This page shows what was measured, who it was measured in, and what that does not settle.
What Trastuzumab deruxtecan does in the body
Unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regime
From the FDA-approved label: Fam-trastuzumab deruxtecan-nxki is a HER2-directed antibody-drug conjugate. The antibody is a humanized anti-HER2 IgG1. The small molecule, DXd, is a topoisomerase I inhibitor attached to the antibody by a cleavable linker. Following binding to HER2 on tumor cells, fam-trastuzumab deruxtecan-nxki undergoes internalization and intracellular linker cleavage by lysosomal enzymes. Upon release, the membrane-permeable DXd causes DNA damage and apoptotic cell death.
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.
What the registries record it as
The substance registry classes this as protein.
FDA substance registry · 5384HK7574 · read 2026-08-29
Where each sentence above came from
The recorded explanation is written in label language rather than for a beginner. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
No statement of the main limit is recorded.
The four opening statements run to 95 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.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
What happened in people◇Read 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.
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.
✗ The study did not show it
Who was studied
NCT01042379
How many people
5000
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. Intravenous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Objective Response Rate defined as % of participants in a cohort with complete or partial response or with stable disease according to standard response criteria
✗ The study did not show it
Who was studied
NCT02693535
How many people
4200
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. Intravenous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Detection rate of circulating biomarkers in cohort 1
✗ The study did not show it
Who was studied
NCT05088395
How many people
2050
Study design
Not applicable
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. Intravenous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Invasive Disease-free Survival (IDFS) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment
✗ The study did not show it
Who was studied
NCT04622319
How many people
1600
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. Intravenous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment
✗ The study did not show it
Who was studied
NCT04784715
How many people
1157
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. Intravenous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · a recorded source, not a stored snapshot
Objective Response Rate (ORR)
✗ The study did not show it
Who was studied
NCT03424005
How many people
1132
Study design
Phase 1/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. Intravenous
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
FDA label (openFDA SPL) · 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 is missing or unclear◇Read 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.
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for: HER2-Positive Early Breast Cancer as neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorized test followed by a taxane, trastuzumab, and pertuzumab (THP).
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: “Safety and effectiveness of ENHERTU have not been established in pediatric patients.”
US prescribing information · 7e67e73e-ddf4-4e4d-8b50-09d7514910b6 · read 2026-08-30
On older people, the label states: “ENHERTU as Monotherapy Of the 2233 patients treated with ENHERTU 5.4 mg/kg, 28% were 65 years or older and 6% were 75 years or older.”
US prescribing information · 7e67e73e-ddf4-4e4d-8b50-09d7514910b6 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Based on its mechanism of action, ENHERTU can cause fetal harm when administered to a pregnant woman.”
US prescribing information · 7e67e73e-ddf4-4e4d-8b50-09d7514910b6 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There is no data regarding the presence of fam-trastuzumab deruxtecan-nxki in human milk, the effects on the breastfed child, or the effects on milk production.”
US prescribing information · 7e67e73e-ddf4-4e4d-8b50-09d7514910b6 · read 2026-08-30
On people with reduced liver function, the label states: “No dose adjustment of ENHERTU is recommended in patients with mild (total bilirubin ≤ULN and any AST >ULN or total bilirubin >1 to 1.5 times ULN and any AST) or moderate (total bilirubin >1.5 to 3 times ULN and any AST) hepatic impairment.”
US prescribing information · 7e67e73e-ddf4-4e4d-8b50-09d7514910b6 · read 2026-08-30
On people with reduced kidney function, the label states: “No dose adjustment of ENHERTU is recommended in patients with mild (creatinine clearance [CLcr] 60 to <90 mL/min) or moderate (CLcr 30 to <60 mL/min) renal impairment [see Clinical Pharmacology (12.3) ] .”
US prescribing information · 7e67e73e-ddf4-4e4d-8b50-09d7514910b6 · 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 take◇Read 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 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 (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
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 take◇Read 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
Still being tested
❝ 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
✎ 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
Sold as injection, powder, lyophilized, for solution, given by the intravenous route.
✎ 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.
What it would be like to take∅Nothing 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 unclear◇Read 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
✎ 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
4 products list this as an active ingredient in the United States drug directory. 4 of them contain it and nothing else.
FDA National Drug Code directory · 68594-130 · read 2026-08-29
They are sold as injection, powder, lyophilized, for solution, liquid and powder, for solution, taken intravenous.
FDA National Drug Code directory · 68594-130 · read 2026-08-29
1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 7e67e73e-ddf4-4e4d-8b50-09d7514910b6 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 7e67e73e-ddf4-4e4d-8b50-09d7514910b6 · read 2026-08-29
Enhertu is intravenous at 3 DOSAGE FORMS AND STRENGTHS For injection: 100 mg of fam-trastuzumab deruxtecan-nxki as a white to yellowish white lyophilized powder in a single-dose vial for reconstitution and further dilution For injection: 100 mg…, recorded as fda label in effect 2026-05-15 in the United States.
US prescribing information · 7e67e73e-ddf4-4e4d-8b50-09d7514910b6 · 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.
What it would be like to take◇Read 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, investigational agent. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Trastuzumab deruxtecan 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 unclear◇Read 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.
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 deruxtecan 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 people◇Read 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.
Where else this substance is registered
FDA substance identifier (UNII)
5384HK7574
CAS registry number
1826843-81-5
WHO international nonproprietary name list entry
10516
RxNorm concept
2267582
EMA substance identifier
100000174462
DrugBank
DB14962
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: Written into the record, not signed off.
✗ 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 unclear◇Read 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
The earliest marketing start date recorded for a listed product is 20190522.
FDA National Drug Code directory · 68594-130 · read 2026-08-29
What is missing or unclear◇Read 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
9 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.
How close this is to real life — found nothing in the sources checked.
The path through the body — found nothing in the sources checked.
Felt, measured, or meaningful — 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 (10)
Q2
On the Trastuzumab deruxtecan label: indicated for what?
"ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for: HER2-Positive Early Breast Cancer as neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorized test followed by a taxane, trastuzumab, and…": indications and usage on Trastuzumab deruxtecan's label. DailyMed label · 7e67e73e-ddf4-4e4d-8b50-09d7514910b6 · 2026-05-15
Q3
150 registered trials of Trastuzumab deruxtecan — at which phases?
Registered studies posting no result
124 of 150
150 registered studies of Trastuzumab deruxtecan: 80 phase2, 40 phase1, 23 phase3, 18 na or unstated, 2 phase4, 1 early phase1, 1 na. CLINICALTRIALS_SNAPSHOT · 2026-09-01
3 with a PubMed record
Show the evidence
phase2
80
phase1
40
phase3
23
na or unstated
18
phase4
2
early phase1
1
9 more recorded rows
na
1
recruiting
68
active not recruiting
32
completed
19
not yet recruiting
19
terminated
6
unknown
4
enrolling by invitation
1
withdrawn
1
recorded 2026-09-01 · last checked 2026-09-04
Q4
7 of Trastuzumab deruxtecan's trials stopped: accrual/recruitment, funding/business, other?
accrual/recruitment (2), funding/business (3) and other (2): Trastuzumab deruxtecan's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"The last participant was transitioned to alternative study."; 7 of 150 registered studies
Show the evidence
Trial
NCT03248492
terminated; "The last participant was transitioned to alternative study."
NCT03505710
terminated; "Last participant transitioned to alternative study."
NCT05091528
terminated; "Sponsor decision based on strategic re-alignment"
NCT05097599
terminated; "Business decision and enrollment difficulties"
NCT05744375
terminated; "The study stopped due to insufficient accrual (only two patients were included), and the sponsor has decided on its premature termination."
NCT06231693
terminated; "The study was stopped due to a realignment of strategic priorities"
1 further recorded trialNCT06585969
withdrawn; "Lack of funding"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Trastuzumab deruxtecan's half-life is 5.4 to 5.7 days — which schedules were studied?
5.4 to 5.7 days; Elimination The median elimination half-life of fam-trastuzumab deruxtecan-nxki is 5.4 to 5.7 days.
metabolismpharmacokinetics
Metabolism The monoclonal antibody is expected to be degraded into small peptides and amino acids via catabolic pathways.
recorded 2026-05-15 · last checked 2026-09-04
Q6
Which running trial of Trastuzumab deruxtecan could settle lifespan?
NCT04494425 measures Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2 (HER2)-Low Population, reading out 2026-06-19.
31 open trials; n 866; "Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer"
Show the evidence
Trial
NCT04494425
"Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer"; n 866; "Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2 (HER2)-Low Population"; 2026-06-19
NCT06551220
"Efficacy of Trastuzumab Deruxtecan in Metastatic Breast Cancer With Different HER2 Expression Patterns"; n 800; "Progression-free survival (PFS)"; 2026-07
NCT03529110
"DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]"; n 524; "Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane"; 2026-07-30
NCT03734029
"Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]"; n 557; "Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer"; 2026-08-01
NCT04704934
"Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04)"; n 490; "Overall Survival in Participants Who Were Administered Trastuzumab Deruxtecan Compared With Ramucirumab in Combination With Paclitaxel"; 2026-08-31
NCT06250777
"Efficacy and Safety of T-DXd in HER2-mutant Advanced Lung Cancer Patients With Asymptomatic Brain Metastases"; n 27; "Median Intracranial Progression-free survival(icPFS) as defined by RANO criteria"; 2026-12
14 further recorded trials
NCT05048797
"A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations"; n 454; "Progression Free Survival (PFS) by Blinded Independent Central Review (BICR)"; 2027-07-30
NCT06486883
"Safety and Efficacy of T-DXd vs. CDK4/6i-based ET as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype"; n 200; "Progression-free survival (PFS)"; 2028-01
NCT04622319
"A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)"; n 1600; "Invasive Disease-free Survival (IDFS) in Participants Who Were Administered Trastuzumab Deruxtecan (T-DXd) Compared With Trastuzumab Emtansine (T-DM1) Treatment"; 2028-06-20
NCT06102824
"Organoid-based Functional Precision Therapy for Advanced Breast Cancer"; n 252; "Progression-free survival"; 2028-06-30
NCT07150208
"T-DXd With or Without Bevacizumab for HER2-low Breast Cancer With Brain Metastasis"; n 140; "Progression Free Survival(PFS)"; 2028-09
NCT07678957
"A Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent/Metastatic Breast Cancer"; n 120; "Progression-free survival (PFS)"; 2028-12
NCT07368543
"Sequencing SG vs. T-DXd in HER2-Low/TROP2-High Metastatic Breast Cancer"; n 216; "Progression-Free Survival 1 (PFS1)"; 2028-12-01
NCT07180264
"Trastuzumab Deruxtecan in Advanced Breast Cancer"; n 118; "Progression-Free Survival (PFS)"; 2029-02
NCT07151586
"Testing Two Different Drugs (Sacituzumab-govitecan and Trastuzumab-deruxtecan) Combinations Prescribed in an Alterning Pattern to Patients With Metastatic or Locally Advanced Triple-negative Breast Cancer"; n 260; "Overall survival (OS)"; 2029-10
NCT07152782
"T-DXd With or Without Neratinib for HER2 Positive Breast Cancer With Brain Metastasis"; n 202; "Progression Free Survival(PFS)"; 2029-11
NCT06832202
"A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients"; n 50; "Progression-Free Survival (PFS)"; 2029-12-01
NCT04784715
"Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09)"; n 1157; "Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment"; 2029-12-30
NCT06731478
"Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer"; n 726; "Progression Free Survival (PFS)"; 2030-02-01
NCT07683754
"T-DXd Based Therapy Followed by Endocrine Therapy Plus Dual HER2 Blockade in First-line HER2+/ HR+ Metastatic Breast Cancer and Retreatment With T-DXd"; n 200; "Progression-free Survival (PFS) Rate at 24 Months"; 2030-08-28
Q7
Which 3 trials of Trastuzumab deruxtecan posted no result?
Posted no result
3 of 3 completed trials
Registrations
NCT04752059, NCT05458401 and NCT06504719
Completion dates
oldest 2023-05-01; newest 2024-09-01
Show the evidence
Trial
NCT04752059
2023-05-01
NCT05458401
2023-12-01
NCT06504719
2024-09-01
Q8
At the median, Trastuzumab deruxtecan's trials enrolled 111.5 people — anything larger?
Median enrolment
111.5
Largest enrolment
4200
Registered trials counted
150
Q9
What do 484 spontaneous reports say about Trastuzumab deruxtecan — 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 deruxtecan appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 484 reaction mentions were counted: nausea 121; fatigue 60; interstitial lung disease 59; disease progression 50. FAERS via Open Targets · CHEMBL4297844 · 2026-06-24
Show the evidence
nausea
121
fatigue
60
interstitial lung disease
59
disease progression
50
vomiting
46
diarrhoea
42
4 more recorded rows
pneumonitis
33
alopecia
29
decreased appetite
24
thrombocytopenia
20
recorded 2026-06-24 · last checked 2026-09-04
Q10
Which 10 reactions does Trastuzumab deruxtecan's label not list?
Drug Interaction Studies Clinical Studies No clinically significant differences in pharmacokinetics of fam-trastuzumab deruxtecan-nxki or DXd were observed when used concomitantly with itraconazole (strong CYP3A inhibitor) or ritonavir (strong CYP3A inhibitor and OATP inhibitor).
pharmacokinetics
In Vitro Studies CYP450 Enzymes : DXd does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A nor induce CYP1A2, CYP2B6, or CYP3A.
pharmacokinetics
Transporter Systems : DXd is not an inhibitor of OAT1, OAT3, OCT1, OCT2, OATP1B1, OATP1B3, MATE1, MATE2-K, P-gp, BCRP, or BSEP.
pharmacokinetics
DXd is a substrate of OATP1B1, OATP1B3, MATE2-K, P-gp, MRP1, and BCRP.
clinical_pharmacology
DXd is primarily metabolized by CYP3A4.
2 more recorded rows
Interaction statementclinical_pharmacology
Drug Interaction Studies Clinical Studies No clinically significant differences in pharmacokinetics of fam-trastuzumab deruxtecan-nxki or DXd were observed when used concomitantly with itraconazole (strong CYP3A inhibitor) or ritonavir (strong CYP3A inhibitor and OATP inhibitor).
Interaction statementclinical_pharmacology
In Vitro Studies CYP450 Enzymes : DXd does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A nor induce CYP1A2, CYP2B6, or CYP3A.
ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 5 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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