Denosumab for Breast Cancer With Bone Mets
Model scores of the 29,894 trials active now.
Model score 26% for any early termination, 20% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (3,728 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2018-10-10, after 2015-02-09 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
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2018-10-10. 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
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: cancercarcinomametastaticchemotherapyradiation
Phrases that lowered it: aminotransferasebreast cancermalelesionsproducts -
Sponsor's past termination rate: 28.5% (raises risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Disease area, cancer: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 149 (lowers risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 17.5% (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
-
Disease area, dermatology: Yes (raises risk) · Disease area
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Drug's FAERS reports in the prior 12 months: 12081 (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
-
Drug's FAERS reports before start: 27465 (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 64.5% (lowers risk) · Drug's FDA history
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Blinding: none (raises risk) · Design
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Collaborators: 1 (raises risk) · Design
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Sponsor's past trials: 519 (lowers risk) · Sponsor's track record
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Number of arms: 1 (raises risk) · Design
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Responsible party: sponsor (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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 8 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (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
- 519 (typical: 32)
- Sponsor's past termination rate
- 28.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 149 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 27465 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 12081 (typical: 412.5)
- Drug's FAERS reports marked serious
- 64.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 17.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- denosumab
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
- Denosumab in Treating Patients With ER and/or PR Positive, HER2 Negative Metastatic Breast Cancer With Bone Metastases and Detectable Circulating Tumor Cells NCT03070002 · started 2017 · scored riskier than 94% of active trials terminated
- Pilot Study to Evaluate the Impact of Denosumab on Disseminated Tumor Cells (DTC) in Patients With Early Stage Breast Cancer NCT01545648 · started 2012 · scored riskier than 97% of active trials terminated
- Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE) NCT01077154 · started 2010 · scored riskier than 51% of active trials terminated
- A Study to Evaluate Denosumab in Young Patients With Primary Breast Cancer NCT01864798 · started 2013 · scored riskier than 83% of active trials terminated
- Denosumab in Treating Patients With Recurrent or Refractory Osteosarcoma NCT02470091 · started 2015 · scored riskier than 71% 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.