Valproic Acid in Combination With FEC100 for Primary Therapy in Patients With Breast Cancer
Model scores of the 29,894 trials active now.
Model score 35% for any early termination, 12% 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 2011-07-29, after 2008-12-10 start.
Reason given by the sponsor: “efficacy”
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 2011-07-29. 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
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: breast cancerpatientsstagechemotherapynode
Phrases that lowered it: trialsubjectschildrennormaltreatment -
Sponsor's past termination rate: 15.5% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 111 (lowers risk) · Sponsor's track record
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Design: single group (raises risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Maximum age: not given (raises risk) · Who can join
-
Minimum age: 18 (raises risk) · Who can join
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
-
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
-
Blinding: none (raises risk) · Design
-
Number of arms: 1 (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
- 1 (typical: 0)
- Keywords listed
- 3 (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
- academic or other
- Sponsor's past trials
- 103 (typical: 32)
- Sponsor's past termination rate
- 15.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 111 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- none matched
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
- Molecular Signature of Valproic Acid in Breast Cancer With Functional Imaging Assessment - a Pilot NCT01007695 · started 2010 · scored riskier than 96% of active trials terminated
- Bevacizumab, Chemotherapy and Valproic Acid in Advanced Sarcomas NCT01106872 · started 2010 · scored riskier than 83% of active trials completed
- Adjuvant Valproate for High Grade Sarcomas NCT01010958 · started 2009 · scored riskier than 95% of active trials terminated
- Ixabepilone and Vorinostat in Treating Patients With Metastatic Breast Cancer NCT01084057 · started 2010 · scored riskier than 48% of active trials completed
- Study of Valproic Acid (VPA) vs Placebo to Shorten Time of Indwelling Pleural Catheter NCT01900730 · started 2014 · scored riskier than 94% 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.