Palbociclib in Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer

Model scores of the 29,894 trials active now.

Model score 26% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 18% of the time (283 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 2021-02-03. 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: subject haspriorphase iimetastaticdetermine
  Phrases that lowered it: dailydosecombinationdaysafety
• Phase: 1/2 (raises risk) · Design
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 10.5% (raises risk) · Sponsor's track record
• Number of arms: 4 (lowers risk) · Design
• Drug's FAERS reports with a death: 9.7% (lowers risk) · Drug's FDA history
• Design: parallel (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Has a data monitoring committee: Yes (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 52 (lowers risk) · Sponsor's track record
• Sponsor type: academic or other (raises risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Blinding: none (raises risk) · Design
• Drug's FAERS reports before start: 45095 (lowers risk) · Drug's FDA history
• Drug's FAERS reports in the prior 12 months: 13976 (lowers risk) · Drug's FDA history
• Maximum age: not given (raises risk) · Who can join
• Responsible party: principal investigator (lowers risk) · Design
• Collaborators: 1 (raises risk) · Design
• Drug's FAERS reports marked serious: 61.7% (lowers risk) · Drug's FDA history

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.

• T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer NCT03530696 · started 2018 · scored riskier than 99% of active trials completed
• Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Advanced Breast Cancer NCT02491983 · started 2015 · scored riskier than 97% of active trials completed
• A Phase Ib/II Study of BEZ235 and Trastuzumab in Patients With HER2-positive Breast Cancer Who Failed Prior to Trastuzumab NCT01471847 · started 2012 · scored riskier than 69% of active trials completed
• A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer NCT03471663 · started 2018 · scored riskier than 32% of active trials completed
• A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer NCT02684032 · started 2016 · scored riskier than 32% 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.