Study of Amcenestrant (SAR439859) Versus Tamoxifen for Patients With Hormone Receptor-positive (HR+) Early Breast Cancer, Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity

Model scores of the 29,894 trials active now.

Model score 13% 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 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 2022-10-13. 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: cancerstagepriorrandomizationbowel
  Phrases that lowered it: periodweeksbreast cancertabletssequence
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 3 (lowers risk) · Design
• Collaborators: 3 (lowers risk) · Design
• Sponsor's past termination rate: 11.4% (raises risk) · Sponsor's track record
• Has a data monitoring committee: Yes (raises risk) · Design
• Drug's FAERS reports with a death: 8.1% (lowers risk) · Drug's FDA history
• Disease area, cancer: Yes (raises risk) · Disease area
• Trials the sponsor started in the prior 2 years: 82 (lowers risk) · Sponsor's track record
• Design: parallel (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Blinding: quadruple (lowers risk) · Design
• Minimum age: 18 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Sponsor's past trials: 1019 (raises risk) · Sponsor's track record
• Drug's FAERS reports marked serious: 80.7% (lowers risk) · Drug's FDA history
• Disease area, dermatology: Yes (raises risk) · Disease area

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 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer NCT04191382 · started 2020 · scored riskier than 54% of active trials terminated
• Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer NCT04059484 · started 2019 · scored riskier than 51% of active trials terminated
• Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer NCT04478266 · started 2020 · scored riskier than 30% of active trials terminated
• Fulvestrant With or Without AZD6244 in Treating Patients With Advanced Breast Cancer That Progressed After Aromatase Inhibitor Therapy NCT01160718 · started 2010 · scored riskier than 98% of active trials completed
• A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer NCT04752332 · started 2021 · scored riskier than 21% 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.