Effects of High Dose Calcitriol in Breast Cancer Patients
Model scores of the 29,894 trials active now.
Model score 30% for any early termination, 19% 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
Completed on 2021-12-31, after 2010-11-30 start.
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 2021-12-31. 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 cancerchronicwomenkidneyserum
Phrases that lowered it: participantssubjectsoral400mg -
Phase: 2 (raises risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Disease area, cancer: Yes (raises risk) · Disease area
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Sponsor's past termination rate: 7.1% (lowers risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports with a death: 16.8% (lowers risk) · Drug's FDA history
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Design: single group (raises risk) · Design
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Primary purpose: prevention (lowers risk) · Design
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Disease area, dermatology: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 43 (lowers risk) · Sponsor's track record
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Blinding: none (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Maximum age: 88 (lowers risk) · Who can join
-
Number of arms: 1 (raises risk) · Design
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Drug's FAERS reports before start: 1803 (raises risk) · Drug's FDA history
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Responsible party: principal investigator (lowers risk) · Design
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Collaborators: 0 (raises risk) · Design
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Drug's FAERS reports marked serious: 85.7% (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
- prevention (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 88 (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
- 84 (typical: 32)
- Sponsor's past termination rate
- 7.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 43 (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
- 1803 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 425 (typical: 412.5)
- Drug's FAERS reports marked serious
- 85.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 16.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- calcitriol
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
- Calcitriol, Physical Activity, and Bone Health in Cancer Survivors NCT00904033 · started 2008 · scored riskier than 58% of active trials completed
- Ph I/II of Vitamin D on Bone Mineral Density & Markers of Bone Resorption NCT00904423 · started 2009 · scored riskier than 91% of active trials terminated
- Safety, Feasibility and Efficacy of Vitamin D Supplementation in Women With Metastatic Breast Cancer (SAFE-D) NCT02186015 · started 2015 · scored riskier than 92% of active trials completed
- Development of Vitamin D as a Therapy for Breast Cancer - Phase 2 NCT00656019 · started 2008 · scored riskier than 96% of active trials completed
- Pilot Study of Bisphosphonates for Breast Cancer NCT02781805 · started 2016 · scored riskier than 26% of active trials terminated
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.