Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer
Model scores of the 29,894 trials active now.
Model score 33% for any early termination, 19% 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
Completed on 2023-10-24, after 2017-02-01 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 2023-10-24. 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: metastaticprotocolwomendefinedprior
Phrases that lowered it: bowelhcvulcerativebreast cancerhepatitis -
Phase: 2 (raises risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Responsible party: sponsor investigator (raises risk) · Design
-
Disease area, cancer: Yes (raises risk) · Disease area
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Drug's FAERS reports with a death: 9.5% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Collaborators: 2 (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Number of arms: 1 (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Disease area, dermatology: Yes (raises risk) · Disease area
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Sponsor's past trials: 0 (raises risk) · Sponsor's track record
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Maximum age: not given (raises risk) · Who can join
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Drug's FAERS reports in the prior 12 months: 7497 (lowers risk) · Drug's FDA history
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 investigator (typical: sponsor)
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 3 (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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
- 17905 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 7497 (typical: 412.5)
- Drug's FAERS reports marked serious
- 61.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 9.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- palbociclib, tamoxifen
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
- BYL719 and Nab-Paclitaxel in Locally Recurrent or Metastatic HER-2 Negative Breast Cancer NCT02379247 · started 2015 · scored riskier than 99% of active trials completed
- Palbociclib and Binimetinib in Advanced Triple Negative Breast Cancer NCT04494958 · started 2020 · scored riskier than 83% of active trials completed
- Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation NCT04432454 · started 2020 · scored riskier than 79% of active trials completed
- PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection NCT03079011 · started 2017 · scored riskier than 54% of active trials completed
- 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
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.