Neratinib and Trastuzumab Biosimilar in Patients with HER2 Mutated Advanced Solid Cancers

Model scores of the 29,894 trials active now.

Model score 15% for any early termination, 7% 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.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2024-12-30. 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.

• Phase: 2 (raises risk) · Design
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 13.6% (raises risk) · Sponsor's track record
• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: metastaticher2advancedtrastuzumabcancer
  Phrases that lowered it: patients whoaccordingefficacyevaluatehaving
• Disease area, cancer: Yes (raises risk) · Disease area
• Drug's FAERS reports marked serious: 49.7% (lowers risk) · Drug's FDA history
• Minimum age: 19 (lowers risk) · Who can join
• Design: single group (raises risk) · Design
• Drug's FAERS reports with a death: 14.3% (lowers risk) · Drug's FDA history
• Sponsor type: academic or other (raises risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 8 (raises risk) · Sponsor's track record
• Maximum age: not given (raises risk) · Who can join
• Number of arms: 1 (raises risk) · Design
• Responsible party: principal investigator (lowers risk) · Design
• Collaborators: 1 (raises risk) · Design
• Has a data monitoring committee: No (lowers 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.

• Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer NCT01827267 · started 2013 · scored riskier than 84% of active trials completed
• Neratinib in Treating Older Patients With Stage IV HER2-Positive Breast Cancer NCT02673398 · started 2016 · scored riskier than 98% of active trials completed
• Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations NCT01953926 · started 2013 · scored riskier than 56% of active trials terminated
• Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer NCT00741260 · started 2008 · scored riskier than 74% of active trials completed
• Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib NCT03094052 · started 2018 · 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.