A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment
Model scores of the 29,894 trials active now.
Model score 13% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (927 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2020-07-31, after 2012-11-27 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2020-07-31. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: metastaticmultiplepriorunresectabletherapy
Phrases that lowered it: breast cancerher2hepatitis virustrastuzumabparticipant -
Phase: 3 (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Drug's FAERS reports with a death: 28.6% (raises risk) · Drug's FDA history
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Design: single group (raises risk) · Design
-
Disease area, cancer: Yes (raises risk) · Disease area
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Sponsor's past termination rate: 9.1% (raises risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 222 (lowers risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- non randomized (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 581 (typical: 32)
- Sponsor's past termination rate
- 9.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 222 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 21 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 18 (typical: 412.5)
- Drug's FAERS reports marked serious
- 85.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 28.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- ado trastuzumab emtansine, trastuzumab emtansine
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- A Study of Trastuzumab-Mcc-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer NCT00679211 · started 2008 · scored riskier than 61% of active trials completed
- A Study of Trastuzumab Emtansine, Paclitaxel, and Pertuzumab in Patients With HER2-Positive, Locally Advanced or Metastatic Breast Cancer NCT00951665 · started 2009 · scored riskier than 77% of active trials completed
- Study of the Pharmacokinetics and Safety of Trastuzumab Emtansine in Chinese Participants With Locally Advanced Inoperable or Metastatic HER2+ Breast Cancer NCT03153163 · started 2017 · scored riskier than 30% of active trials completed
- A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer NCT00829166 · started 2009 · scored riskier than 33% of active trials completed
- A Study to Determine Best Tumor Response With Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2 (HER2) Overexpressing Solid Tumors NCT02999672 · started 2016 · scored riskier than 69% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.