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Phase 3 BWEL Substudy: Weight Loss Intervention Improves QOL in Stage II-III Breast Cancer

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Key Highlights

  • The BWEL substudy evaluated patient-reported quality of life and symptoms among the first 540 trial participants.
  • Participants had stage II-III breast cancer and BMI of at least 27 kg/m².
  • At 6 months, the weight loss intervention improved physical function, global physical health, global mental health, social roles and activities, and fatigue compared with health education alone.
  • Improvements were generally maintained at 24 months.

A lifestyle-based weight loss intervention improved patient-reported quality of life and symptoms among women with stage II-III breast cancer and BMI of at least 27 kg/m² in a substudy of the phase 3 Breast Cancer Weight Loss (BWEL) trial, according study findings that will be presented at the 2026 American Society of Clinical Oncology Annual Meeting in Chicago, IL..

BWEL randomized patients with stage II-III breast cancer and BMI of at least 27 kg/m² 1:1 to a 24-month lifestyle-based weight loss intervention plus health education or health education alone. This substudy included the first 540 BWEL patients, who were randomized between September 2016 and July 2017. PROMIS 29 Profile 2.0 and Global Health scores were collected at enrollment, 6 months, and 24 months.

Researchers compared mean physical function, the predefined substudy primary outcome, as well as global physical and mental health, fatigue, and other scores at 6 and 24 months using analysis of covariance adjusted for baseline scores.

Study Findings

At baseline, median BMI was 32.9 kg/m², with a range of 26.5 to 69.1 kg/m². Median age was 53 years, with a range of 25 to 78 years. Most patients were non-Hispanic White (83.9%); 10.7% were Black, and 5.9% were Hispanic.

At 6 months, the weight loss intervention arm had significantly better physical function than the health education arm, with an analysis of covariance–based mean difference of 1.9 (95% CI, 0.8-3.0; P < .001). The intervention arm also had significantly better global physical health, with a mean difference of 2.0 (95% CI, 0.9-3.0; P < .001); global mental health, with a mean difference of 1.3 (95% CI, 0.2-2.4; P = .03); social roles and activities, with a mean difference of 2.3 (95% CI, 1.1-3.6; P < .001); and fatigue, with a mean difference of -1.7 (95% CI, -3.1 to -0.4; P = .01). Improvements were generally maintained at 24 months. Similar findings were reported in analyses using longitudinal mixed modeling.

Clinical Implications

According to the study authors, the BWEL weight loss intervention demonstrated quality-of-life benefits for patients with breast cancer, resulting in significantly better physical function, global physical and mental health, and symptoms. The authors stated that future analyses will evaluate which populations experienced the most benefit, as well as relationships among quality of life, symptoms, and weight loss.

Expert Commentary

“The BWEL weight loss intervention demonstrated quality-of-life benefits for patients with breast cancer, resulting in significantly better physical function, global physical and mental health, and symptoms,” the researchers concluded.


Reference
Ligibel JA, Hershman DL, Dueck AC, McCall LM, Ginos BF, Goodwin PJ, et al. Effect of a weight loss intervention (WLI) on quality of life (QOL) and symptoms in women with breast cancer: results from the Breast Cancer Weight Loss (BWEL) trial. Presented at: 2026 American Society of Clinical Oncology Annual Meeting; abstract 12010.