Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer
Model scores of the 29,894 trials active now.
Model score 28% for any early termination, 9% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 23% of the time (1,629 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-03-20, after 2017-08-18 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 2024-03-20. 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: patients musttherapycancerradiationmacular
Phrases that lowered it: participantstrialopen labelrangefemale -
Sponsor's past termination rate: 44.9% (raises risk) · Sponsor's track record
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Phase: 1 (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Drug's FAERS reports marked serious: 52.2% (lowers risk) · Drug's FDA history
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Disease area, cancer: Yes (raises risk) · Disease area
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Design: sequential (lowers risk) · Design
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Drug's FAERS reports with a death: 9.8% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports in the prior 12 months: 9728 (lowers risk) · Drug's FDA history
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Disease area, dermatology: Yes (raises risk) · Disease area
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Responsible party: principal investigator (lowers risk) · Design
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Maximum age: not given (raises risk) · Who can join
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Collaborators: 1 (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
- 1 (typical: 2)
- Number of arms
- 2
- Allocation
- non randomized (typical: randomized)
- Design
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 4 (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
- 69 (typical: 32)
- Sponsor's past termination rate
- 44.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 11 (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
- 19692 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 9728 (typical: 412.5)
- Drug's FAERS reports marked serious
- 52.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- erdafitinib, fulvestrant, palbociclib
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 of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer NCT02384239 · started 2015 · scored riskier than 95% of active trials completed
- Endocrine Therapy + OSI-906 With or Without Erlotinib for Hormone-Sensitive Metastatic Breast Cancer NCT01205685 · started 2010 · scored riskier than 99% of active trials terminated
- Palbociclib in Molecularly Characterized ER-positive/HER2-negative Metastatic Breast Cancer NCT02536742 · started 2016 · scored riskier than 99% of active trials completed
- Rogaratinib, Palbociclib y Fulvestrant in Patients With Breast Cancer. NCT04483505 · started 2020 · scored riskier than 16% of active trials completed
- Onapristone and Fulvestrant for ER+ HER2- Metastatic Breast Cancer After Endocrine Therapy and CDK4/6 Inhibitors (The SMILE Study) NCT04738292 · started 2021 · scored riskier than 97% 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.