ALERT: A Phase II Study of Alternating Eribulin and Hormonal Therapy in Pre-treated ER+ve Breast Cancer.
Model scores of the 29,894 trials active now.
Model score 22% 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 in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2018-07-24, after 2015-10-28 start.
Reason given by the sponsor: “enrollment”
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 2018-07-24. 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 cancermetastatic breasther2metastasesuln
Phrases that lowered it: ovarianaccordingboneaminotransferaseaged -
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: 11.7% (raises risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 61 (lowers risk) · Sponsor's track record
-
Design: single group (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports with a death: 20.3% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Disease area, dermatology: Yes (raises risk) · Disease area
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Sponsor's past trials: 137 (lowers risk) · Sponsor's track record
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Number of arms: 1 (raises risk) · Design
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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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Responsible party: sponsor (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
- 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
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 137 (typical: 32)
- Sponsor's past termination rate
- 11.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 61 (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
- 1267 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 470 (typical: 412.5)
- Drug's FAERS reports marked serious
- 91.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 20.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- eribulin
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
- Trial With Eribulin or Eribulin+ Endocrine Therapy in Locally-recurrent or Metastatic Breast Cancer Patients NCT03795012 · started 2019 · scored riskier than 93% of active trials terminated
- Efficacy and Tolerability of Eribulin Plus Lapatinib in Patients With Metastatic Breast Cancer (E-VITA) NCT01534455 · started 2012 · scored riskier than 88% of active trials terminated
- Eribulin Mesylate in Treating Patients With Previously Treated Metastatic Breast Cancer NCT01908101 · started 2014 · scored riskier than 85% of active trials completed
- Monotherapy With Eribulin In Her2 Negative Metastatic Breast Cancer as a First Line Treatment NCT02061085 · started 2013 · scored riskier than 82% of active trials completed
- Eribulin in HER2 Negative Metastatic BrCa NCT01827787 · started 2013 · scored riskier than 99% 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.