Neo-Adjuvant Treatment With Palbociclib: Effect on Ki67 and Apoptosis Before, During and After Treatment
Model scores of the 29,894 trials active now.
Model score 26% for any early termination, 18% 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 2019-11-30, after 2015-05-31 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 2019-11-30. 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: metastaticcancerqtctherapyher2
Phrases that lowered it: kgeffectjudgedinvestigatordrugs -
Sponsor's past termination rate: 50% (raises risk) · Sponsor's track record
-
Primary purpose: other (lowers risk) · Design
-
Phase: 2 (raises risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Drug's FAERS reports with a death: 18.8% (lowers risk) · Drug's FDA history
-
Design: single group (raises risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Blinding: none (raises risk) · Design
-
Disease area, dermatology: Yes (raises risk) · Disease area
-
Drugs with FDA adverse-event history: 4 (lowers risk) · Drug's FDA history
-
Maximum age: not given (raises risk) · Who can join
-
Keywords listed: 6 (lowers risk) · Design
-
Number of arms: 1 (raises risk) · Design
-
Collaborators: 0 (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 1 (raises 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
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- other (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 6 (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
- 2 (typical: 32)
- Sponsor's past termination rate
- 50% (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
- 4 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 19300 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3640 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 18.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- fulvestrant, palbociclib, pertuzumab, 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 Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery NCT01864746 · started 2013 · scored riskier than 76% of active trials completed
- Neoadjuvant Letrozole and Palbociclib in Patients With Stage II-IIIB Breast Cancer, HR+, HER2 - NCT03819010 · started 2019 · scored riskier than 81% of active trials completed
- Trial of Eribulin/Cyclophosphamide or Docetaxel/Cyclophosphamide as Neoadjuvant Therapy in Locally Advanced HER2-Negative Breast Cancer NCT01527487 · started 2012 · scored riskier than 94% of active trials completed
- De-escalation Adjuvant Chemo in HER2+/ER-/node-neg Early BC Patients Who Achieved PCR After Neoadjuvant Chemo & Dual HER2 Blockade NCT04675827 · started 2022 · scored riskier than 80% of active trials terminated
- Neoadjuvant Ixabepilone/Carboplatin/Trastuzumab in HER2-Positive Locally Advanced Breast Cancer NCT00821886 · started 2009 · scored riskier than 90% 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.