This page shows what was measured, who it was measured in, and what that does not settle.
What Trastuzumab emtansine does in the body
HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately
From the FDA-approved label: Ado-trastuzumab emtansine is a HER2-targeted antibody-drug conjugate. The antibody is the humanized anti-HER2 IgG1, trastuzumab. The small molecule cytotoxin, DM1, is a microtubule inhibitor. Upon binding to sub-domain IV of the HER2 receptor, ado-trastuzumab emtansine undergoes receptor-mediated internalization and subsequent lysosomal degradation, resulting in intracellular release of DM1-containing cytotoxic catabolites. Binding of DM1 to tubulin disrupts microtubule networks in the cell, which results in cell cycle arrest 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 · SE2KH7T06F · 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 100 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.
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. 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
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
Percentage of Participants With Adverse Events of Primary Interest (AEPIs)
✗ The study did not show it
Who was studied
NCT01702571
How many people
2185
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. 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
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. 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
Pathological complete response rate
✗ The study did not show it
Who was studied
NCT07239271
How many people
2000
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. 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 the Node-Positive Subpopulation
✗ The study did not show it
Who was studied
NCT01966471
How many people
1846
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
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.
KADCYLA is a HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for: the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.
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 KADCYLA have not been established in pediatric patients.”
US prescribing information · 23f3c1f4-0fc8-4804-a9e3-04cf25dd302e · read 2026-08-30
On older people, the label states: “Of the 495 patients who were randomized to KADCYLA in EMILIA [see Clinical Studies (14.1) ] , 65 patients (13%) were ≥ 65 years of age and 11 patients (2%) were ≥ 75 years of age.”
US prescribing information · 23f3c1f4-0fc8-4804-a9e3-04cf25dd302e · read 2026-08-30
On people who are pregnant, the label states: “If KADCYLA is administered during pregnancy, or if a patient becomes pregnant while receiving KADCYLA or within 7 months following the last dose of KADCYLA, health care providers and patients should immediately report KADCYLA exposure to Genentech at 1-888-835-2555.”
US prescribing information · 23f3c1f4-0fc8-4804-a9e3-04cf25dd302e · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of ado-trastuzumab emtansine in human milk, the effects on the breastfed infant, or the effects on milk production.”
US prescribing information · 23f3c1f4-0fc8-4804-a9e3-04cf25dd302e · read 2026-08-30
On people with reduced liver function, the label states: “No adjustment to the starting dose is required for patients with mild or moderate hepatic impairment [see Clinical Pharmacology (12.3) ] .”
US prescribing information · 23f3c1f4-0fc8-4804-a9e3-04cf25dd302e · read 2026-08-30
On people with reduced kidney function, the label states: “No dedicated renal impairment trial for KADCYLA has been conducted.”
US prescribing information · 23f3c1f4-0fc8-4804-a9e3-04cf25dd302e · 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
5 products list this as an active ingredient in the United States drug directory. 5 of them contain it and nothing else.
FDA National Drug Code directory · 43624-041 · read 2026-08-29
They are sold as injection, powder, lyophilized, for solution and liquid, taken intravenous.
FDA National Drug Code directory · 43624-041 · 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 · 23f3c1f4-0fc8-4804-a9e3-04cf25dd302e · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 23f3c1f4-0fc8-4804-a9e3-04cf25dd302e · read 2026-08-29
KADCYLA is intravenous at 3 DOSAGE FORMS AND STRENGTHS Lyophilized powder in single-dose vials: 100 mg per vial or 160 mg per vial of ado-trastuzumab emtansine., recorded as fda label in effect 2026-04-01 in the United States.
US prescribing information · 23f3c1f4-0fc8-4804-a9e3-04cf25dd302e · 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 emtansine 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.
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 emtansine 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)
SE2KH7T06F
CAS registry number
1018448-65-1
ChEMBL
CHEMBL2109399
WHO international nonproprietary name list entry
9295
RxNorm concept
1371041
EMA substance identifier
100000128434
DrugBank
DB05773
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 20121101.
FDA National Drug Code directory · 43624-041 · 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 (11)
Q2
On the Trastuzumab emtansine label: indicated for what?
"KADCYLA is a HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for: the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: received prior therapy for…": indications and usage on Trastuzumab emtansine's label. DailyMed label · 23f3c1f4-0fc8-4804-a9e3-04cf25dd302e · 2026-04-01
Q3
110 registered trials of Trastuzumab emtansine — at which phases?
Registered studies posting no result
71 of 110
110 registered studies of Trastuzumab emtansine: 61 phase2, 25 phase1, 25 phase3, 7 na or unstated, 2 na, 1 early phase1, 1 phase4. CLINICALTRIALS_SNAPSHOT · 2026-09-01
safety (3), futility/efficacy (1), accrual/recruitment (7), funding/business (1) and other (7): Trastuzumab emtansine's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01
"The sponsor decided to terminate study after 70% of participants had experienced a progression-free survival event."; 19 of 110 registered studies
Show the evidence
Trial
NCT01702558
terminated; "The sponsor decided to terminate study after 70% of participants had experienced a progression-free survival event."
NCT02318901
terminated; "PI no longer at sight. Results not collected"
NCT02658084
terminated; "Terminated due to low accrual and toxicity concerns."
NCT02725541
withdrawn; "loss of funding support"
NCT03203616
withdrawn; "As most HER2+ patient develop brain mets while on/after having received TDM1, it has proven to be an insurmountable challenge to recruit patients"
NCT03429101
terminated; "Dose limiting toxicity"
13 further recorded trials
NCT03709082
terminated; "Low accrual"
NCT03784599
terminated; "insufficient effectiveness"
NCT03878524
terminated; "Low accrual"
NCT03894007
terminated; "Security and effect data from another ongoing study."
NCT04042051
terminated; "Accrual rate to date was too low to finish the trial in a reasonable timeframe"
NCT04296942
terminated; "One participant was accrued, and the study was stopped due to new safety data from the company for M7824 and slow accrual."
NCT04298918
terminated; "Decision to discontinue the study based on broader development and strategic prioritisation. The Sponsor concludes there is no benefit-risk impact on the CO41863 study."
NCT04351230
withdrawn; "There are no patients enrolled on this study and all efforts are being discontinued"
NCT04419181
withdrawn; "Change in the landscape of current treatment of early stage breast cancer. Larger clinical trials answering similar questions are expected to result in the next few years."
NCT04675827
terminated; "Serious concerns on the slow recruitment of the study that impacts the robustness of the scientific rationale and the study financial provision. It aims to assess carefully the situation and to evaluate the potential solutions to overcome…"
NCT04740918
terminated; "Due to low enrollment, the Sponsor decided to prematurely terminate the study"
NCT05238831
withdrawn; "Withdrawn due to a change in therapeutic interventions."
NCT06595563
terminated; "Study logistics or limited study population, as defined by the iclusion/exclusion criteria, leading to a poor recruitment"
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Trastuzumab emtansine used KADCYLA 160 MG Injection — over how long?
studies of Trastuzumab emtansine used the recorded amount. ClinicalTrials.gov · 2026-09-01
1 recorded entry; human; also "KADCYLA 160 MG Injection"
Show the evidence
humanNCT03203616
KADCYLA 160 MG Injection
recorded 2026-09-01 · last checked 2026-09-04
Q6
Trastuzumab emtansine's half-life is 4 days — which schedules were studied?
4 days, the half-life Trastuzumab emtansine's label states: "Elimination Based on population pharmacokinetic analysis, following intravenous infusion of KADCYLA, the clearance of the ADC was 0.68 L/day and the elimination half-life (t 1/2 ) was approximately 4 days." DailyMed label · 23f3c1f4-0fc8-4804-a9e3-04cf25dd302e · 2026-04-01
Show the evidence
half lifepharmacokinetics
4 days; Elimination Based on population pharmacokinetic analysis, following intravenous infusion of KADCYLA, the clearance of the ADC was 0.68 L/day and the elimination half-life (t 1/2 ) was approximately 4 days.
metabolismpharmacokinetics
Metabolism In vitro studies indicate that DM1, the small molecule component of KADCYLA, undergoes metabolism by CYP3A4/5.
recorded 2026-04-01 · last checked 2026-09-04
Q7
Which running trial of Trastuzumab emtansine could settle lifespan?
NCT03529110 measures 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, reading out 2026-07-30.
16 open trials; n 524; "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]"
Show the evidence
Trial
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
NCT04301375
"Omission of Surgery and Sentinel Lymph Node Dissection in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti- HER2-based Neoadjuvant Therapy (ELPIS Trial)"; n 27; "To estimate the loco-regional invasive disease-free survival of patients who achieve a complete response"; 2027-07-15
NCT03587740
"ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer"; n 111; "Invasive Disease-free Survival Rate (IDFS)"; 2027-08-30
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
NCT06313086
"DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer"; n 442; "Progression-free survival (PFS) by BIRC"; 2028-02
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
10 further recorded trials
NCT06846437
"JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer"; n 228; "Progression-Free Survival (PFS) by BIRC"; 2028-12-31
NCT04620187
"Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas"; n 37; "2 Year Disease-free survival (DFS) Rate"; 2029-02-01
NCT03975647
"A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer"; n 466; "Progression-Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 Based on Investigator Assessment"; 2029-03-10
NCT06126640
"A Phase III, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy"; n 1615; "Invasive disease-free survival (IDFS)"; 2032-04
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
NCT06439693
"The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer"; n 72; "Disease Free Survival at 4 Years (DFS4)"; 2033-03-30
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
NCT04873362
"A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy"; n 1188; "Invasive Disease-free Survival (IDFS) in the Full Analysis Set (FAS)"; 2034-10-02
NCT04457596
"T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial"; n 1056; "Modified invasive disease-free survival (iDFS)"; 2035-05-31
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
Q8
Which 13 trials of Trastuzumab emtansine posted no result?
Posted no result
13 of 13 completed trials
Registrations
NCT01513083, NCT02135159, NCT01816035, NCT00833963, NCT03153163 and NCT02073916, and 7 more
Completion dates
oldest 2014-09; newest 2024-07
Show the evidence
Trial
NCT01513083
2014-09
NCT02135159
2017-03
NCT01816035
2017-04
NCT00833963
2017-04-13
NCT03153163
2018-09-27
NCT02073916
2018-12
7 further recorded trials
NCT01975142
2019-01-21
NCT02605915
2019-11-13
NCT01835236
2020-05-26
NCT01983501
2020-09-03
NCT03084939
2023-03-14
NCT02448420
2023-11-30
NCT02390427
2024-07
Q9
At the median, Trastuzumab emtansine's trials enrolled 125 people — anything larger?
Median enrolment
125
Largest enrolment
6452
Registered trials counted
110
Q10
What do 2000 spontaneous reports say about Trastuzumab emtansine — 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 emtansine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2000 reaction mentions were counted: nausea 333; thrombocytopenia 279; disease progression 264; platelet count decreased 219. FAERS via Open Targets · CHEMBL1743082 · 2026-06-24
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nausea
333
thrombocytopenia
279
disease progression
264
platelet count decreased
219
neuropathy peripheral
183
metastases to central nervous system
151
4 more recorded rows
epistaxis
150
alanine aminotransferase increased
149
aspartate aminotransferase increased
139
infusion related reaction
133
recorded 2026-06-24 · last checked 2026-09-04
Q11
Which 10 reactions does Trastuzumab emtansine's label not list?
alanine aminotransferase increased, aspartate aminotransferase increased and disease progression and 7 more reported for Trastuzumab emtansine, absent from its label. FAERS via Open Targets · CHEMBL1743082 · 2026-06-24
2 label terms; 10 reported and unlisted; 23f3c1f4-0fc8-4804-a9e3-04cf25dd302e
Show the evidence
alanine aminotransferase increased
count not stated
aspartate aminotransferase increased
count not stated
disease progression
count not stated
epistaxis
count not stated
infusion related reaction
count not stated
metastases to central nervous system
count not stated
4 more recorded rows
nausea
count not stated
neuropathy peripheral
count not stated
platelet count decreased
count not stated
thrombocytopenia
count not stated
recorded 2026-06-24 · last checked 2026-09-04
Q12
Trastuzumab emtansine and CYP3A4, P-GLYCOPROTEIN and P-GP: shared by which compounds?
In vitro studies indicate that DM1, the cytotoxic component of KADCYLA, is metabolized mainly by CYP3A4 and to a lesser extent by CYP3A5.
drug_interactions
Concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole) with KADCYLA should be avoided due to the potential for an increase in DM1 exposure and toxicity.
drug_interactions
Consider an alternate medication with no or minimal potential to inhibit CYP3A4.
drug_interactions
If concomitant use of strong CYP3A4 inhibitors is unavoidable, consider delaying KADCYLA treatment until the strong CYP3A4 inhibitors have cleared from the circulation (approximately 3 elimination half-lives of the inhibitors) when possible.
drug_interactions
If a strong CYP3A4 inhibitor is coadministered and KADCYLA treatment cannot be delayed, patients should be closely monitored for adverse reactions.
pharmacokinetics
In vitro, DM1 was a substrate of P-glycoprotein (P-gp).
2 more recorded rows
Interaction statementpharmacokinetics
Metabolism In vitro studies indicate that DM1, the small molecule component of KADCYLA, undergoes metabolism by CYP3A4/5.
Interaction statementclinical_pharmacology
In vitro, DM1 was a substrate of P-glycoprotein (P-gp).
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
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