A Phase Ib Dose Escalation Study of the Combination of LEE011 With Letrozole and Dose Expansion of LEE011 With Hormonal Therapy for the Treatment of Pre-(With Goserelin) and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

Model scores of the 29,894 trials active now.

Model score 12% 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 5% of the time (4,470 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 2022-09-29. 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: 1 (lowers risk) · Design
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: cancermetastaticadvancedtherapymalignancy
  Phrases that lowered it: patient hasdosejapaneseescalationpatients
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 13.4% (raises risk) · Sponsor's track record
• Drug's FAERS reports with a death: 13.5% (lowers risk) · Drug's FDA history
• Sponsor's past trials: 739 (raises risk) · Sponsor's track record
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Design: parallel (raises risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Has a data monitoring committee: No (lowers risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Maximum age: not given (raises risk) · Who can join
• Drug's FAERS reports marked serious: 86.5% (lowers risk) · Drug's FDA history
• Number of arms: 3 (lowers risk) · Design
• Responsible party: sponsor (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.

• Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer NCT02088684 · started 2014 · scored riskier than 28% of active trials completed
• Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer NCT02278120 · started 2014 · scored riskier than 30% of active trials completed
• Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer NCT01857193 · started 2013 · scored riskier than 65% of active trials completed
• Phase I/Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers NCT02734615 · started 2016 · scored riskier than 32% of active trials terminated
• Efficacy and Safety of Ribociclib in Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer. NCT03671330 · started 2018 · scored riskier than 76% 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.