior anti-HER2 therapy for any other reason or other prior biologic or immunotherapy for breast cancer; Serious cardiac or pulmonary conditions/illness, or any other conditions that could interfere with planned treatment.

    ClinicalTrials.gov record · NCT00045032 · read 2026-08-28

What the label states about particular groups

  • On pediatric, the label states: “The safety and effectiveness of TRAZIMERA in pediatric patients have not been established.”

    US prescribing information · b9c5e894-27d2-4245-a653-df986fed3c56 · read 2026-08-30

  • On older people, the label states: “Trastuzumab has been administered to 386 patients who were 65 years of age or over (253 in the adjuvant treatment and 133 in metastatic breast cancer treatment settings).”

    US prescribing information · b9c5e894-27d2-4245-a653-df986fed3c56 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Trastuzumab products can cause fetal harm when administered to a pregnant woman.”

    US prescribing information · b9c5e894-27d2-4245-a653-df986fed3c56 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of trastuzumab products in human milk, the effects on the breastfed infant, or the effects on milk production.”

    US prescribing information · b9c5e894-27d2-4245-a653-df986fed3c56 · read 2026-08-30

Where the result stopped carrying

  • The murine parent antibody 4D5 was too immunogenic for repeated human use and had to be humanised onto a human IgG1 framework
  • Concurrent anthracycline and trastuzumab produced unacceptable cardiac dysfunction and that scheduling was abandoned
  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied for a different goal

The studies measured something else entirely.

On this record: Some registered studies measured things that match no goal on this page.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Given by a clinician

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Intravenous infusion, or subcutaneous injection co-formulated with recombinant hyaluronidase

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S1, S3, S4, S6.

No source is stored against this line.

What is in the pack

Lyophilised powder reconstituted for infusion, given as an 8 mg/kg load then 6 mg/kg every three weeks, or a fixed 600 mg subcutaneous dose over 2-5 minutes.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold and what that means for what is in the pack.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

The recorded stepping schedule

  • What follows is the schedule printed on the label, recorded as it is written there. It is a record of what was done, not a recommendation.

    US prescribing information · 492dbdb2-077e-4064-bff3-372d6af0a7a2 · read 2026-08-28

  • Initial dose, as a single agent within three weeks following completion of multi-modality, anthracycline-based chemotherapy regimens (adjuvant breast cancer): 8 mg/kg as an intravenous infusion over 90 minutes

    US prescribing information · 492dbdb2-077e-4064-bff3-372d6af0a7a2 · read 2026-08-28

  • Subsequent doses: 6 mg/kg as an intravenous infusion over 30–90 minutes every three weeks

    US prescribing information · 492dbdb2-077e-4064-bff3-372d6af0a7a2 · read 2026-08-28

What it would be like to takeRead from sources, not yet reviewed

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Worth asking a clinician aboutWritten into the record from the studies named on this page

Boxed warnings for cardiomyopathy, infusion reactions, embryo-fetal toxicity and pulmonary toxicity. Left ventricular ejection fraction must be measured before treatment and at intervals during it.

Nobody counted how many people took this and were fine, so this cannot be turned into a rate.

Where this came from

Reports sent to a regulator

  • These are reports people sent to a regulator. They do not show the medicine caused the reaction.
  • Nobody counted how many people took the medicine and reported nothing.
  • The same event can be reported more than once, and many reports are incomplete.
  • News coverage, lawsuits and new warnings change how often people report.
  • A count is not a rate and not a risk.

Trastuzumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 11838 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • diarrhoea — 3144 reaction mentions
  • disease progression — 1368 reaction mentions
  • ejection fraction decreased — 1161 reaction mentions
  • neutropenia — 1133 reaction mentions
  • myelosuppression — 990 reaction mentions
  • febrile neutropenia — 950 reaction mentions
  • neuropathy peripheral — 944 reaction mentions
  • chills — 821 reaction mentions
  • metastases to central nervous system — 698 reaction mentions
  • palmar-plantar erythrodysaesthesia syndrome — 629 reaction mentions
  • open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Intravenous infusion, or subcutaneous injection co-formulated with recombinant hyaluronidase

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 20 products list this as an active ingredient in the United States drug directory. 17 of them contain it and nothing else.

    FDA National Drug Code directory · 50242-077 · read 2026-08-29

  • They are sold as injection, injection, powder, lyophilized, for solution, injection, solution, liquid and solution, taken intravenous and subcutaneous.

    FDA National Drug Code directory · 50242-077 · read 2026-08-29

  • The regulator's established pharmacologic class for it is her2/neu/cerbb2 antagonists [moa] and her2/neu receptor antagonist [epc].

    FDA National Drug Code directory · 50242-077 · read 2026-08-29

  • 8 published labels name it as an active ingredient. 6 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 27dd5e6b-72cd-458d-a015-cf4dab5800da · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 27dd5e6b-72cd-458d-a015-cf4dab5800da · read 2026-08-29

  • Herceptin is for injection: lyophilized powder in a single-dose vial for reconstitution at For injection: 150 mg per single-dose vial, recorded as prescription product; fda label in effect 2026-05-29 in the United States.

    US prescribing information · 492dbdb2-077e-4064-bff3-372d6af0a7a2 · read 2026-08-28

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Trastuzumab studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

Claims that go past the evidence

Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.

Goes past the evidence

That twelve months is the optimal adjuvant duration; it was a design convention and PERSEPHONE found six months non-inferior

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That HER2-positive is an intrinsic binary property of a tumour rather than an assay result at a chosen threshold

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That two years would be better than one; HERA randomised that question and found no additional benefit

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

How fast does the body clear it?

The sources RNAWiki checked hold nothing for this field.

Why it matters. Without this, nothing on this page can say how long anything lasts.

What would answer it

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Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Formulation uncertainty

Several salts, forms or products of Trastuzumab are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Every line above can be traced to the study named beside it. Follow the link and read it.

Slamon 2001: adding trastuzumab to first-line chemotherapy in metastatic disease
In plain words
In 469 women with HER2-positive metastatic breast cancer, adding the antibody to chemotherapy lengthened the median time before the disease progressed from 4.6 to 7.4 months.
What was measured
Median time to progression 7.4 versus 4.6 months
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Randomised trial with 234 assigned to chemotherapy alone and 235 to chemotherapy plus trastuzumab. Median time to disease progression was 7.4 versus 4.6 months. Response rate, duration of response and overall survival all favoured the trastuzumab arm. The trial also produced the first clear cardiac safety signal.
Source
Slamon et al., New England Journal of Medicine 2001
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
HERA: one year of adjuvant trastuzumab halved early recurrence risk
In plain words
In over 5,000 women treated after surgery and chemotherapy, one year of the antibody reduced recurrence, second cancers and death by roughly half at the first planned analysis.
What was measured
Hazard ratio 0.54 (95% CI 0.43-0.67) for disease-free survival events at first analysis
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
International randomised trial, 1,694 assigned to one year of trastuzumab, 1,694 to two years and 1,693 to observation. At the first interim analysis with median follow-up of one year, 127 events occurred in the one-year trastuzumab group against 220 in the observation group; unadjusted hazard ratio 0.54 (95% CI 0.43-0.67). Longer follow-up showed the two-year arm gave no additional benefit over one year.
Source
Piccart-Gebhart et al., New England Journal of Medicine 2005 (HERA, NCT00045032)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
PERSEPHONE: six months was non-inferior to twelve, and the twelve-month standard was never derived from a dose-finding study
In plain words
The one-year duration was a pragmatic choice made when the first adjuvant trials were designed, not a measured optimum. A 4,088-patient trial later showed six months gave the same four-year disease-free survival with half the cardiac toxicity.
What was measured
4-year disease-free survival 89.4% (6 months) versus 89.8% (12 months), HR 1.07
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Open-label randomised non-inferiority trial in 152 UK centres, 2,045 assigned to 12 months and 2,044 to 6 months. Four-year disease-free survival was 89.4% for six months and 89.8% for twelve (hazard ratio 1.07, 90% CI 0.93-1.24, non-inferiority p = 0.011). Severe adverse events occurred in 19% versus 24%, and stopping early for cardiotoxicity in 3% versus 8%. Most guidelines still recommend twelve months, so this is a shift the evidence made that practice has only partly followed.
Source
Earl et al., The Lancet 2019 (PERSEPHONE, NCT00712140)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
Cardiac dysfunction is caused by the antibody, not only by the chemotherapy
In plain words
Giving trastuzumab at the same time as an anthracycline caused heart muscle weakening in a substantial minority of patients in the first metastatic trial. That result reshaped every regimen that followed.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
In Slamon 2001, cardiac dysfunction was most frequent in patients receiving an anthracycline, cyclophosphamide and trastuzumab concurrently. HER2 signalling is required for cardiomyocyte stress responses, so blockade impairs repair of anthracycline-mediated damage. Modern regimens sequence the anthracycline before trastuzumab or avoid it entirely, and serial left ventricular ejection fraction monitoring is mandated by the label.
Source
Slamon et al., NEJM 2001 and HERCEPTIN US Prescribing Information boxed warning
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
HER2-positive is treated as a fixed binary property of a tumour
In plain words
Whether a tumour counts as HER2-positive depends on which assay was run, on which sample, and on where the cut-off was drawn. Those cut-offs have moved, and the arrival of HER2-low as a treatable category shows the binary was always a convention.
What was measured
That HER2 status is an intrinsic binary property rather than an assay result at a chosen threshold
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
ASCO/CAP HER2 testing guidelines were revised in 2007, 2013 and 2018, each time reclassifying a fraction of tumours. Immunohistochemistry scoring is observer-dependent, intratumoural heterogeneity is common, and HER2 status can differ between primary and metastatic lesions. The approval of trastuzumab deruxtecan for HER2-low disease means tumours previously classified as HER2-negative now have a HER2-directed option, which the original binary framing cannot express.
Source
Successive ASCO/CAP HER2 testing guideline revisions and the HER2-low antibody-drug conjugate literature
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim

Where else this substance is registered

RxNorm concept
224905

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What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 1 approved application covers products containing this substance. The earliest was BLA103792, approved 19980925 to GENENTECH.

    Drugs@FDA application register · BLA103792 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · BLA103792 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20170210.

    FDA National Drug Code directory · 50242-077 · read 2026-08-29

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A humanised antibody against the HER2 receptor that lengthened median time to progression in metastatic disease from 4.6 to 7.4 months and, given for a year after surgery, produced a hazard ratio of 0.54 for recurrence or death at the first HERA analysis.

Recorded evidence blocks (13)

What did Trastuzumab's largest trial (35002 people) and its longest (40 years) measure?


35002 people in Trastuzumab's largest registered study, 40 years in its longest registered window, measuring Changes in Senescence and Secondary Biomarkers, Including TMEM, Mena, and 67LR. ClinicalTrials.gov · 2026-09-01

514 phase2, 191 phase1, 179 phase3, 37 na or unstated, 15 na, 12 phase4, 5 early phase1; NCT03390608; 2016-07-30. Last human test completed 2026, NCT05504720.

Interpretation These counts include studies where Trastuzumab was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.

Show the evidence
  • phase2
    514
  • phase1
    191
  • phase3
    179
  • na or unstated
    37
  • na
    15
  • phase4
    12
2 more recorded rows
  • early phase1
    5
  • Last recorded human test NCT05504720
    2026-08-05

recorded 2026-09-01 · last checked 2026-09-04

From mouse to human: where has Trastuzumab shown lifespan?


mouse: lifespan and human: biomarker (850): the rungs where Trastuzumab has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Changes in Senescence and Secondary Biomarkers, Including TMEM, Mena, and 67LR — the recorded outcome words.

Yeast C. elegans Drosophila Mouse lifespanRat Dog Non-human primate Human biomarker
Show the evidence
  • mouse
    lifespan
  • human NCT01897441
    biomarker; Changes in Senescence and Secondary Biomarkers, Including TMEM, Mena, and 67LR; 850

recorded 2026-09-01 · last checked 2026-09-04

121 of Trastuzumab's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, sponsor decision unspecified, other?


safety (9), futility/efficacy (5), accrual/recruitment (51), funding/business (11), sponsor decision unspecified (4) and other (41): Trastuzumab's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Trial is Life long follow-up: to reduce ressources and costs - trial terminated prematurely."; 121 of 850 registered studies

Show the evidence

Trial

  • NCT00004935
    terminated; "Trial is Life long follow-up: to reduce ressources and costs - trial terminated prematurely."
  • NCT00006015
    terminated; "lack of sufficient accrual"
  • NCT00006123
    withdrawn; "Never started"
  • NCT00016276
    terminated; "Administratively complete."
  • NCT00039455
    terminated; "Administratively complete."
  • NCT00041470
    terminated; "Sponsor withdrew the study"
14 further recorded trials
  • NCT00053339
    withdrawn; "The study was not activated."
  • NCT00057993
    withdrawn; "Unable to accrue subjects to the study after 2 years - closed per request by Data Monitoring Committee."
  • NCT00079326
    terminated; "Slow accrual."
  • NCT00088985
    terminated; "Funding unavailable"
  • NCT00118053
    terminated; "slow accrual"
  • NCT00126607
    terminated; "Poor accrual."
  • NCT00130507
    terminated; "A new alternative treatment caused the decrease in the rhythm of recruitment."
  • NCT00133796
    terminated; "Closed to accrual 4/19/2006 / Study doesn't qualify for reporting."
  • NCT00138125
    terminated; "Due to low accrual"
  • NCT00140140
    terminated; "Unable to determine the optimum tolerated dose"
  • NCT00169104
    terminated; "Closed due to achievement of primary study endpoint"
  • NCT00216047
    terminated; "Low patient enrollment; toxicities"
  • NCT00216073
    terminated; "Lack of patient accrual"
  • NCT00272987
    terminated; "Enrollment was closed after the open label stage due to poor recruitment rate (randomized stage never opened)."

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Trastuzumab used Trastuzumab (H, 8mg/kg — over how long?


studies of Trastuzumab used the recorded amount. ClinicalTrials.gov · 2026-09-01

6 recorded entries; human; also "Trastuzumab (H, 8mg/kg", "Herceptin-150 mg", "Herceptin-600 mg/5 mL"

Show the evidence

human

  • NCT02345772
    Trastuzumab (H, 8mg/kg
  • NCT03144947
    Herceptin-150 mg
  • NCT03144947
    Herceptin-600 mg/5 mL
  • NCT03203616
    KADCYLA 160 MG Injection
  • NCT04170595
    Herceptin,6 mg/kg
  • NCT04170595
    Herceptin:2mg/kg and Capecitabin:1000mg/kg

recorded 2026-09-01 · last checked 2026-09-04

Did Trastuzumab move epigenetic age, and by how much?


epigenetic age: "To examine the associations between pre-treatment epigenetic age acceleration, circulating leukocyte composition, and candidate single nucleotide polymorphisms (SNPs) with cardiotoxicity risk in breast cancer patients receiving trastuzumab." Europe PMC · epigenetic clock search · 2025-05-10

1 recorded sentence; 2025; biomarker

Show the evidence
  • epigenetic age PMID 40349094
    2025; "To examine the associations between pre-treatment epigenetic age acceleration, circulating leukocyte composition, and candidate single nucleotide polymorphisms (SNPs) with cardiotoxicity risk in breast cancer patients receiving trastuzumab."

recorded 2025-05-10 · last checked 2026-09-04

Which of 5 year overall survival rate, achieved pathological complete remission and acute treatment related toxicity did Trastuzumab's trials measure?


5 year overall survival rate, achieved pathological complete remission and acute treatment related toxicity lead 40 outcome terms across Trastuzumab's trials. ClinicalTrials.gov · 2026-09-01

objective response rate as assessed by recist criteria, duration of dfs, time to progression, overall toxicity, frequency and duration of objective response and toxicity assessed using common toxicity criteria version 2 0 follow.

Show the evidence
  • response rate
    1
  • disease free survival
    1
  • cardiotoxicity
    1
  • objective response rate as assessed by recist criteria
    1
  • duration of dfs
    1
  • time to progression
    1
14 more recorded rows
  • overall toxicity
    1
  • frequency and duration of objective response
    1
  • toxicity assessed using common toxicity criteria version 2 0
    1
  • positive axillary lymph nodes
    1
  • pathologic complete response rate in the breast and axilla
    1
  • disease free survival at 5 years
    1
  • progression free survival
    1
  • event free survival
    1
  • response rate by recist
    1
  • achieved pathological complete remission
    1
  • survival at 1 year
    1
  • overall response rate
    1
  • at least one dose limiting toxicity in phase i
    1
  • recommended phase ii dose
    1

recorded 2026-09-01 · last checked 2026-09-04

Which of Trastuzumab's 197 ongoing trials reports first?


197 registered trials of Trastuzumab are open; earliest completion 2025-01. ClinicalTrials.gov · 2026-09-01

Count of Patients With Pathologic Complete Response (pCR); Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs); latest 2040-12-31

Show the evidence

Trial

  • NCT00295893
    "Combination Chemotherapy With or Without Trastuzumab in Treating Patients With Stage II or Stage III Breast Cancer"; n 121; "Count of Patients With Pathologic Complete Response (pCR)"; 2026-08-11
  • NCT00781612
    "A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies"; n 378; "Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)"; 2027-06-30
  • NCT00999804
    "Extension Study of Lapatinib Plus Herceptin With or Without Endocrine Therapy"; n 128; "Pathologic Complete Response"; 2026-01
  • NCT01042379
    "I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer"; n 5000; "Determine whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry."; 2031-12
  • NCT01273610
    "Tolerability of the Combination of Lapatinib and Trastuzumab in Adults Age 60 or Older With HER2 Positive Locally Advanced or Metastatic Breast Cancer"; n 40; "Percent of Participants With Grade 3 or Higher Non-hematological Toxicities and Symptomatic Congestive Heart Failure"; 2027-04-20
  • NCT01785420
    "Pre Operative Trastuzumab in Operable Breast Cancer"; n 1100; "Disease Free Survival"; 2027-02
14 further recorded trials
  • NCT01937117
    "Pertuzumab and Trastuzumab as Neoadjuvant Treatment in Patients With HER2-Positive Breast Cancer"; n 88; "Percent Change in Standardized Uptake Value (SUV) as Measured by SULmax on [18F]Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)"; 2027-06
  • NCT02057133
    "A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread"; n 198; "Number of Participants with One or More Drug-Related Adverse Events"; 2026-12
  • NCT02226276
    "Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer"; n 10; "Relationship Between Average Tumor Uptake of Copper Cu 64-DOTA-trastuzumab as Measured by PET and Patient Best Response"; 2026-09-29
  • NCT02320435
    "A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial"; n 154; "Progression-Free Survival"; 2026-12-31
  • NCT02326974
    "T-DM1+Pertuzumab in Pre-OP Early-Stage HER2+ BRCA"; n 164; "Rate of Pathologic Complete Response (pCR) by HER2 Amplification Status Non-Heterogeneous"; 2028-01
  • NCT02436993
    "Phase II Breast Ca Carboplatin + Paclitaxel With Pertuzumab + Trastuzumab or Bevacizumab"; n 120; "2-year progression free survival in patients treated with weekly carboplatin and paclitaxel combined with either trastuzumab and pertuzumab for HER2-positive patients or bevacizumab for HER2-negative patients in the neoadjuvant setting"; 2036-12
  • NCT02465060
    "Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)"; n 6452; "Objective response rate (ORR)"; 2026-12-31
  • NCT02568839
    "Neoadjuvant Response-guided Treatment of HER2 Positive Breast Cancer"; n 202; "Pathological objective response to primary medical treatment"; 2029-02
  • NCT02625441
    "Adjuvant Trastuzumab, Pertuzumab Plus Docetaxel in the Treatment of Early HER2-positive Breast Cancer"; n 516; "Invasive disease-free survival"; 2025-06-01
  • NCT02678182
    "Planning Treatment for Oesophago-gastric Cancer: a Maintenance Therapy Trial"; n 494; "Progression Free Survival (PFS)"; 2027-06
  • NCT02827877
    "Cu64-DOTA-trastuzumab PET and Markers Predicting Response to Neoadjuvant Trastuzumab + Pertuzum in HER2+ Breast Cancer"; n 18; "Response to Neoadjuvant Chemotherapy Determined at Surgery (Lumpectomy or Mastectomy)."; 2026-09-25
  • NCT02947685
    "Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer"; n 518; "Progression-free Survival (PFS) as Assessed by Investigator"; 2026-07-31
  • 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"; n 200; "Stage 1: Percentage of Participants With Dose Limiting Toxicities"; 2026-12-31
  • NCT03125928
    "Clinical Trial of Atezolizumab With Paclitaxel, Trastuzumab, and Pertuzumab in Patients With Metastatic HER-2 Positive Breast Cancer"; n 16; "Number of participants with treatment-related adverse events"; 2027-12

recorded 2026-09-01 · last checked 2026-09-04

Which running trial of Trastuzumab could settle lifespan?


NCT02625441 measures Invasive disease-free survival, reading out 2025-06-01.

59 open trials; n 516; "Adjuvant Trastuzumab, Pertuzumab Plus Docetaxel in the Treatment of Early HER2-positive Breast Cancer"

Show the evidence

Trial

  • NCT02625441
    "Adjuvant Trastuzumab, Pertuzumab Plus Docetaxel in the Treatment of Early HER2-positive Breast Cancer"; n 516; "Invasive disease-free survival"; 2025-06-01
  • NCT05041842
    "Treatment With Tucatinib in Patients With an Isolated Brain Progression of a Metastatic Breast Cancer"; n 53; "Progression-Free Survival"; 2026-04-30
  • NCT05063786
    "Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET)"; n 27; "Progression Free Survival (PFS)"; 2026-06
  • NCT02947685
    "Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer"; n 518; "Progression-free Survival (PFS) as Assessed by Investigator"; 2026-07-31
  • NCT02320435
    "A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial"; n 154; "Progression-Free Survival"; 2026-12-31
  • NCT06439550
    "Adjuvant Treatment With Serplulimab,Trastuzumab and SOX in the HER-2 Positive GC/GEJC"; n 42; "Disease progression free survival (DFS)"; 2026-12-31
14 further recorded trials
  • NCT01785420
    "Pre Operative Trastuzumab in Operable Breast Cancer"; n 1100; "Disease Free Survival"; 2027-02
  • NCT03595592
    "Neoadjuvant Treatment of HER2 Positive Early High-risk and Locally Advanced Breast Cancer"; n 650; "Event Free Survival (EFS)"; 2027-03-15
  • NCT03414658
    "The AVIATOR Study: Trastuzumab and Vinorelbine With Avelumab OR Avelumab & Utomilumab in Advanced HER2+ Breast Cancer"; n 100; "Progression Free Survival"; 2027-05-31
  • NCT02678182
    "Planning Treatment for Oesophago-gastric Cancer: a Maintenance Therapy Trial"; n 494; "Progression Free Survival (PFS)"; 2027-06
  • NCT05800275
    "Capecitabine, Tucatinib, and Intrathecal Trastuzumab for Breast Cancer Patients With Leptomeningeal Disease"; n 30; "overall survival rate at 12 months"; 2027-06
  • NCT04193059
    "Study Comparing EC-T Verses PCb in the Adjuvant Chemotherapy of Non-triple Negative Breast Cancer"; n 1560; "disease free survival"; 2027-07
  • NCT04973319
    "Trastuzumab Combined With Pertuzumab for Adjuvant Treatment of Breast Cancer After Neoadjuvant Therapy"; n 450; "Invasive Disease-Free Survival (IDFS)"; 2027-08-01
  • NCT03587740
    "ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer"; n 111; "Invasive Disease-free Survival Rate (IDFS)"; 2027-08-30
  • NCT05132582
    "A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer"; n 654; "Progression-free survival (PFS) by investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1"; 2027-09-28
  • NCT05152147
    "A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers"; n 920; "Progression-free survival (PFS) by BICR"; 2027-09-30
  • NCT07407920
    "Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial"; n 120; "Event free survival (EFS)"; 2027-09-30
  • 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"; n 48; "Progression Free Survival (PFS)"; 2027-11
  • NCT06123338
    "A Study of Pembrolizumab With Trastuzumab and Chemotherapy in People With Esophagogastric Cancer"; n 49; "Event-free survival (EFS)"; 2027-11-30
  • NCT03803553
    "Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer"; n 400; "Disease-free survival (DFS)"; 2027-12

Which 174 trials of Trastuzumab posted no result?


Posted no result
174 of 174 completed trials
Registrations
NCT00005926, NCT00004163, NCT00004013, NCT00006108, NCT00003740 and NCT00005857, and 168 more
Completion dates
oldest 2000-12; newest 2024-08-27
Show the evidence

Trial

  • NCT00005926
    2000-12
  • NCT00004163
    2001-09
  • NCT00004013
    2001-10
  • NCT00006108
    2002-07
  • NCT00003740
    2002-09
  • NCT00005857
    2002-10
14 further recorded trials
  • NCT00003539
    2003-02
  • NCT00148681
    2003-05
  • NCT00031278
    2003-06
  • NCT00006104
    2003-07
  • NCT00004925
    2003-08
  • NCT00043394
    2003-10
  • NCT00006381
    2004-02
  • NCT00019812
    2004-02
  • NCT00003881
    2004-07
  • NCT00005033
    2004-08
  • NCT00016367
    2004-12-14
  • NCT00085020
    2005-02
  • NCT00146042
    2005-03
  • NCT00134680
    2005-07

At the median, Trastuzumab's trials enrolled 68 people — anything larger?


Median enrolment
68
Largest enrolment
35002
Registered trials counted
837

What do 11838 spontaneous reports say about Trastuzumab — and not say?


These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.

Trastuzumab appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 11838 reaction mentions were counted: diarrhoea 3144; disease progression 1368; ejection fraction decreased 1161; neutropenia 1133. open-targets-adr · CHEMBL1201585 · 2026-06-24

Show the evidence
  • diarrhoea
    3144
  • disease progression
    1368
  • ejection fraction decreased
    1161
  • neutropenia
    1133
  • myelosuppression
    990
  • febrile neutropenia
    950
4 more recorded rows
  • neuropathy peripheral
    944
  • chills
    821
  • metastases to central nervous system
    698
  • palmar-plantar erythrodysaesthesia syndrome
    629

recorded 2026-06-24 · last checked 2026-09-04

Was Trastuzumab studied with exercise?


exercise is named in Trastuzumab's label sentences: "Methods Patients were randomized to receive either adjuvant trastuzumab in combination with a training 12-week supervised exercise program in a training group (training group, TG) or trastuzumab alone (control group, CG)." openfda-label+europepmc · 2025-08-08

1 recorded statement; exercise

Show the evidence
  • exercise
    Methods Patients were randomized to receive either adjuvant trastuzumab in combination with a training 12-week supervised exercise program in a training group (training group, TG) or trastuzumab alone (control group, CG).

recorded 2025-08-08 · last checked 2026-09-04

What is recorded about Trastuzumab and mTOR?


"CD24 silencing modulates autophagy and induces apoptosis via Akt/mTOR inhibition, and its combination with trastuzumab exerts potent antitumor effects, offering a promising strategy for HER2 + breast cancer." — where Trastuzumab and mTOR appear together. Europe PMC · pathway abstract search · 2026-05-16

mTOR, autophagy, IGF-1; PMID 42141178, 40158191, 40426308, 40650051

Show the evidence
  • mTOR PMID 42141178
    "CD24 silencing modulates autophagy and induces apoptosis via Akt/mTOR inhibition, and its combination with trastuzumab exerts potent antitumor effects, offering a promising strategy for HER2 + breast cancer."
  • autophagy PMID 42141178
    "CD24 silencing modulates autophagy and induces apoptosis via Akt/mTOR inhibition, and its combination with trastuzumab exerts potent antitumor effects, offering a promising strategy for HER2 + breast cancer."

mTOR

  • PMID 40158191
    "Clinical trials investigating mTOR inhibitors like sirolimus and combination therapies with agents such as everolimus and trastuzumab are discussed, underscoring their potential in eradicating BCSCs and improving patient outcomes."
  • PMID 40426308
    "This study highlights the potential of combining Hh inhibitors with trastuzumab as a therapeutic strategy for HER2-positive GC by targeting the AKT/mTOR pathway."

autophagy

  • PMID 40650051
    "Here, we investigated how autophagy modulation affects trastuzumab-mediated ADCC in HER2-positive JIMT1 breast cancer cells and NK cells."
  • PMID 40696560
    "Autophagic flux protects HER2+ cancer cells from trastuzumab-induced cytotoxicity, so inhibiting it undermines the resistance phenotype."
  • IGF-1
    "The phosphatidylinositol 3′-kinase (PI3K)/protein kinase B (PKB)/mammalian target of rapamycin pathway (mTOR), cross-talk with estrogen receptors, over-expression of Mucin 1 (MUC1) protein, and involvement of tyrosine kinase receptors like insulin-like growth factor I receptor are key pathways involved in trastuzumab resistance (TR)."

recorded 2026-05-16 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1201585
CAS number
180288-69-1
RxCUI
224905
Development code
4D5V8, ABP 980, ABP980, EG-12014, EG12014, R-597, RHUMABHER2, RO-0452317, RO0452317, SYD-977, SYD977
Also called
Bmab-200, Canhera, Dmb-3111, Eg12014 trastuzumab biosimilar, Hercessi, Herzuma, Hlx 02, Hlx02, Hlx-02 trastuzumab biosimilar, Kanjinti, Ogivri, Ontruzant
Trade name
Herceptin, Herwenda, Kadcyla, Trastuzumab component of herceptin hylecta, Trastuzumab component of phesgo
International name
Trastuzumab beta
Sources (11)

Sources

  • ClinicalTrials.gov clinicaltrials.gov ·
  • ClinicalTrials.gov ClinicalTrials.gov API v2 snapshot 2026-09-01T09:00:05 ·
  • this record's own fields 2,3,5 ·
  • Europe PMC dose-response search ·
  • Europe PMC epigenetic clock search ·
  • Europe PMC pathway abstract search ·
5 more sources

ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
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  • required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 11 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

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