A Phase II Study Comparing The Efficacy Of Venetoclax + Fulvestrant Vs. Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy
Model scores of the 29,894 trials active now.
Model score 17% for any early termination, 4% 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
Terminated on 2021-05-06, after 2018-09-06 start.
Reason given by the sponsor: “business”
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 2021-05-06. 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: metastaticbowellocally advancedcarcinomacancer
Phrases that lowered it: participantsparticipantwomenthe efficacydrug -
Phase: 2 (raises risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Sponsor's past termination rate: 9.1% (raises risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 133 (lowers risk) · Sponsor's track record
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Design: parallel (raises risk) · Design
-
Drug's FAERS reports with a death: 19.0% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Sponsor's past trials: 1033 (raises risk) · Sponsor's track record
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Disease area, dermatology: Yes (raises risk) · Disease area
-
Drug's FAERS reports marked serious: 78.4% (lowers risk) · Drug's FDA history
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Maximum age: not given (raises risk) · Who can join
-
Collaborators: 0 (raises risk) · Design
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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
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (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
- 1033 (typical: 32)
- Sponsor's past termination rate
- 9.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 133 (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
- 13433 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 5482 (typical: 412.5)
- Drug's FAERS reports marked serious
- 78.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 19.0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- fulvestrant, venetoclax
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 Efficacy of Ribociclib After Progression on CDK4/6 Inhibition in Patients With HR+ HER2- Advanced Breast Cancer NCT02632045 · started 2016 · scored riskier than 99% of active trials completed
- Fulvestrant With or Without Bortezomib in Patients With Inoperable Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer NCT01142401 · started 2010 · scored riskier than 31% of active trials completed
- Dose Escalation and Expansion Study of GSK525762 in Combination With Fulvestrant in Participants With Hormone Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced or Metastatic Breast Cancer NCT02964507 · started 2019 · scored riskier than 27% of active trials terminated
- Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation NCT04432454 · started 2020 · scored riskier than 79% of active trials completed
- A Study of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer NCT02384239 · started 2015 · scored riskier than 95% 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.