Pilot Study of Cyclobenzaprine for Treatment of Sleep Disturbance in Aromatase Inhibitor-treated Breast Cancer Patients
Model scores of the 29,894 trials active now.
Model score 31% for any early termination, 25% 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
Terminated on 2015-04-30, after 2013-08-31 start.
Reason given by the sponsor: “enrollment”
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 2015-04-30. 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 cancerstagearomatasecarcinomatreated
Phrases that lowered it: once dailymoderatehistorydrugsubjects -
Accepts healthy volunteers: No (raises risk) · Who can join
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Disease area, cancer: Yes (raises risk) · Disease area
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Phase: 2 (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Responsible party: sponsor investigator (raises risk) · Design
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Drug's FAERS reports with a death: 25.9% (raises risk) · Drug's FDA history
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Design: single group (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Has a data monitoring committee: Yes (raises risk) · Design
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Number of arms: 1 (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Disease area, neurology: Yes (raises risk) · Disease area
-
Blinding: none (raises risk) · Design
-
Primary purpose: supportive care (lowers risk) · Design
-
Sponsor's past trials: 0 (raises risk) · Sponsor's track record
-
Collaborators: 1 (raises risk) · Design
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Drug's FAERS reports marked serious: 79.1% (lowers risk) · Drug's FDA history
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
- supportive care (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 2 (typical: 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
- 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
- 7243 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1584 (typical: 412.5)
- Drug's FAERS reports marked serious
- 79.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 25.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, neurology, psychiatry, dermatology
- Drugs matched to FDA substances
- cyclobenzaprine
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
- Bupropion Hydrochloride in Improving Sexual Desire in Women With Breast or Gynecologic Cancer NCT03180294 · started 2017 · scored riskier than 98% of active trials completed
- Management of Insomnia in Breast Cancer Patients NCT01011218 · started 2011 · scored riskier than 56% of active trials completed
- A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause NCT06112756 · started 2023 · scored riskier than 52% of active trials completed
- Fezolinetant for the Improvement of Vasomotor Symptoms in Breast Cancer Patients Taking Endocrine Therapy, VENT Trial NCT06617455 · started 2024 · scored riskier than 78% of active trials terminated
- Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy NCT01091974 · started 2008 · scored riskier than 61% 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.