NeoMET Study in Neoadjuvant Treatment of Breast Cancer

NCT01929811 on ClinicalTrials.gov Phase 2 Shanghai Jiao Tong University School of Medicine (academic or other) Started 2013-10-31 Terminated

Riskier than 21% of active trials

Model scores of the 29,894 trials active now.

Model score 11% for any early termination, 8% 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 (1,198 trials).

Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

How it ended

Terminated on 2020-06-30, after 2013-10-31 start.

Reason given by the sponsor: “enrollment”

The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

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 2020-06-30. 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

Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: metforminstagecancerchemotherapypatients must
Phrases that lowered it: severefunctionpulmonarybreastdisorder
Phase: 2 (raises risk) · Design
Trials the sponsor started in the prior 2 years: 26 (lowers risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Responsible party: principal investigator (lowers risk) · Design
Drug's FAERS reports with a death: 10.0% (lowers risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Maximum age: 70 (lowers risk) · Who can join
Minimum age: 18 (raises risk) · Who can join
Has a data monitoring committee: Yes (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Sponsor's past trials: 31 (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports in the prior 12 months: 16617 (lowers risk) · Drug's FDA history
Number of arms: 2 (raises risk) · Design
Blinding: none (raises risk) · Design
Drug's FAERS reports before start: 94933 (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: 2
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: principal investigator (typical: sponsor)
Collaborators: 0
Keywords listed: 0 (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: academic or other
Sponsor's past trials: 31 (typical: 32)
Sponsor's past termination rate: 0% (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: 3 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 94933 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 16617 (typical: 412.5)
Drug's FAERS reports marked serious: 69.1% (typical: 85.6%)
Drug's FAERS reports with a death: 10.0% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: docetaxel, epirubicin, metformin

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 Trial of Standard Chemotherapy With Metformin (vs Placebo) in Women With Metastatic Breast Cancer NCT01310231 · started 2011 · scored riskier than 93% of active trials completed
A Study of Liposomal Doxorubicin+Docetaxel+Trastuzumab+Metformin in Operable and Locally Advanced HER2 Positive Breast Cancer NCT02488564 · started 2014 · scored riskier than 81% of active trials completed
Neoadjuvant Letrozole Plus Metformin vs Letrozole Plus Placebo for ER-positive Postmenopausal Breast Cancer NCT01589367 · started 2012 · scored riskier than 24% of active trials completed
Neoadjuvant Chemotherapy With Nab-paclitaxel in Women With HER2-negative High-risk Breast Cancer NCT01822314 · started 2013 · scored riskier than 43% of active trials completed
Role of Adding Metformin to Neoadjuvant Chemotherapy in Patients With Breast Cancer (METNEO) NCT04170465 · started 2019 · scored riskier than 59% 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.