OCTS-08 MRI SCREENING FOR BRAIN METASTASES AMONG PATIENTS WITH TRIPLE NEGATIVE OR HER2+ STAGE II OR III BREAST CANCER: A MULTI-CENTRE, SINGLE ARM PHASE II CLINICAL TRIAL – THE INSIGHT TRIAL
Bibliographic record
Abstract
Abstract BACKGROUND The incidence of asymptomatic brain metastasis (BrM) among patients with early-stage HER2+ and Triple Negative (TN) breast cancer (BC) is not well understood. Our goal is to determine the proportion of patients with stage II or III HER2+ or TN BC who have asymptomatic BrM identified on a screening contrast-enhanced MRI of the brain in a prospective clinical trial. METHODS A phase II, single-arm, multi-centre, conducted in Ontario, Canada (NCT06247449). One hundred patients (50 with HER2+ and 50 with TN disease) are being recruited over 24-months. Key inclusion criteria: i) age ≥18; ii) HER2+ or TN BC (2018 ASCO/CAP guidelines); iii) stage II or III disease. Key exclusion criteria: i) symptoms suggestive of BrM which would otherwise require imaging; ii) known asymptomatic BrM; iii) pregnancy. Patients will undergo a contrast-enhanced MRI of the brain (or contrast-enhanced CT if MRI is not possible), blood collection for ctDNA analysis, and completion of the Testing Morbidities Index (TMI) questionnaire within 4 weeks of recruitment. Interventions must be performed within 12 months of original BC diagnosis and within 6 weeks of starting post-operative adjuvant therapy. Co-primary endpoints: i) the proportion of eligible patients with stage II or III HER2+ BC who have asymptomatic BrM, and ii) the proportion of eligible patients with stage II or III TN BC who have asymptomatic BrM. Secondary endpoints: the proportion of patients who are approached about the study who agree to enroll; patients’ acceptability of the brain imaging as evaluated by the TMI; and the proportion of patients who have subsequent brain MRIs after the initial trial MRI. The association of baseline clinical, tissue-based, and ctDNA based biomarkers with the presence of asymptomatic BrM at initial staging and with future development of BrM at 1-year, 2-year and 3-years (captured by chart review) will also be assessed.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
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".