T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial)
Model scores of the 29,894 trials active now.
Model score 27% for any early termination, 14% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (3,728 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 2022-06-15, after 2013-05-31 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 2022-06-15. 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: cancercellstumortreatingor equal
Phrases that lowered it: participantsbreastdrugtrialalcohol -
Sponsor's past termination rate: 13.9% (raises risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Disease area, cancer: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 42 (lowers risk) · Sponsor's track record
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Sponsor's past trials: 173 (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Design: parallel (raises risk) · Design
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Responsible party: principal investigator (lowers risk) · Design
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Drug's FAERS reports before start: 21514 (lowers risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 6074 (lowers risk) · Drug's FDA history
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Blinding: none (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
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Drugs with FDA adverse-event history: 4 (lowers risk) · Drug's FDA history
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Collaborators: 0 (raises risk) · Design
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Disease area, dermatology: Yes (raises risk) · Disease area
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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: 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
- academic or other
- Sponsor's past trials
- 173 (typical: 32)
- Sponsor's past termination rate
- 13.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 42 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 4 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 21514 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 6074 (typical: 412.5)
- Drug's FAERS reports marked serious
- 95.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 21.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- ado trastuzumab emtansine, paclitaxel, trastuzumab, 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
- Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy NCT00769379 · started 2008 · scored riskier than 66% of active trials completed
- A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer NCT01966471 · started 2014 · scored riskier than 18% of active trials completed
- Paclitaxel & Cyclophosphamide With or Without Trastuzumab Before Surgery in Treating Previously Untreated Breast Cancer NCT01750073 · started 2012 · scored riskier than 95% of active trials completed
- The Synergism Or Long Duration (SOLD) Study NCT00593697 · started 2008 · scored riskier than 51% of active trials completed
- A Study of the Efficacy and Safety of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) vs. Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease NCT00679341 · started 2008 · scored riskier than 85% 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.