Study to Compare the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Combination Chemotherapy in Premenopausal or Perimenopausal Patients With Advanced or Metastatic Breast Cancer
Model scores of the 29,894 trials active now.
Model score 22% 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 22% of the time (1,598 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-05-10, after 2019-02-25 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 2023-05-10. 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: metastaticchemotherapycancerintervaldisease
Phrases that lowered it: breastlocallaboratorypositiverange -
Sponsor's past termination rate: 15.0% (raises risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Trials the sponsor started in the prior 2 years: 163 (lowers risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
-
Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 18.2% (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
-
Sponsor's past trials: 1198 (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports in the prior 12 months: 45082 (lowers risk) · Drug's FDA history
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Drug's FAERS reports before start: 221749 (lowers risk) · Drug's FDA history
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Disease area, dermatology: Yes (raises risk) · Disease area
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Drug's FAERS reports marked serious: 83.8% (lowers risk) · Drug's FDA history
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Maximum age: 59 (lowers risk) · Who can join
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Drugs with FDA adverse-event history: 9 (raises risk) · Drug's FDA history
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Responsible party: sponsor (lowers 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
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 15 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 59 (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
- 1198 (typical: 32)
- Sponsor's past termination rate
- 15.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 163 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 9 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 221749 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 45082 (typical: 412.5)
- Drug's FAERS reports marked serious
- 83.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 18.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- anastrozole, capecitabine, docetaxel, gemcitabine, goserelin, letrozole, paclitaxel, ribociclib
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 of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer NCT03822468 · started 2019 · scored riskier than 77% of active trials completed
- Efficacy and Safety of Ribociclib in Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer. NCT03671330 · started 2018 · scored riskier than 76% of active trials completed
- Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer NCT01958021 · started 2013 · scored riskier than 74% of active trials completed
- Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer. NCT02422615 · started 2015 · scored riskier than 41% of active trials completed
- Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant NCT03439046 · started 2018 · scored riskier than 41% of active trials terminated
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.