A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer

NCT04752332 on ClinicalTrials.gov Phase 3 Eli Lilly and Company (industry) Started 2021-05-10 Terminated

Riskier than 21% of active trials

Model scores of the 29,894 trials active now.

Model score 11% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (927 trials).

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

How it ended

Terminated on 2024-06-26, after 2021-05-10 start.

Reason given by the sponsor: “enrollment”

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 2024-06-26. 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

Phase: 3 (lowers risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: cancertumorsurgerydiseasetherapy
Phrases that lowered it: breast cancerher2trastuzumabcycleshave received
Trials the sponsor started in the prior 2 years: 171 (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: 8.7% (lowers risk) · Drug's FDA history
Disease area, cancer: Yes (raises risk) · Disease area
Sponsor's past termination rate: 7.1% (lowers risk) · Sponsor's track record
Has a data monitoring committee: Yes (raises risk) · Design
Drug's FAERS reports marked serious: 46.2% (lowers risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Sponsor's past trials: 1403 (raises risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Blinding: double (raises risk) · Design
Disease area, dermatology: Yes (raises risk) · Disease area
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: 3 (typical: 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: 0 (typical: 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: 1403 (typical: 32)
Sponsor's past termination rate: 7.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 171 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 4743 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 1504 (typical: 412.5)
Drug's FAERS reports marked serious: 46.2% (typical: 85.6%)
Drug's FAERS reports with a death: 8.7% (typical: 15.9%)

Disease area and drugs

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

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

Neo-Adjuvant Abemaciclib With Fulvestrant in Patients With ER/PR +HER Negative Breast Cancer NCT04305236 · started 2020 · scored riskier than 96% of active trials terminated
Study of Amcenestrant (SAR439859) Versus Tamoxifen for Patients With Hormone Receptor-positive (HR+) Early Breast Cancer, Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity NCT05128773 · started 2022 · scored riskier than 31% of active trials terminated
A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer NCT01966471 · started 2014 · scored riskier than 18% of active trials completed
Anastrozole and Letrozole After Surgery for the Treatment of Stage I-III Breast Cancer NCT04294225 · started 2020 · scored riskier than 86% of active trials completed
CDK4/6-inhibitor or Chemotherapy, in Combination with ENDOcrine Therapy, for Advanced Breast Cancer / KENDO NCT03227328 · started 2017 · 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.