Safety and Efficacy of Exemestane Plus Dasatinib Versus Placebo for Advanced ER+ Breast Cancer
Model scores of the 29,894 trials active now.
Model score 32% for any early termination, 7% 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
Completed on 2012-12-31, after 2009-02-28 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 2012-12-31. 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: ventricularheartcancerpriorsubjects
Phrases that lowered it: breast cancerestrogenintended tomonths beforehormonal -
Phase: 2 (raises risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 6.1% (lowers risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 106 (lowers risk) · Sponsor's track record
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Drug's FAERS reports with a death: 11.7% (lowers risk) · Drug's FDA history
-
Design: parallel (raises risk) · Design
-
Disease area, dermatology: Yes (raises risk) · Disease area
-
Sponsor's past trials: 165 (lowers risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Drug's FAERS reports marked serious: 94.9% (raises risk) · Drug's FDA history
-
Minimum age: 18 (raises risk) · Who can join
-
Maximum age: not given (raises risk) · Who can join
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Number of arms: 2 (raises risk) · Design
-
Responsible party: sponsor (lowers risk) · Design
-
Blinding: double (raises risk) · Design
-
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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 165 (typical: 32)
- Sponsor's past termination rate
- 6.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 106 (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
- 1478 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 452 (typical: 412.5)
- Drug's FAERS reports marked serious
- 94.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- dasatinib, exemestane
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
- Study Evaluating Bosutinib-Exemestane Combination Vs Exemestane Alone in Post Menopausal Women With Breast Cancer NCT00793546 · started 2009 · scored riskier than 86% of active trials terminated
- Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer NCT02007512 · started 2013 · scored riskier than 88% of active trials completed
- Hormone Receptor Positive Metastatic Breast Cancer (HR+ mBC) BIIB021 Plus Aromasin Schedule Finding NCT01004081 · started 2009 · scored riskier than 98% of active trials completed
- Phase II Short-term Adjuvant Therapy and Biomarker Studies With Targeted Agents in Women With Estrogen Receptor Negative Breast Cancer NCT01471106 · started 2014 · scored riskier than 94% of active trials completed
- BI 836845 in Estrogen Receptor Positive Metastatic Breast Cancer NCT02123823 · started 2014 · scored riskier than 19% 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.