Molecular Mechanisms of Resistance and Sensitivity to Palbociclib Re-challenge in ER+ mBC
Model scores of the 29,894 trials active now.
Model score 34% for any early termination, 15% 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 2020-10-27, 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 2020-10-27. 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
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: breast cancerher2receptormetastaticstudy entry
Phrases that lowered it: qtcobjectivetabletsdoseclinical -
Phase: 2 (raises risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Disease area, cancer: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 6 (raises risk) · Sponsor's track record
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
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Design: single group (raises risk) · Design
-
Sponsor's past trials: 2 (raises risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Number of arms: 1 (raises risk) · Design
-
Drug's FAERS reports with a death: 8.7% (lowers risk) · Drug's FDA history
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Maximum age: not given (raises risk) · Who can join
-
Has a data monitoring committee: No (lowers risk) · Design
-
Blinding: none (raises risk) · Design
-
Disease area, dermatology: Yes (raises risk) · Disease area
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Collaborators: 0 (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 7244 (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
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (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
- 2 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 6 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 12301 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 7244 (typical: 412.5)
- Drug's FAERS reports marked serious
- 45.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- 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
- PALbociclib Rechallenge in horMone Receptor-posItive/HER2- Negative Advanced Breast Cancer (PALMIRA) NCT03809988 · started 2019 · scored riskier than 71% of active trials completed
- Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant NCT02894398 · started 2016 · scored riskier than 99% of active trials completed
- HR+/HER2- Advanced Breast Cancer and Endocrine Resistance NCT03322215 · started 2017 · scored riskier than 82% of active trials terminated
- 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
- Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Aromatase Inhibitors NCT02028507 · started 2014 · scored riskier than 86% 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.