The PROMISE Study: Duavee in Women With DCIS
Model scores of the 29,894 trials active now.
Model score 28% for any early termination, 11% 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
Completed on 2024-06-19, after 2017-01-31 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 2024-06-19. 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: determinecancerpatients muststudy ispatient
Phrases that lowered it: healthystudy willdrugeffect ofthe study -
Sponsor's past termination rate: 23.2% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Collaborators: 4 (lowers risk) · Design
-
Disease area, cancer: Yes (raises risk) · Disease area
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Primary purpose: prevention (lowers risk) · Design
-
Blinding: quadruple (lowers risk) · Design
-
Sponsor's past trials: 367 (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 100 (lowers risk) · Sponsor's track record
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Maximum age: 79 (lowers risk) · Who can join
-
Minimum age: 18 (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 74.5% (lowers risk) · Drug's FDA history
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Drug's FAERS reports with a death: 3.2% (raises risk) · Drug's FDA history
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
- prevention (typical: treatment)
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 4 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 79 (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
- 367 (typical: 32)
- Sponsor's past termination rate
- 23.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 100 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 56662 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3568 (typical: 412.5)
- Drug's FAERS reports marked serious
- 74.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 3.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer
- Drugs matched to FDA substances
- bazedoxifene, estrogens, estrogens conjugated
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
- Testing an Active Form of Tamoxifen (4-hydroxytamoxifen) Delivered Through Breast Skin to Control Ductal Carcinoma in Situ (DCIS) of the Breast NCT02993159 · started 2017 · scored riskier than 83% of active trials completed
- Biological and Clinical Effects of Palbociclib With Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Breast Cancer NCT03628066 · started 2018 · scored riskier than 96% of active trials completed
- Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10% NCT05659563 · started 2023 · scored riskier than 95% of active trials completed
- Oral Tamoxifen vs. TamGel vs. Control in Women With Atypical Hyperplasia, Lobular Carcinoma In Situ, or Increased Breast Cancer Risk NCT04570956 · started 2021 · scored riskier than 88% of active trials terminated
- A Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Palbociclib With Letrozole as Neoadjuvant Therapy in Post-Menopausal Women With Estrogen-Receptor Positive Primary Breast Cancer NCT02296801 · started 2015 · scored riskier than 99% 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.