Trial to Evaluate Efficacy and Safety of Pembrolizumab and Gemcitabine in HER2-negative ABC
Model scores of the 29,894 trials active now.
Model score 22% for any early termination, 8% 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 (1,198 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2021-07-22, after 2017-06-28 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2021-07-22. 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.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: cellsin situcarcinomagemcitabinetherapy
Phrases that lowered it: trialintendedefficacy andand safetydays -
Sponsor's past termination rate: 19.0% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Drug's FAERS reports with a death: 28.3% (raises risk) · Drug's FDA history
-
Design: single group (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
-
Number of arms: 1 (raises risk) · Design
-
Primary purpose: treatment (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
-
Drug's FAERS reports in the prior 12 months: 6439 (lowers risk) · Drug's FDA history
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Collaborators: 1 (raises risk) · Design
-
Drug's FAERS reports marked serious: 91.6% (raises risk) · Drug's FDA history
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Responsible party: sponsor (lowers risk) · Design
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Blinding: none (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.
The trial
Design
- Phase
- 2
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 21 (typical: 32)
- Sponsor's past termination rate
- 19.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 25637 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 6439 (typical: 412.5)
- Drug's FAERS reports marked serious
- 91.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 28.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- gemcitabine, pembrolizumab
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- A Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast Cancer Patients With Molecular HER2-enriched Intrinsic Subtype (Keyriched-1) NCT03988036 · started 2020 · scored riskier than 83% of active trials completed
- Anti-PD-1 Monoclonal Antibody in Advanced, Trastuzumab-resistant, HER2-positive Breast Cancer NCT02129556 · started 2014 · scored riskier than 86% of active trials completed
- Pembrolizumab + Paclitaxel in HR+/HER2- Non-luminal (by PAM50) Advanced Breast Cancer After CDK4/6 Inhibitor Progression NCT04251169 · started 2020 · scored riskier than 90% of active trials terminated
- Ph II Study of Pembrolizumab & Eribulin in Patients With HR+/HER2- MBC Previously Treated With Anthracyclines & Taxanes NCT03222856 · started 2017 · scored riskier than 97% of active trials completed
- Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab NCT05744375 · started 2023 · scored riskier than 90% 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.