OnCo
trialsTrialMixed

BWEL (Breast Cancer Weight Loss, Alliance A011401)

BWEL is a trial of more than 3,000 women testing whether losing weight after breast cancer treatment reduces recurrence. The programme achieved weight loss; the effect on recurrence was not clearly shown at the first analysis.

BWEL randomised 3,181 women within 12 months of diagnosis to a two-year telephone-delivered lifestyle programme (calorie restriction, 150-225 minutes of moderate activity per week, 42 coaching calls) plus health education, or health education alone; the primary endpoint was invasive disease-free survival. The intervention produced significantly greater weight loss at 12 and 24 months than the control arm. Primary efficacy results were presented in late 2025 and reported as not demonstrating a statistically significant improvement in invasive disease-free survival at the planned analysis; full peer-reviewed publication and longer follow-up are awaited, and the effect sizes below should be checked against the publication when available. Interpretation is contested: the weight loss achieved was modest (a few percent of body weight), follow-up is relatively short for HR-positive disease, and secondary cardiometabolic and quality-of-life benefits were seen. BWEL is the largest lifestyle-intervention trial ever run in cancer survivors and its design (telephone coaching, scalable) remains the template.

Setting
Stage II-III HR-positive or HER2-positive breast cancer, BMI at least 27: 2-year telephone-based weight-loss intervention plus health education vs health education alone
Phase
Phase 3
Sponsor
Alliance for Clinical Trials in Oncology / NCI
Registry
Headline result
Weight loss achieved; primary iDFS endpoint not met at first analysis (presented 2025; publication pending, verify).
Reported
2025
Enrolled
3181
Replication
Not applicable yet. Earlier diet-only trials in breast cancer survivors (WHEL, WINS) were null or marginal on recurrence.

Notes

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  • Record written before the peer-reviewed primary publication; numerical results deliberately omitted.

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