A pragmatic, multicenter, randomized trial comparing morning versus evening dosing of adjuvant endocrine therapy (REaCT-CHRONO Study)
Bibliographic record
Abstract
The time of day of administration (chronotherapy) of certain medications can affect both their toxicity and efficacy. In this pragmatic, multicenter trial, women starting adjuvant endocrine therapy (ET) for hormone receptor-positive early-stage breast cancer were randomized (1:1) to either morning or evening administration. The primary endpoint was endocrine toxicity/tolerability measured by the change in total Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) score from baseline to 12-weeks. Secondary endpoints included: endocrine toxicity/tolerability and quality of life (FACT-ES and FACT-B) from baseline to 4, 8, 12, and 52 weeks, non-persistence or non-adherence, and patient preference for timing of ET. Between June 30, 2021, and March 18, 2022, 245 eligible participants were randomized to either morning (122/245, 49.8%) or evening ET (123/245, 50.2%). In the overall population, there was no statistical difference in the change in total FACT-ES score from baseline to 12 weeks (p = 0.086). There were no statistically significant differences for any of the secondary endpoints between the two groups. The study provides evidence for the enthusiasm of patients and investigators to take part in chronotherapy studies. Additional prospective studies should be performed to assess how the timing of ET affects survival outcomes to ensure optimal patient care. Trial Registration: ClinicalTrials.gov, NCT04864405.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.007 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.010 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".