A Phase 3 Study Comparing Carelizumab Plus Nab-paclitaxel and Apatinib, Carelizumab Plus Nab-paclitaxel, and Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer.

NCT04335006 on ClinicalTrials.gov Phase 3 Jiangsu HengRui Medicine Co., Ltd. (industry) Started 2020-07-14 Terminated

Riskier than 46% of active trials

Model scores of the 29,894 trials active now.

Model score 16% for any early termination, 2% 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 2023-04-14, after 2020-07-14 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 2023-04-14. 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: advancedor metastaticunresectablepdlocally
Phrases that lowered it: breast cancerpatientsrandomisationwithin weeksopen
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 3 (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 103 (lowers risk) · Sponsor's track record
Disease area, cancer: Yes (raises risk) · Disease area
Has a data monitoring committee: Yes (raises risk) · Design
Design: parallel (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Sponsor's past termination rate: 8.9% (raises risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Maximum age: 70 (lowers risk) · Who can join
Drug's FAERS reports with a death: 19.9% (lowers risk) · Drug's FDA history
Number of arms: 3 (lowers risk) · Design
Drug's FAERS reports marked serious: 94.5% (raises risk) · Drug's FDA history
Drug's FAERS reports in the prior 12 months: 9163 (lowers risk) · Drug's FDA history
Drug's FAERS reports before start: 57546 (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: 3 (typical: 2)
Number of arms: 3 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 2 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 70 (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: 90 (typical: 32)
Sponsor's past termination rate: 8.9% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 103 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 3 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 57546 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 9163 (typical: 412.5)
Drug's FAERS reports marked serious: 94.5% (typical: 85.6%)
Drug's FAERS reports with a death: 19.9% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, dermatology
Drugs matched to FDA substances: apatinib, camrelizumab, paclitaxel

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 Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130) NCT02425891 · started 2015 · scored riskier than 44% of active trials completed
A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC) NCT03125902 · started 2017 · scored riskier than 51% of active trials completed
Study of Single Agent Pembrolizumab (MK-3475) Versus Single Agent Chemotherapy for Metastatic Triple Negative Breast Cancer (MK-3475-119/KEYNOTE-119) NCT02555657 · started 2015 · scored riskier than 60% of active trials completed
First-line Nab-paclitaxel Plus Cisplatin Plus Camrelizumab in mTNBC Patients NCT04537286 · started 2020 · scored riskier than 55% of active trials completed
A Trial of SHR-1210 (an Anti-PD-1 Antibody) in Combination With Apatinib in Patients With Advanced TNBC NCT03394287 · started 2018 · scored riskier than 56% 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.