Neo-Adjuvant Abemaciclib With Fulvestrant in Patients With ER/PR +HER Negative Breast Cancer

NCT04305236 on ClinicalTrials.gov Phase 2 University of California, Irvine (academic or other) Started 2020-07-23 Terminated

Riskier than 96% of active trials

Model scores of the 29,894 trials active now.

Model score 29% for any early termination, 20% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (3,728 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Terminated on 2022-02-16, after 2020-07-23 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 2022-02-16. 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: breast cancerpatients mustdefinedacuteher2
Phrases that lowered it: resistanceendocrinecolitisviralclinical trial
Phase: 2 (raises risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 13.4% (raises risk) · Sponsor's track record
Disease area, cancer: Yes (raises risk) · Disease area
Drug's FAERS reports with a death: 11.9% (lowers risk) · Drug's FDA history
Has a data monitoring committee: Yes (raises risk) · Design
Design: single group (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Trials the sponsor started in the prior 2 years: 26 (lowers risk) · Sponsor's track record
Sponsor's past trials: 127 (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Number of arms: 1 (raises risk) · Design
Disease area, dermatology: Yes (raises risk) · Disease area
Responsible party: principal investigator (lowers risk) · Design
Maximum age: not given (raises risk) · Who can join
Collaborators: 1 (raises risk) · Design
Blinding: none (raises risk) · Design
Drug's FAERS reports marked serious: 67.6% (lowers risk) · Drug's FDA history

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: 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: academic or other
Sponsor's past trials: 127 (typical: 32)
Sponsor's past termination rate: 13.4% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 26 (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: 17322 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 5144 (typical: 412.5)
Drug's FAERS reports marked serious: 67.6% (typical: 85.6%)
Drug's FAERS reports with a death: 11.9% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, dermatology
Drugs matched to FDA substances: abemaciclib, fulvestrant

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

This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer NCT03099174 · started 2017 · scored riskier than 30% of active trials completed
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
HR+/HER2- Advanced Breast Cancer and Endocrine Resistance NCT03322215 · started 2017 · scored riskier than 82% of active trials terminated
Evaluation of Lasofoxifene Versus Fulvestrant in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation NCT03781063 · started 2019 · scored riskier than 68% of active trials completed
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

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.