Randomized Phase 2 Study of Atezolizumab and Entinostat in Patients With aTN Breast Cancer With Phase 1b Lead In
Model scores of the 29,894 trials active now.
Model score 28% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 29% of the time (655 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2021-03-31, after 2016-05-31 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 2021-03-31. 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: smallcancerpriorradiationtherapy
Phrases that lowered it: participantparticipantsfirst dosefemaledrug -
Sponsor's past termination rate: 42.9% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1/2 (raises risk) · Design
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Blinding: quadruple (lowers risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Design: parallel (raises risk) · Design
-
Drug's FAERS reports with a death: 24.6% (raises risk) · Drug's FDA history
-
Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Drug's FAERS reports marked serious: 97.5% (raises risk) · Drug's FDA history
-
Collaborators: 1 (raises risk) · Design
-
Maximum age: not given (raises risk) · Who can join
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
- 1/2 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 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
- 7 (typical: 32)
- Sponsor's past termination rate
- 42.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (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
- 122 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 92 (typical: 412.5)
- Drug's FAERS reports marked serious
- 97.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 24.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- atezolizumab, entinostat
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
- A Pilot Study of the Combination of Entinostat With Capecitabine in High Risk Breast Cancer After Neo-adjuvant Therapy NCT03473639 · started 2019 · scored riskier than 54% of active trials completed
- Entinostat Neuroendocrine (NE) Tumor NCT03211988 · started 2017 · scored riskier than 99% of active trials terminated
- Ph1b/2 Dose-Escalation Study of Entinostat With Pembrolizumab in Non-small Cell Lung Cancer (NSCLC) With Expansion Cohorts in NSCLC, Melanoma, and Colorectal Cancer (CRC) NCT02437136 · started 2015 · scored riskier than 69% of active trials completed
- Testing the Addition of an Anti-cancer Drug, Entinostat, to the Usual Chemotherapy and Immunotherapy Treatment (Atezolizumab, Carboplatin and Etoposide) for Previously Untreated Aggressive Lung Cancer That Has Spread NCT04631029 · started 2021 · scored riskier than 78% of active trials completed
- Atezolizumab + Pertuzumab + Trastuzumab In CNS Mets In BC NCT03417544 · started 2018 · scored riskier than 92% 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.