T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer

Model scores of the 29,894 trials active now.

Model score 39% for any early termination, 23% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (3,728 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 2022-12-22. 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: breast cancerher2metastatictherapypositive breast
  Phrases that lowered it: evaluateefficacysinglearmstudy to
• Phase: 2 (raises risk) · Design
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 13.3% (raises risk) · Sponsor's track record
• Disease area, cancer: Yes (raises risk) · Disease area
• Design: single group (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 44 (lowers risk) · Sponsor's track record
• Has a data monitoring committee: Yes (raises risk) · Design
• Drug's FAERS reports with a death: 10.3% (lowers risk) · Drug's FDA history
• Sponsor type: academic or other (raises risk) · Sponsor's track record
• Drug's FAERS reports marked serious: 50.4% (lowers risk) · Drug's FDA history
• Minimum age: 18 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Disease area, dermatology: Yes (raises risk) · Disease area
• Drug's FAERS reports before start: 26569 (lowers risk) · Drug's FDA history
• Drug's FAERS reports in the prior 12 months: 9429 (lowers risk) · Drug's FDA history
• Maximum age: not given (raises risk) · Who can join
• Blinding: none (raises risk) · Design
• Collaborators: 1 (raises risk) · Design
• Number of arms: 2 (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.

• Palbociclib in Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer NCT03709082 · started 2018 · scored riskier than 90% of active trials terminated
• A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE) NCT01120184 · started 2010 · scored riskier than 18% 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
• Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer NCT02139358 · started 2014 · scored riskier than 92% of active trials completed
• T-DM1 and Non-pegylated Liposomal Doxorubicin in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer NCT02562378 · started 2015 · scored riskier than 58% 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.