HKI-272 for HER2-Positive Breast Cancer and Brain Metastases
Model scores of the 29,894 trials active now.
Model score 28% for any early termination, 11% 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
Completed on 2024-04-19, after 2012-02-29 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 2024-04-19. 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: breast cancerher2chemotherapymritrastuzumab
Phrases that lowered it: participantsparticipantcopiesmultipleallergic -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 11.4% (raises risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Collaborators: 2 (lowers risk) · Design
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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 37 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 28.8% (raises risk) · Drug's FDA history
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Sponsor's past trials: 140 (lowers risk) · Sponsor's track record
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Number of arms: 4 (lowers risk) · Design
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Blinding: none (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Responsible party: principal investigator (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: 15077 (raises risk) · Drug's FDA history
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
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 2 (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
- 140 (typical: 32)
- Sponsor's past termination rate
- 11.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 37 (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
- 15077 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2755 (typical: 412.5)
- Drug's FAERS reports marked serious
- 93.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 28.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- ado trastuzumab emtansine, capecitabine, neratinib
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 Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer NCT02614794 · started 2016 · scored riskier than 98% of active trials completed
- A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer NCT04539938 · started 2020 · scored riskier than 74% of active trials completed
- Efficacy and Safety of the Combination of Trastuzumab Plus TUCAtinib Plus viNorelbine in Patients With HER2-positive Non-resectable Locally Advanced or Metastatic Breast Cancer NCT05583110 · started 2023 · scored riskier than 80% of active trials terminated
- Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer NCT03289039 · started 2017 · scored riskier than 97% of active trials terminated
- Lapatinib and WBRT for Patients With Brain Metastases From Lung or Breast Tumors NCT01218529 · started 2010 · scored riskier than 99% 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.