Pembrolizumab + Paclitaxel in HR+/HER2- Non-luminal (by PAM50) Advanced Breast Cancer After CDK4/6 Inhibitor Progression
Model scores of the 29,894 trials active now.
Model score 25% for any early termination, 10% 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.
How it ended
Terminated on 2024-04-30, after 2020-07-21 start.
Reason given by the sponsor: “enrollment”
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 2024-04-30. 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: definedimagingcarcinomapriorgrowth
Phrases that lowered it: dosemaledayperiodvaccine -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 5 (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Design: single group (raises risk) · Design
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Sponsor's past trials: 7 (raises risk) · Sponsor's track record
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Number of arms: 1 (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
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Disease area, dermatology: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 21.8% (raises risk) · Drug's FDA history
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Drug's FAERS reports before start: 80582 (lowers risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 15931 (lowers risk) · Drug's FDA history
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Collaborators: 1 (raises 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
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 7 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 5 (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
- 80582 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 15931 (typical: 412.5)
- Drug's FAERS reports marked serious
- 91.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 21.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- paclitaxel, 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
- Pilot Study of Paclitaxel Plus Pembrolizumab in Metastatic HER2-Negative Breast Cancer NCT03018080 · started 2017 · scored riskier than 90% of active trials completed
- Trial to Evaluate Efficacy and Safety of Pembrolizumab and Gemcitabine in HER2-negative ABC NCT03025880 · started 2017 · scored riskier than 80% of active trials completed
- Carboplatin +/- Nivolumab in Metastatic Triple Negative Breast Cancer NCT03414684 · started 2018 · scored riskier than 87% of active trials completed
- Study Of Single-dose Cyclophosphamide +Pembrolizumab In Patients With Metastatic Triple Negative Breast Cancer NCT02768701 · started 2016 · scored riskier than 92% of active trials completed
- Phase 2 Study of Pembrolizumab+Carboplatin in Breast Related Cancer Antigens-related Metastatic Breast Cancer (PEMBRACA) NCT03732391 · started 2018 · scored riskier than 93% 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.