A Multi-Center Study of Lapatinib in Patients With Trastuzumab-refractory Metastatic Breast Cancer
Model scores of the 29,894 trials active now.
Model score 25% 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 16% of the time (1,198 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2020-05-31, after 2015-01-09 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 2020-05-31. 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
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: carcinoma ofsquamousfunctionthe skincell carcinoma
Phrases that lowered it: the efficacylinecombinationnormalconsent form -
Sponsor's past termination rate: 1.4% (lowers risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 89 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 29.7% (raises risk) · Drug's FDA history
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Design: single group (raises risk) · Design
-
Responsible party: principal investigator (lowers risk) · Design
-
Sponsor's past trials: 70 (lowers risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Number of arms: 1 (raises risk) · Design
-
Blinding: none (raises risk) · Design
-
Maximum age: 65 (lowers risk) · Who can join
-
Drug's FAERS reports marked serious: 88.3% (lowers risk) · Drug's FDA history
-
Drug's FAERS reports before start: 40737 (lowers risk) · Drug's FDA history
-
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
- 18
- Maximum age
- 65 (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
- 70 (typical: 32)
- Sponsor's past termination rate
- 1.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 89 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 40737 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 4639 (typical: 412.5)
- Drug's FAERS reports marked serious
- 88.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 29.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- capecitabine, lapatinib, 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
- Chemotherapy and Lapatinib or Trastuzumab in Treating Women With HER2/Neu-Positive Metastatic Breast Cancer NCT00667251 · started 2008 · scored riskier than 40% of active trials completed
- A Study of Trastuzumab-Mcc-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer NCT00679211 · started 2008 · scored riskier than 61% of active trials completed
- T-DM1 and Non-pegylated Liposomal Doxorubicin in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer NCT02562378 · started 2015 · scored riskier than 58% of active trials completed
- Efficacy and Safety of Trastuzumab Emtansine in Chinese Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer NCT03084939 · started 2017 · scored riskier than 27% of active trials completed
- Study of the Pharmacokinetics and Safety of Trastuzumab Emtansine in Chinese Participants With Locally Advanced Inoperable or Metastatic HER2+ Breast Cancer NCT03153163 · started 2017 · scored riskier than 30% 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.