Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 5% 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 in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2021-06-28, after 2017-12-21 start.
Reason given by the sponsor: “business”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
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 2021-06-28. 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: metastaticmetastasesbrainrandomizationcapecitabine
Phrases that lowered it: aminotransferaseendocrinepatients withmalehealth -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 27.5% (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
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Design: parallel (raises risk) · Design
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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 type: industry (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Sponsor's past trials: 0 (raises risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
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Disease area, dermatology: Yes (raises risk) · Disease area
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Responsible party: sponsor (lowers risk) · Design
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Keywords listed: 10 (lowers risk) · Design
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Collaborators: 0 (raises risk) · Design
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
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 10 (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 42296 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 7640 (typical: 412.5)
- Drug's FAERS reports marked serious
- 83.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 27.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- capecitabine, tesetaxel
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
- Tesetaxel Plus Reduced Dose of Capecitabine in Patients With HER2 Negative, HR Positive, LA/MBC NCT03858972 · started 2019 · scored riskier than 81% of active trials terminated
- PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection NCT03079011 · started 2017 · scored riskier than 54% of active trials completed
- Tucatinib, Trastuzumab, and Capecitabine for the Treatment of HER2+ LMD NCT03501979 · started 2019 · scored riskier than 93% of active trials terminated
- Breast Cancer Study: Paclitaxel Versus Paclitaxel Plus Sorafenib in Second- or Third-line Treatment NCT01320111 · started 2010 · scored riskier than 94% of active trials completed
- Phase Ib/II Trial of coPANlisib in Combination With Trastuzumab in HER2-positive Breast Cancer. (Panther Study) NCT02705859 · started 2016 · scored riskier than 54% 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.