Radiation omission in patients with clinically node-negative breast cancer undergoing lumpectomy (ROSALIE).
Bibliographic record
Abstract
TPS628 Background: Currently, the standard of care for patients undergoing neoadjuvant chemotherapy (NAC) and breast conserving surgery (BCS) is adjuvant radiation (RT). However, high rates of pathologic complete response (pCR) after NAC have raised questions regarding the necessity of WBRT in these cases. A meta-analysis of 9 German NAC trials demonstrated a 5-year locoregional recurrence (LRR) of only 4% in patients with pCR who underwent BCS with radiation therapy. Data from two large National Surgical Adjuvant Breast and Bowel Project (NSABP) neoadjuvant trials (B.18 and B.27) demonstrated a local recurrence risk of 5.1% at 10 years (2.5% at 5 years) in patients >50 years with node negative breast cancer who had a pCR and were treated with BCS and RT. With such low rates of recurrence, we postulated that the absolute benefit that RT can offer is limited. Radiation therapy is not without side effects, which include both short-term and long-term toxicity. As such, a trial of de-escalation of RT is warranted. Methods: This study is a prospective, multi-center, single arm cohort study of omission of WBRT following BCS in patients with a pCR following NAC. Eligible and consenting female patients with newly diagnosed T1-3 node negative breast cancer age >50 years with no clinical evidence of distant metastatic disease, who have been treated with NAC, BCS and axillary staging surgery with final pathology demonstrating a pCR (ypT0N0) will be enrolled to the study and followed. Negative lymph node involvement at initial presentation must be documented by imaging (US or MRI), fine needle aspiration (FNA) or core needle biopsy. Marker clip must have been placed in the tumour bed prior to or during neoadjuvant chemotherapy when the tumour can still be identified. Study participants will not receive adjuvant RT, the current standard of care. Study participants will be followed and assessed for local recurrence, regional recurrence, distant recurrence, DFS and OS. Any additional breast cancer treatments received by the participant for the first recurrence event including repeat BCS, mastectomy, additional systemic therapy and radiation therapy (RT) will be documented. The primary outcome is ipsilateral breast tumour recurrence (IBTR) at median 5-year follow-up. A local recurrence of 5% without RT was felt to be acceptable. Based on a postulated 5-year IBTR risk of 3.0%, 4 years of accrual plus an additional 3 years of follow-up, a 90% two-sided CI for a postulated LR rate of 3.0% at 5 years would have an upper bound of <5% with 300 patients. To account for a 5% potential loss to follow-up and 10% receiving RT contrary to protocol, a sample size of 352 patients will be required. The trial opened in March 2024. Clinical trial information: NCT05866458 .
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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) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| 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 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".