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Trastuzumab-Dttb

  • Biologic
  • Prescription only
  • 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-Dttb does in the body

Ontruzant is a HER2/neu receptor antagonist indicated in adults for: The treatment of HER2-overexpressing breast cancer.

The HER2 (or c-erbB2) proto-oncogene encodes a transmembrane receptor protein of 185 kDa, which is structurally related to the epidermal growth factor receptor. Trastuzumab products have been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumor cells that overexpress HER2. Trastuzumab products are mediators of antibody-dependent cellular cytotoxicity (ADCC). In vitro , trastuzumab product-mediated ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2.

Why people take it. Ontruzant is a HER2/neu receptor antagonist indicated in adults for: The treatment of HER2-overexpressing breast cancer.

What happened in people

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

A fixed RNAWiki sentence

Where this came from

Wording RNAWiki always uses, not a finding about this substance.

No reviewed claim names a result for any goal on this record.

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
Where each sentence above came from

The use the label states, quoted from it. No plain-language version of this sentence has been written.

The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.

No statement of the main limit is recorded.

The four opening statements run to 127 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.

Biomarker

A biomarker is a number from a test that stands in for something about health.

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.

What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.

A measurable indicator used as a substitute for a clinical outcome of interest.

Stand-in result

A stand-in result is a number measured because the real result takes too long.

A picture of it, and where the picture fails

It is like judging a journey by the speedometer rather than by arriving.

Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.

What people get wrong. A stand-in result is often reported as the result itself.

A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.

Formulation

A formulation is the exact made-up form a substance comes in.

A picture of it, and where the picture fails

It is like the difference between a whole bean and instant coffee.

Where that stops being true. Coffee tastes different. A formulation can change how much reaches the blood.

What people get wrong. Two products with the same name are assumed to behave the same. They often do not.

The specific composition and physical form of a product, including salt, excipients and release profile.

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.

Objective response rate (ORR)

The study did not show it

Who was studied
NCT02465060
How many people
6452
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

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.

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • FDA nonproprietary naming guidance for biological products · a recorded source, not a stored snapshot

Duration of DFS

The study did not show it

Who was studied
NCT00005970
How many people
3436
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

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.

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • FDA nonproprietary naming guidance for biological products · a recorded source, not a stored snapshot

Percentage of Patients Alive and Free From Invasive Disease (IDFS)

The study did not show it

Who was studied
NCT01275677
How many people
3270
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

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.

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • FDA nonproprietary naming guidance for biological products · a recorded source, not a stored snapshot

Recurrence-free survival (RFS)

The study did not show it

Who was studied
NCT04266249
How many people
2175
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

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.

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • FDA nonproprietary naming guidance for biological products · a recorded source, not a stored snapshot

Ipsilateral Invasive Breast Cancer, Ipsilateral Skin Cancer Recurrence, or Ipsilateral DCIS-Free Survival

The study did not show it

Who was studied
NCT00769379
How many people
2014
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

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.

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • FDA nonproprietary naming guidance for biological products · a recorded source, not a stored snapshot

Overall survival (OS) (Cohort A)

The study did not show it

Who was studied
NCT07578116
How many people
562
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

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.

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • FDA nonproprietary naming guidance for biological products · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 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.7 registered measures of this kind. 3 written-up studies measured this and did not show a benefit.
  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 Evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.1 registered measure of this kind.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.1 registered measure of this kind.
  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 No evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
  8. Cells in a dish No evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
  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 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.

  • reported health related quality of life fact b

Measured

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

  • area under the concentration time curve at steady state

Meaningful

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

  • disease free survival
  • recurrence free survival
  • progression free survival
  • invasive disease free survival between the 2 arms
  • progression free survival rate
  • event free survival
  • overall survival

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 (27)
  • duration of dfs
  • frequency and duration of objective response
  • acute treatment related toxicity
  • pcr rate
  • objective response rate
  • alive and free from invasive disease
  • the subgroups who had a pathologic complete response
  • a pathologic complete response
  • grade 3 or higher toxicity per study arm
  • maximum tolerated dose and/or recommended phase ii dose
  • clinical benefit rate
  • neutropenia
  • paclitaxel related neuropathy
  • response to neoadjuvant chemotherapy determined at surgery
  • dose limiting toxicities during dose escalation
  • overall response rate
  • dose limiting toxicities
  • safety run in phase 1b/2
  • incidence of dose limiting toxicities
  • incidence of adverse events

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.

  • Breast and stomach cancers driven by an over-copied growth receptor

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.

What the label states about particular groups

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

    US prescribing information · ce2a2492-85e3-4b0a-872a-047f44e4203d · 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 · ce2a2492-85e3-4b0a-872a-047f44e4203d · 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 · ce2a2492-85e3-4b0a-872a-047f44e4203d · 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 · ce2a2492-85e3-4b0a-872a-047f44e4203d · read 2026-08-30

Where the result stopped carrying

  • 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.

A different form was studied

The studied form is not the form on the shelf.

On this record: This record is linked to 1 related forms. Evidence does not carry across all of them.

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 (9)
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

Prescription only

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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No form or route is recorded.

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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing is recorded about product quality.

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.

What it would be like to takeNothing found in the sources checked

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.

Nothing found in the sources checked

No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.

The sources listed were searched and held nothing. That is not the same as nothing existing.

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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

The exact form studied is not recorded.

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

  • Ontruzant is intravenous at 3 DOSAGE FORMS AND STRENGTHS For injection: 150 mg of Ontruzant as a white to pale yellow, preservative-free lyophilized powder in a single-dose vial., recorded as fda label in effect 2026-04-20 in the United States.

    US prescribing information · ce2a2492-85e3-4b0a-872a-047f44e4203d · read 2026-08-30

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

Names and forms linked to this record

  • Biosimilar of

    Trastuzumab

    Evidence on this page does not automatically apply to this one.

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-Dttb 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

What nobody knows yet

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

How much did people take in the studies?

The sources RNAWiki checked hold nothing for this field.

Why it matters. A result belongs to an amount. Without the amount the result floats free.

What would answer it

A stored source that records 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.

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

A stored source that records 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 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-Dttb 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 peopleNothing found in the sources checked

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.

Nothing found in the sources checked

No traced study record is stored for this substance.

The sources listed were searched and held nothing. That is not the same as nothing existing.

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Quoted from a stored source.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

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

  • Passed

    Canonical metadata present

    slug and display name present

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 BLA761100, approved 20190118 to SAMSUNG BIOEPIS CO LTD.

    Drugs@FDA application register · BLA761100 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · BLA761100 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

7 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • What was measured, goal by goal — found nothing in the sources checked.
  • The path through the body — found nothing in the sources checked.
  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • Claims that go past the evidence — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

Recorded evidence blocks (8)

What did Trastuzumab-Dttb's largest trial (6452 people) and its longest (19 years) measure?


6452 people in Trastuzumab-Dttb's largest registered study, 19 years in its longest registered window, measuring Changes in Senescence and Secondary Biomarkers, Including TMEM, Mena, and 67LR. ClinicalTrials.gov · 2026-09-01

24 phase2, 13 phase1, 12 phase3, 2 phase4, 1 early phase1, 1 na; NCT04266249; 2038-12-31. Last human test completed 2026, NCT05504720.

Interpretation These counts include studies where Trastuzumab-Dttb 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
    24
  • phase1
    13
  • phase3
    12
  • phase4
    2
  • early phase1
    1
  • na
    1
1 more recorded row
  • Last recorded human test NCT05504720
    2026-08-05

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

Trastuzumab-Dttb was tested only in human — what did it show?


human: biomarker (45): the rungs where Trastuzumab-Dttb 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 Rat Dog Non-human primate Human biomarker
Show the evidence
  • human NCT01897441
    biomarker; Changes in Senescence and Secondary Biomarkers, Including TMEM, Mena, and 67LR; 45

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

10 of Trastuzumab-Dttb's trials stopped: accrual/recruitment, funding/business, other?


accrual/recruitment (4), funding/business (1) and other (5): Trastuzumab-Dttb's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Interventional component of study terminated prior to full enrollment"; 10 of 45 registered studies

Show the evidence

Trial

  • NCT01897441
    terminated; "Interventional component of study terminated prior to full enrollment"
  • NCT02774681
    terminated; "Slow accrual"
  • NCT03101748
    terminated; "\<75% accrued"
  • NCT03199885
    terminated; "Inadequate accrual rate"
  • NCT03432741
    terminated; "funding - sponsor filing Chapter 11 bankruptcy"
  • NCT03811418
    withdrawn; "Study approved with treatment regimen based on current guidelines. However, reimbursement of IMP was not feasible."
4 further recorded trials
  • NCT04108858
    terminated; "Inadequate accrual rate"
  • NCT04120246
    suspended; "Study placed on hold."
  • NCT05238831
    withdrawn; "Withdrawn due to a change in therapeutic interventions."
  • NCT05356897
    withdrawn; "no sites were regulatory ready and the SC took the study to a different group."

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

Which of a pathologic complete response, acute treatment related toxicity and alive and free from invasive disease did Trastuzumab-Dttb's trials measure?


a pathologic complete response, acute treatment related toxicity and alive and free from invasive disease lead 36 outcome terms across Trastuzumab-Dttb's trials. ClinicalTrials.gov · 2026-09-01

Interpretation pcr rate, area under the concentration time curve at steady state, objective response rate, disease free survival, alive and free from invasive disease and the subgroups who had a pathologic complete response follow.

Show the evidence
  • duration of dfs
    1
  • frequency and duration of objective response
    1
  • acute treatment related toxicity
    1
  • pcr rate
    1
  • area under the concentration time curve at steady state
    1
  • objective response rate
    1
14 more recorded rows
  • disease free survival
    1
  • alive and free from invasive disease
    1
  • the subgroups who had a pathologic complete response
    1
  • a pathologic complete response
    1
  • grade 3 or higher toxicity per study arm
    1
  • maximum tolerated dose and/or recommended phase ii dose
    1
  • clinical benefit rate
    1
  • neutropenia
    1
  • paclitaxel related neuropathy
    1
  • recurrence free survival
    1
  • response to neoadjuvant chemotherapy determined at surgery
    1
  • dose limiting toxicities during dose escalation
    1
  • overall response rate
    1
  • progression free survival
    1

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

Which of Trastuzumab-Dttb's 12 ongoing trials reports first?


12 registered trials of Trastuzumab-Dttb are open; earliest completion 2026-09-25. ClinicalTrials.gov · 2026-09-01

Objective response rate (ORR); Response to Neoadjuvant Chemotherapy Determined at Surgery (Lumpectomy or Mastectomy).; latest 2038-12-31

Show the evidence

Trial

  • 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
  • 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
  • NCT04266249
    "CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy"; n 2175; "Recurrence-free survival (RFS)"; 2038-12-31
  • NCT04285671
    "Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer"; n 30; "Identification of the recommended phase II dose (R2PD) regimen for combination osimertinib, necitumumab, trastuzumab (ONT) therapy (Phase Ib)"; 2027-12-02
  • NCT04329065
    "Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer"; n 25; "Enumeration of the number of T-bet+, CD4+, and CD8+ T-cells in tumor infiltrating lymphocytes (TIL) after combination immune-chemotherapy"; 2027-12-31
  • NCT05319873
    "Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer"; n 18; "Maximum tolerated dose (MTD) (Phase Ib)"; 2028-04-01
6 further recorded trials
  • NCT05376878
    "An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis"; n 10; "Percent of patients with quantifiable 64Cu-DOTA-trastuzumab PET uptake"; 2027-04-27
  • 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"; n 146; "Progression free survival (PFS) (HER2-Positive Cohort)"; 2032-07-31
  • NCT06136897
    "Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 Gene Found in Their Tumors (MATCH - Subprotocol J)"; n 35; "Objective Response Rate"; 2027-01-15
  • NCT06686394
    "Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)"; n 81; "Number of Participants Experiencing Dose-Limiting Toxicity (DLT)"; 2030-04-18
  • NCT07407920
    "Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial"; n 120; "Event free survival (EFS)"; 2027-09-30
  • NCT07578116
    "Adding Surgery and Radiation to the Usual Treatment for HER2-Positive Breast Cancer That Had Already Spread at Diagnosis"; n 562; "Overall survival (OS) (Cohort A)"; 2033-05-31

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

Which running trial of Trastuzumab-Dttb could settle lifespan?


NCT07407920 measures Event free survival (EFS), reading out 2027-09-30.

4 open trials; n 120; "Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial"

Show the evidence

Trial

  • NCT07407920
    "Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial"; n 120; "Event free survival (EFS)"; 2027-09-30
  • 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"; n 146; "Progression free survival (PFS) (HER2-Positive Cohort)"; 2032-07-31
  • NCT07578116
    "Adding Surgery and Radiation to the Usual Treatment for HER2-Positive Breast Cancer That Had Already Spread at Diagnosis"; n 562; "Overall survival (OS) (Cohort A)"; 2033-05-31
  • NCT04266249
    "CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy"; n 2175; "Recurrence-free survival (RFS)"; 2038-12-31

Which 4 trials of Trastuzumab-Dttb posted no result?


Posted no result
4 of 4 completed trials
Registrations
NCT00005970, NCT00006089, NCT01434303 and NCT02152943
Completion dates
oldest 2010-01-27; newest 2020-12-14
Show the evidence

Trial

  • NCT00005970
    2010-01-27
  • NCT00006089
    2010-01-31
  • NCT01434303
    2016-02-16
  • NCT02152943
    2020-12-14

At the median, Trastuzumab-Dttb's trials enrolled 37 people — anything larger?


Median enrolment
37
Largest enrolment
6452
Registered trials counted
45
Where it is registered
Identifiers, relations and other names

The exact record

CAS number
180288-69-1
RxCUI
224905

Relations

Trade name
Ontruzant
Development code
4D5V8, ABP-980, ABP980, BMAB-200, CT-P6, CTP-6, CTP6, EG-12014
Also called
CANHERA, DMB-3111
Sources (4)

Sources

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

How these records are assembled · Which registers were checked

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  • source coverage passed: 4 source rows
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