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

Model scores of the 29,894 trials active now.

Model score 16% for any early termination, 3% 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 2019-04-19. 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.

• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: metastaticadvancedcancerlocallymeasurable
  Phrases that lowered it: breast cancerher2and safetyefficacy andsafety of
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 3 (lowers risk) · Design
• Sponsor's past termination rate: 12.8% (raises risk) · Sponsor's track record
• Has a data monitoring committee: Yes (raises risk) · Design
• Sponsor's past trials: 423 (lowers risk) · Sponsor's track record
• Blinding: quadruple (lowers risk) · Design
• Drug's FAERS reports with a death: 14.1% (lowers risk) · Drug's FDA history
• Disease area, cancer: Yes (raises risk) · Disease area
• Design: parallel (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Drug's FAERS reports marked serious: 73.7% (lowers risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports before start: 1516 (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 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 NCT01633060 · started 2012 · scored riskier than 37% 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
• QUILT-2.015: A Study of AMG 479 With Exemestane or Fulvestrant in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer NCT00626106 · started 2008 · scored riskier than 94% of active trials completed
• Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor NCT00754325 · started 2008 · scored riskier than 33% 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

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.