SAFIR-PI3K A Phase II Randomized Maintenance Trial Comparing Alpelisib and Fulvestrant Versus Chemotherapy in PIK3CA Mutated Advanced Breast Cancer

Model scores of the 29,894 trials active now.

Model score 30% for any early termination, 15% 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 2022-11-18. 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.

• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: breast cancerher2patient hasmgrandomization
  Phrases that lowered it: accordinglinedrugshypersensitivitydiseases
• Phase: 2 (raises risk) · Design
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 14.8% (raises risk) · Sponsor's track record
• Disease area, cancer: Yes (raises risk) · Disease area
• Has a data monitoring committee: Yes (raises risk) · Design
• Design: parallel (raises risk) · Design
• Disease area, dermatology: Yes (raises risk) · Disease area
• Drug's FAERS reports marked serious: 68.2% (lowers risk) · Drug's FDA history
• Sponsor type: academic or other (raises risk) · Sponsor's track record
• Drug's FAERS reports with a death: 11.9% (lowers risk) · Drug's FDA history
• Minimum age: 18 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Disease area, neurology: Yes (raises risk) · Disease area
• Trials the sponsor started in the prior 2 years: 20 (lowers risk) · Sponsor's track record
• Maximum age: not given (raises risk) · Who can join
• Blinding: none (raises risk) · Design
• Number of arms: 2 (raises risk) · Design
• Responsible party: sponsor (lowers risk) · Design
• Collaborators: 0 (raises risk) · Design
• Drug's FAERS reports before start: 7325 (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.

• Open-Label Study Evaluating the Safety and Tolerability of LJM716, BYL719 and Trastuzumab in Patients With Metastatic HER2+ Breast Cancer NCT02167854 · started 2014 · scored riskier than 23% of active trials completed
• The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC NCT04338399 · started 2020 · scored riskier than 68% of active trials completed
• Ipatasertib + Pertuzumab +Trastuzumab in Advanced HER2+ PI3KCA-mutant Breast Cancer Patients NCT04253561 · started 2020 · scored riskier than 58% of active trials completed
• Olaparib+Trastuzumab in HER2[+],Breast Cancer Susceptibility Gene (BRCA) Mutated Advanced Breast Cancer NCT03931551 · started 2019 · scored riskier than 71% of active trials terminated
• Phase Ib Study of Alpelisib With Cisplatin in Patients With HPV+ Solid Tumor Malignancies NCT02620839 · started 2016 · scored riskier than 44% of active trials terminated

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.