Neoadjuvant Nab-PTX and Trastuzumab for ER Negative and HER2 Positive Breast Cancer
Model scores of the 29,894 trials active now.
Model score 17% 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 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
Terminated on 2018-11-30, after 2015-11-30 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 2018-11-30. 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 cancerher2trastuzumabheartdl
Phrases that lowered it: and safetyefficacy andhcvevaluate thethe efficacy -
Minimum age: 20 (lowers risk) · Who can join
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
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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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Responsible party: principal investigator (lowers risk) · Design
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Maximum age: 70 (lowers risk) · Who can join
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Has a data monitoring committee: Yes (raises risk) · Design
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Number of arms: 1 (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Sponsor's past trials: 1 (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 95.2% (raises risk) · Drug's FDA history
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Disease area, dermatology: Yes (raises risk) · Disease area
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Drug's FAERS reports before start: 37859 (lowers risk) · Drug's FDA history
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Blinding: none (raises 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
- 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
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 20 (typical: 18)
- Maximum age
- 70 (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
- 1 (typical: 32)
- Sponsor's past termination rate
- 0% (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
- 37859 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 7686 (typical: 412.5)
- Drug's FAERS reports marked serious
- 95.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 21.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- paclitaxel, trastuzumab
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
- Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab NCT01432223 · started 2011 · scored riskier than 37% of active trials completed
- Neoadjuvant Treatment With Nab-paclitaxel for Patients With Stage II and III Luminal Breast Cancer NCT01565499 · started 2012 · scored riskier than 89% of active trials completed
- Neoadjuvant 5-fluorouracil, Epirubicin and Cyclophosphamide (FEC) Followed by Weekly Paclitaxel and Trastuzumab in Her2 Positive Breast Cancer NCT01340430 · started 2011 · scored riskier than 72% of active trials completed
- Evaluate Trastuzumab Plus Standard Chemotherapy Given Before Surgery in Breast Cancer Patients With Low HER 2 Expression NCT00944047 · started 2009 · scored riskier than 97% of active trials completed
- Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery NCT00770809 · started 2009 · scored riskier than 37% 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.