The Breast Cancer Weight Loss (BWEL) trial: Randomized phase III trial evaluating the role of weight loss in adjuvant treatment of overweight and obese women with early-stage breast cancer (Alliance A011401).
Bibliographic record
Abstract
TPS598 Background: Obesity is a growing health problem in the Unites States and around the world. Excess body weight has been linked to both an increased risk of developing breast cancer and poor prognosis in women diagnosed with early stage disease. A recent meta-analysis of 82 studies demonstrated that risk of breast cancer mortality was increased by 35% in women who were obese at the time of breast cancer diagnosis compared to women who were of normal weight. The Breast cancer Weight Loss (BWEL) study will evaluate the effect of weight loss after breast cancer diagnosis on risk of cancer recurrence. Methods: BWEL is a Phase III randomized trial evaluating the impact of a telephone-based weight loss intervention vs control on invasive disease-free survival (iDFS) in 3136 overweight and obese women with Stage II-III breast cancer. Eligibility criteria include diagnosis of hormone receptor positive or triple negative breast cancer within the preceding 12 months, body mass index of ≥27kg/m2, and completion of surgery, chemotherapy, and radiation (if administered). Participants are randomized to a 2-year telephone- and mail-based weight loss intervention, adapted from the Diabetes Prevention Program, plus a health education program or to a health education alone control group. The study has 85% power, using a one-sided Type I error rate of 0.025, to detect a hazard ratio of 0.80 between groups. This equates to a 4.1% absolute reduction in iDFS events in the intervention group vs. controls. Secondary aims will evaluate the impact of the weight loss intervention upon overall survival, weight and body composition, and patient-reported outcomes. Fasting blood is collected serially over time, and tissue samples of malignant and benign breast tissue are collected at baseline to provide insight into the biologic mechanisms linking obesity and breast cancer. BWEL opened in September 2016. To date, 1015 patients have been randomized and more than 1100 sites in the US and Canada have activated the trial. Support: U10CA180821, U10CA180882, U10CA180820, U10CA180868, U10CA077202. Clinical trial information: NCT02750826.
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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 | 0.006 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.004 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.002 |
| 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".