Intermittent High-Dose Lapatinib in Tandem With Capecitabine for HER2 Overexpressed/Amplified Metastatic Breast Cancer With Central Nervous System (CNS) Metastases
Model scores of the 29,894 trials active now.
Model score 15% 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 2021-01-22, after 2016-01-06 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 2021-01-22. 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: brainpriorchronicenrollmentheart
Phrases that lowered it: dosedexamethasonemgweeksdaily -
Phase: 1 (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 4.4% (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 109 (lowers risk) · Sponsor's track record
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Has a data monitoring committee: not given (lowers risk) · Design
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Sponsor's past trials: 411 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 28.9% (raises risk) · Drug's FDA history
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Design: single group (raises risk) · Design
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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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Collaborators: 2 (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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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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Number of arms: 1 (raises risk) · Design
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Responsible party: sponsor (lowers risk) · Design
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Maximum age: not given (raises risk) · Who can join
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Drug's FAERS reports marked serious: 86.7% (raises 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
- 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
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 4 (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
- 411 (typical: 32)
- Sponsor's past termination rate
- 4.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 109 (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
- 42441 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4491 (typical: 412.5)
- Drug's FAERS reports marked serious
- 86.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 28.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- capecitabine, lapatinib
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
- Capecitabine, Cyclophosphamide, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With HER2-Positive Metastatic Breast Cancer NCT01873833 · started 2013 · scored riskier than 78% of active trials terminated
- LBH589 in Combination With Capecitabine Plus/Minus (±) Lapatinib in Breast Cancer Patients NCT00632489 · started 2008 · scored riskier than 72% of active trials completed
- Lapatinib in Women With Metastatic Breast Cancer Who Have Failed Prior Antihormone Therapy NCT00759642 · started 2009 · scored riskier than 99% of active trials terminated
- Study of BKM120 or BYL719 and Capecitabine in Patients With Metastatic Breast Cancer NCT01300962 · started 2011 · scored riskier than 75% of active trials completed
- Tesetaxel Plus Reduced Dose of Capecitabine in Patients With HER2 Negative, HR Positive, LA/MBC NCT03858972 · started 2019 · scored riskier than 81% 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.