Study of DS-8201a, an Antibody Drug Conjugate for Advanced Breast Cancer Patients, With Biomarkers Analysis

NCT04132960 on ClinicalTrials.gov Phase 2 UNICANCER (academic or other) Started 2019-10-21 Completed

Riskier than 98% of active trials

Model scores of the 29,894 trials active now.

Model score 31% for any early termination, 12% 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

Completed on 2024-12-26, after 2019-10-21 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 2024-12-26. 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

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: functionwomenbonesubjectadequate
Phrases that lowered it: labelopen14malepatient
Phase: 2 (raises risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 14.8% (raises risk) · Sponsor's track record
Drug's FAERS reports with a death: 50% (raises risk) · Drug's FDA history
Disease area, cancer: Yes (raises risk) · Disease area
Design: single group (raises risk) · Design
Has a data monitoring committee: Yes (raises risk) · Design
Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Sponsor type: academic or other (raises risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Disease area, dermatology: Yes (raises risk) · Disease area
Number of arms: 1 (raises risk) · Design
Collaborators: 1 (raises risk) · Design
Responsible party: sponsor (lowers risk) · Design
Maximum age: not given (raises risk) · Who can join
Trials the sponsor started in the prior 2 years: 20 (lowers risk) · Sponsor's track record
Blinding: none (raises 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: 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: sponsor
Collaborators: 1 (typical: 0)
Keywords listed: 4 (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: academic or other
Sponsor's past trials: 61 (typical: 32)
Sponsor's past termination rate: 14.8% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 20 (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: 4 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 3 (typical: 412.5)
Drug's FAERS reports marked serious: 100% (typical: 85.6%)
Drug's FAERS reports with a death: 50% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, dermatology
Drugs matched to FDA substances: trastuzumab deruxtecan

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

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Ph II Study of Pembrolizumab & Eribulin in Patients With HR+/HER2- MBC Previously Treated With Anthracyclines & Taxanes NCT03222856 · started 2017 · scored riskier than 97% of active trials completed
Ipatasertib + Pertuzumab +Trastuzumab in Advanced HER2+ PI3KCA-mutant Breast Cancer Patients NCT04253561 · started 2020 · scored riskier than 58% of active trials completed
A Study in Patients With Different Types of Advanced Cancer (Solid Tumors) to Test Different Doses of BI 907828 (Brigimadlin) in Combination With BI 754091 (Ezabenlimab) and BI 754111 or BI 907828 (Brigimadlin) in Combination With BI 754091 (Ezabenlimab) NCT03964233 · started 2019 · scored riskier than 25% 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.