Phase III to Evaluate Patient´s Preference of Subcutaneous Trastuzumab vs Intravenous in HER2+ Advanced Breast Cancer
Model scores of the 29,894 trials active now.
Model score 19% for any early termination, 15% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 20% of the time (607 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 2018-04-30, after 2013-09-18 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 2018-04-30. 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: least monthspatientcancerpriorentry
Phrases that lowered it: historyopenseverephase iiievaluate -
Sponsor's past termination rate: 25% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 3 (lowers 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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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports with a death: 19.5% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
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Has a data monitoring committee: No (lowers risk) · Design
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Sex: female (lowers risk) · Who can join
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Responsible party: sponsor (lowers risk) · Design
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Drug's FAERS reports before start: 10321 (lowers risk) · Drug's FDA history
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Sponsor's past trials: 12 (lowers risk) · Sponsor's track record
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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 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
- 12 (typical: 32)
- Sponsor's past termination rate
- 25% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (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
- 10321 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3109 (typical: 412.5)
- Drug's FAERS reports marked serious
- 95.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 19.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- 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
- A Study to Investigate the Tolerability of Subcutaneous (SC) Trastuzumab Administration in Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Early Breast Cancer (eBC) Using Either a Single-Use Injection Device or Manual Administration NCT02194166 · started 2014 · scored riskier than 17% of active trials completed
- A Study of Subcutaneous At Home Administration of Trastuzumab (Herceptin) in Participants With Human Epidermal Growth Factor Receptor 2-positive (HER2+) Early Breast Cancer (eBC) NCT01926886 · started 2013 · scored riskier than 30% of active trials completed
- A Study to Assess Preference for Subcutaneous Trastuzumab Treatment in Participants With Human Epidermal Growth Factor Receptor (HER)2-Positive Metastatic Breast Cancer Responding to First-Line Intravenous Trastuzumab for at Least 3 Years NCT01810393 · started 2013 · scored riskier than 18% of active trials completed
- A Study of the Safety of Subcutaneously Administered Trastuzumab (Herceptin) in Participants With Early and Locally Advanced Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer NCT01940497 · started 2013 · scored riskier than 26% of active trials completed
- A Study of Participant Satisfaction and Safety With Subcutaneously Administered Trastuzumab (Herceptin) in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer NCT01964391 · started 2014 · scored riskier than 31% 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.