A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi

Model scores of the 29,894 trials active now.

Model score 14% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (927 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 2017-09-21. 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: metastaticcardiacdiseaseadvancedcancer
  Phrases that lowered it: and safetyefficacy andhepatitis viruswomensafety of
• Phase: 3 (lowers risk) · Design
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 13.2% (raises risk) · Sponsor's track record
• Disease area, cancer: Yes (raises risk) · Disease area
• Drug's FAERS reports with a death: 15.7% (lowers risk) · Drug's FDA history
• Has a data monitoring committee: Yes (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 297 (raises risk) · Sponsor's track record
• Sponsor's past trials: 447 (lowers risk) · Sponsor's track record
• Blinding: quadruple (lowers risk) · Design
• Design: parallel (raises risk) · Design
• Disease area, neurology: Yes (raises risk) · Disease area
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Drug's FAERS reports marked serious: 74.0% (lowers risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports in the prior 12 months: 499 (raises risk) · Drug's FDA history
• Maximum age: not given (raises risk) · Who can join
• 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.

• Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor NCT01610284 · started 2012 · scored riskier than 46% of active trials completed
• A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy NCT02340221 · started 2015 · scored riskier than 26% of active trials terminated
• Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3) NCT01942135 · started 2013 · scored riskier than 92% of active trials completed
• Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women NCT01923168 · started 2014 · scored riskier than 79% of active trials completed
• Trial of BKM120/Tamoxifen-combination in Patients With HR-pos, HER2-neg Breast Cancer NCT02404844 · started 2014 · scored riskier than 66% 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.