Phase III Study of Vinflunine Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer
Model scores of the 29,894 trials active now.
Model score 14% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (927 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 2017-07-31, after 2013-09-30 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 2017-07-31. 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: equalcarcinomasurgerywomen ofuln
Phrases that lowered it: breast cancerrandomisedto compareopen labelthe trial -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Drug's FAERS reports with a death: 35.2% (raises risk) · Drug's FDA history
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Minimum age: 21 (lowers risk) · Who can join
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Phase: 3 (lowers risk) · Design
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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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Trials the sponsor started in the prior 2 years: 15 (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Maximum age: 80 (lowers risk) · Who can join
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor's past trials: 18 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 94.3% (raises risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 5934 (lowers risk) · Drug's FDA history
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Disease area, dermatology: Yes (raises risk) · Disease area
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
- 3 (typical: 2)
- Number of arms
- 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
- 21 (typical: 18)
- Maximum age
- 80 (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 18 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 15 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 23518 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 5934 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 35.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- capecitabine, vinflunine
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
- Metronomic Treatment With Daily Oral Vinorelbine as First-line Chemotherapy in Patients With Advanced/Metastatic Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Breast Cancer NCT03007992 · started 2016 · scored riskier than 99% of active trials completed
- Breast Cancer Study: Paclitaxel Versus Paclitaxel Plus Sorafenib in Second- or Third-line Treatment NCT01320111 · started 2010 · scored riskier than 94% of active trials completed
- Capecitabine and Bevacizumab ± Vinorelbine in Metastatic Breast Cancer NCT00868634 · started 2009 · scored riskier than 30% of active trials completed
- MEtronomic TrEatment Option in Advanced bReast cAncer NCT02954055 · started 2017 · scored riskier than 97% of active trials completed
- Olaparib +/- Cediranib or Chemotherapy in Patients With Platinum-resistant Ovarian Cancer NCT03117933 · started 2017 · scored riskier than 67% 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.