PD0332991/Paclitaxel in Advanced Breast Cancer
Model scores of the 29,894 trials active now.
Model score 17% for any early termination, 7% 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 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2019-05-31, after 2011-03-31 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2019-05-31. 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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Sponsor's past termination rate: 19.0% (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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: patientsubject hassubject isthe subjectcancer
Phrases that lowered it: breast cancerher2metastatic breasteraminotransferase -
Sponsor type: academic or other (raises risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
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Design: single group (raises risk) · Design
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Drug's FAERS reports with a death: 17.8% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 38 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 94.1% (raises risk) · Drug's FDA history
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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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Disease area, dermatology: Yes (raises risk) · Disease area
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Maximum age: not given (raises risk) · Who can join
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Keywords listed: 9 (lowers risk) · Design
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Collaborators: 0 (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
- 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
- 0
- Keywords listed
- 9 (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
- 21 (typical: 32)
- Sponsor's past termination rate
- 19.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 38 (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
- 6327 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1207 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 17.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- paclitaxel, 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
- Phase 1b Study of PD-0332991 in Combination With T-DM1(Trastuzumab-DM1) NCT01976169 · started 2014 · scored riskier than 52% of active trials completed
- Study of BMN-673 With Carboplatin and Paclitaxel in Patients With Advanced BRCA-mutated Solid Tumor or Triple Negative Metastatic Breast Cancer NCT02358200 · started 2015 · scored riskier than 34% of active trials terminated
- PRS-343 in HER2-Positive Solid Tumors NCT03330561 · started 2017 · scored riskier than 30% of active trials completed
- A Study of BBI608 Administered With Paclitaxel in Adult Patients With Advanced Malignancies NCT01325441 · started 2011 · scored riskier than 54% of active trials completed
- Phase II Lapatinib Plus Nab-Paclitaxel As First And Second Line Therapy In her2+ MBC NCT00709761 · started 2008 · scored riskier than 80% 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.