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Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.

NCT02437318 on ClinicalTrials.gov Phase 3 Novartis Pharmaceuticals (industry) Started 2015-07-23 Completed
Riskier than 60% of active trials
this trial: 18% 0% 36%

Model scores of the 29,894 trials active now.

Model score 18% 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

Completed on 2023-06-09, after 2015-07-23 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

0% 7% 14% 21% 28% 0123456 yr completed 24% terminated 13%

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2023-06-09. 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
triple (typical: none)
Has a data monitoring committee
Yes (typical: 56% yes)
Responsible party
sponsor
Collaborators
0
Keywords listed
14 (typical: 1)

Who can join

Minimum age
18
Maximum age
100 (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
794 (typical: 32)
Sponsor's past termination rate
14.4% (typical: 9.9%)
Trials the sponsor started in the prior 2 years
242 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history
2 (typical: 1)
Drug has FAERS history
Yes (typical: 64% yes)
Drug's FAERS reports before start
2658 (typical: 2148)
Drug's FAERS reports in the prior 12 months
401 (typical: 412.5)
Drug's FAERS reports marked serious
74.4% (typical: 85.6%)
Drug's FAERS reports with a death
13.3% (typical: 15.9%)

Disease area and drugs

Disease areas
cancer, dermatology, endocrine
Drugs matched to FDA substances
alpelisib, fulvestrant

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.