A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation
Model scores of the 29,894 trials active now.
Model score 22% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 34% of the time (35 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 2015-06-30, after 2012-08-31 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 2015-06-30. 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: breast cancerher2paclitaxelmetastatic breastpatients
Phrases that lowered it: measurablescreeningdefineddailypatient has -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 12.8% (raises risk) · Sponsor's track record
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Sponsor's past trials: 423 (lowers risk) · Sponsor's track record
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Blinding: quadruple (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports with a death: 19.5% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Disease area, neurology: Yes (raises risk) · Disease area
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Phase: 2/3 (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Trials the sponsor started in the prior 2 years: 293 (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Collaborators: 0 (raises risk) · Design
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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
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
- 2/3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 8 (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
- industry (typical: academic or other)
- Sponsor's past trials
- 423 (typical: 32)
- Sponsor's past termination rate
- 12.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 293 (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
- 9643 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2330 (typical: 412.5)
- Drug's FAERS reports marked serious
- 95.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 19.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, neurology, dermatology
- Drugs matched to FDA substances
- buparlisib, paclitaxel
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
- NeoPHOEBE: Neoadjuvant Trastuzumab + BKM120 in Combination With Weekly Paclitaxel in HER2-positive Primary Breast Cancer NCT01816594 · started 2013 · scored riskier than 92% of active trials completed
- Safety and Efficacy of BKM120 and Lapatinib in HER2+/PI3K-activated, Trastuzumab-resistant Advanced Breast Cancer NCT01589861 · started 2011 · scored riskier than 98% of active trials terminated
- Trial of BKM120/Tamoxifen-combination in Patients With HR-pos, HER2-neg Breast Cancer NCT02404844 · started 2014 · scored riskier than 66% of active trials completed
- A Trial of Oral BEZ235 and BKM120 in Combination With Paclitaxel With or Without Trastuzumab NCT01285466 · started 2011 · scored riskier than 27% of active trials completed
- Phase Ib/II Trial of BEZ235 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer NCT01495247 · started 2012 · scored riskier than 82% 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.