Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC)
Model scores of the 29,894 trials active now.
Model score 19% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 23% of the time (1,629 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2025-09-25, after 2017-02-09 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 2025-09-25. 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: cancerchemotherapytumortumorsstage
Phrases that lowered it: maletolerabilitydosesfirst dosesafety -
Sponsor's past termination rate: 40% (raises risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Drug's FAERS reports with a death: 12.9% (lowers risk) · Drug's FDA history
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Drug's FAERS reports in the prior 12 months: 43818 (lowers risk) · Drug's FDA history
-
Drug's FAERS reports before start: 249388 (lowers risk) · Drug's FDA history
-
Primary purpose: treatment (raises risk) · Design
-
Keywords listed: 6 (lowers risk) · Design
-
Maximum age: not given (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 76.1% (lowers risk) · Drug's FDA history
-
Minimum age: not given (raises risk) · Who can join
-
Drugs with FDA adverse-event history: 3 (lowers risk) · Drug's FDA history
-
Collaborators: 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
- 1 (typical: 2)
- Number of arms
- 2
- Allocation
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- not given (typical: 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
- 20 (typical: 32)
- Sponsor's past termination rate
- 40% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 9 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 249388 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 43818 (typical: 412.5)
- Drug's FAERS reports marked serious
- 76.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 12.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- cyclophosphamide, indomethacin, omeprazole
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
- Ixabepilone and Cyclophosphamide as Neoadjuvant Therapy in HER-2 Negative Breast Cancer NCT00866905 · started 2009 · scored riskier than 80% of active trials completed
- Neo-Adjuvant Study in Triple Negative Breast Cancer Patients NCT01097642 · started 2008 · scored riskier than 99% of active trials completed
- Adjuvant Treatment for High-risk Triple Negative Breast Cancer Patients With the Anti-PD-l1 Antibody Avelumab NCT02926196 · started 2016 · scored riskier than 22% of active trials completed
- Trial of Ixabepilone in Patients With HER-2 Negative Metastatic Breast Cancer (HIT) NCT00790894 · started 2008 · scored riskier than 89% of active trials terminated
- A Randomized Trial of Ixempra Versus Taxol in Adjuvant Therapy of Triple Negative Breast Cancer NCT00789581 · started 2008 · scored riskier than 60% 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.