HER2HEART-US: Prevention of Cardiotoxicity in Breast Cancer Patients Receiving HER2-directed Therapy
Model scores of the 29,894 trials active now.
Model score 28% for any early termination, 9% 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 in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2026-05-07, after 2025-04-16 start.
Reason given by the sponsor: “efficacy”
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 2026-05-07. 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: her2breast cancertreatingconcurrentstage
Phrases that lowered it: participantsand safetyefficacy andasthmasafety of -
Sponsor's past termination rate: 20.7% (raises risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Design: factorial (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Disease area, cancer: Yes (raises risk) · Disease area
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Primary purpose: prevention (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 132 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Sponsor's past trials: 1009 (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports with a death: 10.0% (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 67.0% (lowers risk) · Drug's FDA history
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Number of arms: 4 (lowers risk) · Design
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Disease area, dermatology: Yes (raises risk) · Disease area
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Drug's FAERS reports before start: 194960 (lowers risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 17080 (lowers risk) · Drug's FDA history
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Blinding: none (raises risk) · Design
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Disease area, cardiovascular: Yes (raises risk) · Disease area
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Maximum age: not given (raises risk) · Who can join
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Collaborators: 0 (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
- 4 (typical: 2)
- Allocation
- randomized
- Design
- factorial (typical: parallel)
- Primary purpose
- prevention (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 4 (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
- 1009 (typical: 32)
- Sponsor's past termination rate
- 20.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 132 (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
- 194960 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 17080 (typical: 412.5)
- Drug's FAERS reports marked serious
- 67.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, cardiovascular, dermatology
- Drugs matched to FDA substances
- carvedilol, empagliflozin
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 Phase II Study of Neoadjuvant Trastuzumab+Docetaxel+NPLD+/-Bevacizumab in Her2-pos. Early Breast Cancer NCT01367028 · started 2011 · scored riskier than 91% of active trials completed
- Paclitaxel With Trastuzumab and Lapatinib in HER2-Positive Early Stage Breast Cancer NCT01827163 · started 2013 · scored riskier than 58% of active trials completed
- Treating Breast Cancer Patients Undergoing Trastuzumab Treatment With Carvedilol to Reduce Incidence of Heart Failure NCT03879629 · started 2019 · scored riskier than 94% of active trials terminated
- A Randomized Study of TH Versus THL in First Line Treatment of HER2-positive Metastatic Breast Cancer NCT01526369 · started 2012 · scored riskier than 96% of active trials completed
- A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer NCT01160211 · started 2011 · scored riskier than 61% 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.