Use of Metformin to Reduce Cardiac Toxicity in Breast Cancer
Model scores of the 29,894 trials active now.
Model score 18% for any early termination, 18% 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 2018-05-23, after 2014-07-31 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 2018-05-23. 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: metforminbreast cancercardiaculnfraction
Phrases that lowered it: historybeveragesmedicationssignificantper day -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Phase: 2 (raises risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Minimum age: 21 (lowers risk) · Who can join
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Drug's FAERS reports with a death: 11.5% (lowers risk) · Drug's FDA history
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Blinding: none (raises risk) · Design
-
Sponsor's past trials: 1 (raises risk) · Sponsor's track record
-
Primary purpose: prevention (lowers risk) · Design
-
Drug's FAERS reports marked serious: 70.1% (lowers risk) · Drug's FDA history
-
Disease area, dermatology: Yes (raises risk) · Disease area
-
Keywords listed: 7 (lowers risk) · Design
-
Disease area, cardiovascular: Yes (raises risk) · Disease area
-
Number of arms: 2 (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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 7 (typical: 1)
Who can join
- Minimum age
- 21 (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
- 1 (typical: 32)
- Sponsor's past termination rate
- 0% (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
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 118462 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 21447 (typical: 412.5)
- Drug's FAERS reports marked serious
- 70.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, cardiovascular, dermatology
- Drugs matched to FDA substances
- doxorubicin, metformin
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
- A Study of Liposomal Doxorubicin+Docetaxel+Trastuzumab+Metformin in Operable and Locally Advanced HER2 Positive Breast Cancer NCT02488564 · started 2014 · scored riskier than 81% of active trials completed
- Prevention of Cardiac Dysfunction During Adjuvant Breast Cancer Therapy NCT01434134 · started 2011 · scored riskier than 49% of active trials completed
- Neoadjuvant Letrozole Plus Metformin vs Letrozole Plus Placebo for ER-positive Postmenopausal Breast Cancer NCT01589367 · started 2012 · scored riskier than 24% of active trials completed
- Role of Adding Metformin to Neoadjuvant Chemotherapy in Patients With Breast Cancer (METNEO) NCT04170465 · started 2019 · scored riskier than 59% of active trials completed
- The Potential Cardioprotective Effect of Addition of Atorvastatin in Breast Cancer Patients NCT07668076 · started 2022 · scored riskier than 14% 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.