A Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin® in HER2+ Early Breast Cancer Patients

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 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 2022-01-13. 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: carcinomacellsitustagemetastatic
  Phrases that lowered it: patientspharmacokineticsmmhgthe aimaim of
• Phase: 3 (lowers risk) · Design
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
• Disease area, cancer: Yes (raises risk) · Disease area
• Has a data monitoring committee: Yes (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
• Design: parallel (raises risk) · Design
• Blinding: triple (raises risk) · Design
• Drug's FAERS reports with a death: 20.2% (lowers risk) · Drug's FDA history
• Minimum age: 18 (raises risk) · Who can join
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Drug's FAERS reports before start: 135453 (lowers risk) · Drug's FDA history
• Primary purpose: treatment (raises risk) · Design
• Drugs with FDA adverse-event history: 4 (lowers risk) · Drug's FDA history
• Drug's FAERS reports in the prior 12 months: 29952 (lowers risk) · Drug's FDA history
• Sponsor's past trials: 0 (raises risk) · Sponsor's track record
• Keywords listed: 15 (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 Study to Compare the Effect of SB3 and Herceptin® in Women With HER2 Positive Breast Cancer NCT02149524 · started 2014 · scored riskier than 63% of active trials completed
• A Randomized Study of TH Versus THL in First Line Treatment of HER2-positive Metastatic Breast Cancer NCT01526369 · started 2012 · scored riskier than 96% of active trials completed
• Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer NCT06038539 · started 2025 · scored riskier than 38% of active trials terminated
• Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer NCT03433313 · started 2018 · scored riskier than 35% of active trials completed
• Clinical Trial to Assess Pharmacokinetic Parameters and Safety of NNG-TMAB (Trastuzumab) on Recurrent or Metastatic Breast Cancer Patients. NCT05301530 · started 2019 · scored riskier than 20% 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.