A Study of Herceptin (Trastuzumab) in Combination With Xeloda (Capecitabine) in Patients With Metastatic or Recurrent HER2-positive Breast Cancer After First-Line or (Neo)Adjuvant Therapy.

NCT01290718 on ClinicalTrials.gov Phase 2 Hoffmann-La Roche (industry) Started 2011-12-31 Terminated

Riskier than 49% of active trials

Model scores of the 29,894 trials active now.

Model score 16% 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 22% of the time (1,598 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 2012-12-31, after 2011-12-31 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 2012-12-31. 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

Phase: 2 (raises risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: breast cancerher2metastatictrastuzumabpositive breast
Phrases that lowered it: and safetykgefficacy andsafety ofthe efficacy
Has a data monitoring committee: not given (lowers risk) · Design
Disease area, cancer: Yes (raises risk) · Disease area
Sponsor's past termination rate: 10.1% (raises risk) · Sponsor's track record
Design: single group (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Disease area, dermatology: Yes (raises risk) · Disease area
Drug's FAERS reports with a death: 23.9% (raises risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Sponsor's past trials: 476 (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Maximum age: 65 (lowers risk) · Who can join
Blinding: none (raises risk) · Design
Collaborators: 0 (raises risk) · Design
Trials the sponsor started in the prior 2 years: 206 (lowers risk) · Sponsor's track record

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: non randomized (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: not given (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 65 (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: 476 (typical: 32)
Sponsor's past termination rate: 10.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 206 (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: 20324 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 3764 (typical: 412.5)
Drug's FAERS reports marked serious: 93.1% (typical: 85.6%)
Drug's FAERS reports with a death: 23.9% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, dermatology
Drugs matched to FDA substances: capecitabine, 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

A Study of a Combination of Trastuzumab and Capecitabine With or Without Pertuzumab in Patients With HER2-positive Metastatic Breast Cancer (PHEREXA) NCT01026142 · started 2010 · scored riskier than 24% of active trials completed
A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus the Combination of Trastuzumab Plus Docetaxel in Patients With HER2-positive Breast Cancer NCT02144012 · started 2014 · scored riskier than 15% of active trials terminated
Efficacy and Safety of Trastuzumab Emtansine in Chinese Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer NCT03084939 · started 2017 · scored riskier than 27% of active trials completed
A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab) and Xeloda (Capecitabine) in Patients With HER2-Positive Breast Cancer NCT00811135 · started 2008 · scored riskier than 66% of active trials completed
A Study of Pertuzumab and Trastuzumab Subcutaneous (SC) Treatment in Combination With a Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer NCT02019277 · started 2013 · scored riskier than 33% 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.