Tesetaxel Plus Reduced Dose of Capecitabine in Patients With HER2 Negative, HR Positive, LA/MBC
Model scores of the 29,894 trials active now.
Model score 23% for any early termination, 11% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 22% of the time (1,598 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2021-06-11, after 2019-02-05 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 2021-06-11. 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: breast cancerher2metastaticpriorpatients must
Phrases that lowered it: endocrinehepaticmalehormone14 -
Phase: 2 (raises risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
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Design: single group (raises risk) · Design
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Drug's FAERS reports with a death: 25.6% (raises risk) · Drug's FDA history
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Number of arms: 1 (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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Sponsor's past trials: 0 (raises risk) · Sponsor's track record
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Disease area, dermatology: Yes (raises risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports marked serious: 81.9% (lowers risk) · Drug's FDA history
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Collaborators: 0 (raises risk) · Design
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Keywords listed: 13 (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
- 2
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 13 (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
- 1 (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
- 49436 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 6251 (typical: 412.5)
- Drug's FAERS reports marked serious
- 81.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 25.6% (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 vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC NCT03326674 · started 2017 · scored riskier than 50% of active trials terminated
- DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease NCT04420598 · started 2020 · scored riskier than 92% of active trials completed
- PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection NCT03079011 · started 2017 · scored riskier than 54% 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
- A Pilot Study of the Combination of Entinostat With Capecitabine in High Risk Breast Cancer After Neo-adjuvant Therapy NCT03473639 · started 2019 · 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.