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Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer

NCT06038539 on ClinicalTrials.gov Phase 3 Biocon Biologics UK Ltd (industry) Started 2025-01-06 Terminated
Riskier than 38% of active trials
this trial: 15% 0% 36%

Model scores of the 29,894 trials active now.

Model score 15% 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 10% of the time (1,463 trials).

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

How it ended

Terminated on 2025-12-23, after 2025-01-06 start.

Reason given by the sponsor: “other”

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

0% 11% 23% 34% 46% 0123456 yr completed 40% terminated 14%

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2025-12-23. 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

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
6 (typical: 1)

Who can join

Minimum age
18
Maximum age
99 (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
3 (typical: 32)
Sponsor's past termination rate
0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years
0 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history
4 (typical: 1)
Drug has FAERS history
Yes (typical: 64% yes)
Drug's FAERS reports before start
294777 (typical: 2148)
Drug's FAERS reports in the prior 12 months
34716 (typical: 412.5)
Drug's FAERS reports marked serious
85.3% (typical: 85.6%)
Drug's FAERS reports with a death
13.1% (typical: 15.9%)

Disease area and drugs

Disease areas
none of the 14 tracked areas
Drugs matched to FDA substances
carboplatin, docetaxel, pertuzumab, trastuzumab

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

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.