Phase II Study of T-DX in HER2-positive Breast Cancer Brain Metastases
Model scores of the 29,894 trials active now.
Model score 26% for any early termination, 17% 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 2023-05-01, after 2020-07-28 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 2023-05-01. 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 cancerher2ventriculartrastuzumabpulmonary
Phrases that lowered it: arthritisrheumatoidasthmainadequateclinical -
Phase: 2 (raises risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Maximum age: 100 (lowers risk) · Who can join
-
Drug's FAERS reports marked serious: 48.1% (lowers risk) · Drug's FDA history
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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: 60 (lowers risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Sponsor's past termination rate: 7.7% (raises risk) · Sponsor's track record
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Sponsor's past trials: 339 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 12.2% (lowers risk) · Drug's FDA history
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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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Responsible party: principal investigator (lowers risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Collaborators: 1 (raises risk) · Design
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Number of arms: 1 (raises risk) · Design
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Blinding: none (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
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 100 (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
- 339 (typical: 32)
- Sponsor's past termination rate
- 7.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 60 (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
- 156 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 154 (typical: 412.5)
- Drug's FAERS reports marked serious
- 48.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 12.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- trastuzumab deruxtecan
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
- Evaluation of Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer NCT02213042 · started 2014 · scored riskier than 92% of active trials terminated
- A Study of U3-1402 (Patritumab Deruxtecan) in Subjects With Metastatic Breast Cancer NCT04699630 · started 2021 · scored riskier than 77% of active trials completed
- Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab NCT05744375 · started 2023 · scored riskier than 90% of active trials terminated
- Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC) NCT04644237 · started 2021 · scored riskier than 65% of active trials completed
- DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease NCT04420598 · started 2020 · scored riskier than 92% 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.