A Study of Abemaciclib (LY2835219) With and Without Food in Participants With Metastatic Breast Cancer
Model scores of the 29,894 trials active now.
Model score 22% for any early termination, 7% 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
Completed on 2023-03-09, after 2018-11-28 start.
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 2023-03-09. 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 cancerher2metastatic breastventricularreceiving
Phrases that lowered it: participants withclinical studycooperativegroupeastern -
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: 6.5% (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 142 (lowers 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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Number of arms: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 5.8% (lowers risk) · Drug's FDA history
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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
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Primary purpose: treatment (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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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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Collaborators: 0 (raises risk) · Design
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Drug's FAERS reports marked serious: 37.0% (lowers risk) · Drug's FDA history
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Responsible party: sponsor (lowers risk) · Design
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Blinding: none (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
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (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
- 1205 (typical: 32)
- Sponsor's past termination rate
- 6.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 142 (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
- 756 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 727 (typical: 412.5)
- Drug's FAERS reports marked serious
- 37.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 5.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- abemaciclib
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
- Study Evaluating Abemaciclib + Aromatase Inhibitors in HR+, HER2- Advanced Breast Cancer Patients (HERMIONE-7) NCT04227327 · started 2020 · scored riskier than 97% of active trials terminated
- A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer NCT02675231 · started 2016 · scored riskier than 59% of active trials completed
- A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread NCT02102490 · started 2014 · scored riskier than 35% of active trials completed
- A Study of Abemaciclib in Participants With Cancer That is Advanced or Has Spread to Another Part(s) of the Body NCT02688088 · started 2016 · scored riskier than 31% of active trials completed
- A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer NCT04514159 · started 2020 · scored riskier than 45% 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.