Safety and Efficacy of BKM120 and Lapatinib in HER2+/PI3K-activated, Trastuzumab-resistant Advanced Breast Cancer

Model scores of the 29,894 trials active now.

Model score 31% 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 (851 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.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2017-10-10. 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: her2trastuzumabmetastatictherapyeffective
  Phrases that lowered it: 20patients whoweeks10clinical
• Phase: 1/2 (raises risk) · Design
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Disease area, cancer: Yes (raises risk) · Disease area
• Design: single group (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 6 (raises risk) · Sponsor's track record
• Has a data monitoring committee: Yes (raises risk) · Design
• Sponsor's past trials: 4 (raises risk) · Sponsor's track record
• Drug's FAERS reports with a death: 12.2% (lowers risk) · Drug's FDA history
• Drug's FAERS reports marked serious: 66.6% (lowers risk) · Drug's FDA history
• Sponsor type: academic or other (raises risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Disease area, dermatology: Yes (raises risk) · Disease area
• Minimum age: 18 (raises risk) · Who can join
• Maximum age: not given (raises risk) · Who can join
• Number of arms: 1 (raises risk) · Design
• Blinding: none (raises risk) · Design
• Drug's FAERS reports before start: 5619 (raises risk) · Drug's FDA history
• 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.

• A Trial of BKM120 (a PI3K Inhibitor) in Patients With Triple Negative Metastatic Breast Cancer NCT01629615 · started 2012 · scored riskier than 99% of active trials completed
• Phase 1b/2 Study of BKM120 Plus Trastuzumab in Patients With HER2-positive Breast Cancer NCT01132664 · started 2010 · scored riskier than 71% of active trials terminated
• Lapatinib Ditosylate and Akt Inhibitor MK2206 in Treating Women With Metastatic Breast Cancer NCT01281163 · started 2011 · scored riskier than 85% of active trials terminated
• A Trial of Gefitinib in Combination With BKM120 in Patients With Advanced Non-Small Cell Lung Cancer, With Enrichment for Patients Whose Tumours Harbour Molecular Alterations of PI3K Pathway and Known to Overexpress EGFR NCT01570296 · started 2011 · scored riskier than 64% of active trials completed
• Capecitabine, Cyclophosphamide, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With HER2-Positive Metastatic Breast Cancer NCT01873833 · started 2013 · scored riskier than 78% 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.