Phase 2 Study of Standard Chemotherapy With Trastuzumab, Plus or Minus Pertuzumab, for Pre-treated Metastatic Breast Cancer
Model scores of the 29,894 trials active now.
Model score 27% 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 22% of the time (1,598 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
Terminated on 2022-01-31, after 2014-12-31 start.
Reason given by the sponsor: “business”
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 2022-01-31. 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: metastaticcancerradiationfunctionchemotherapy
Phrases that lowered it: solidbreast cancerclinicaltrial20 -
Phase: 2 (raises risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Disease area, cancer: Yes (raises risk) · Disease area
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 27.7% (raises risk) · Drug's FDA history
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Sponsor's past termination rate: 7.1% (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 4 (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Blinding: none (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Collaborators: 1 (raises risk) · Design
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Disease area, dermatology: Yes (raises risk) · Disease area
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Drug's FAERS reports marked serious: 95.8% (raises risk) · Drug's FDA history
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Responsible party: sponsor (lowers risk) · Design
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Sponsor's past trials: 14 (raises 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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 3 (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
- 14 (typical: 32)
- Sponsor's past termination rate
- 7.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 4 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 6 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 74052 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 12384 (typical: 412.5)
- Drug's FAERS reports marked serious
- 95.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 27.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- capecitabine, docetaxel, paclitaxel, pertuzumab, trastuzumab, vinorelbine
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
- Vinorelbine With Trastuzumab Emtansine in Pre-Treated HER2-Positive Metastatic Breast Cancer NCT02658084 · started 2017 · scored riskier than 97% of active trials terminated
- A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer NCT00567190 · started 2008 · scored riskier than 42% of active trials completed
- 1303GCC: Trastuzmab & Pertuzumab With Hormonal Therapy or Chemotherapy in Women Aged 60 and Over. NCT02000596 · started 2014 · scored riskier than 91% of active trials terminated
- A Study of the Efficacy and Safety of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) vs. Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease NCT00679341 · started 2008 · scored riskier than 85% of active trials completed
- The Synergism Or Long Duration (SOLD) Study NCT00593697 · started 2008 · scored riskier than 51% 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.