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 distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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 teacher head, 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".