Trial of BDC-1001 +/- Pertuzumab in Subjects With HER2-Positive Metastatic Breast Cancer
Model scores of the 29,894 trials active now.
Model score 20% for any early termination, 6% 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 in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2024-09-25, after 2023-11-30 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 2024-09-25. 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: her2breast cancermetastaticin subjectscardiac
Phrases that lowered it: singlepharmacokineticsopen labelimmunogenicityevaluate -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 10.8% (lowers risk) · Drug's FDA history
-
Design: parallel (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
-
Maximum age: not given (raises risk) · Who can join
-
Disease area, dermatology: Yes (raises risk) · Disease area
-
Drug's FAERS reports marked serious: 85.2% (lowers risk) · Drug's FDA history
-
Blinding: none (raises risk) · Design
-
Collaborators: 1 (raises risk) · Design
-
Sponsor's past trials: 0 (raises risk) · Sponsor's track record
-
Has a data monitoring committee: No (lowers risk) · Design
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
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (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
- 21078 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3106 (typical: 412.5)
- Drug's FAERS reports marked serious
- 85.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 10.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- bdc1001, pertuzumab
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
- DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02] NCT03523585 · started 2018 · scored riskier than 33% of active trials completed
- A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers NCT05091528 · started 2022 · scored riskier than 70% of active trials terminated
- Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer NCT03523572 · started 2018 · scored riskier than 71% of active trials completed
- Study of ISB 1302 (CD3 Bispecific Ab) in HER2-positive Metastatic Breast Cancer NCT03983395 · started 2020 · scored riskier than 95% of active trials terminated
- DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer NCT03505710 · started 2018 · scored riskier than 61% of active trials terminated
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.