Skip to content

BWEL (Alliance A011401) — Telephone-based weight loss intervention, stage II/III HER2-negative early breast cancer (BMI ≥27), adjuvant lifestyle

Abstract: 12010 · Session: 2026 ASCO Annual Meeting (health outcomes substudy presentation) · Presenter: Jennifer A. Ligibel, MD, FASCO (Dana-Farber Cancer Institute, Boston)

At a glance

  • Sponsor: National Cancer Institute / NIH (Alliance for Clinical Trials in Oncology). Additional support: Breast Cancer Research Stamp Fund, Susan G. Komen, Breast Cancer Research Foundation, American Cancer Society
  • PI / presenter: Jennifer A. Ligibel, MD, FASCO — Dana-Farber Cancer Institute
  • NCT ID: NCT02750826
  • Phase: 3
  • Design: Randomized 1:1, phase III. Health education alone vs health education + telephone-based weight loss intervention (up to 42 coach-delivered sessions over 2 years; individualized 500–1,000 kcal/day deficit targeting ~10% weight loss; ramp to 225 min/week moderate activity). The ASCO 2026 readout is the Health Outcomes (HO-1) patient-reported-outcome substudy.
  • N: 3,180 randomized in the main trial (enrolled 2016–2021 across ~635 practices in US/Canada); HO-1 substudy 542 (intervention n=272, control n=270)
  • Primary endpoint(s): Main trial — invasive disease-free survival (iDFS, follow-up ongoing). HO-1 substudy — physical function at 6 months
  • Comparator: Health education alone
  • Indication: Stage II–III HR+/HER2-negative or triple-negative early breast cancer with BMI ≥27 kg/m², after surgery and chemo/radiation as indicated
  • Line: Adjuvant (lifestyle intervention)

Headline result

In the BWEL HO-1 substudy (n=542), the telephone-based weight loss intervention produced clinically meaningful, durable weight loss and improved patient-reported physical function and quality of life. Participants in the intervention arm lost ~5.7% of baseline body weight at 12 months versus controls. At the 6-month primary timepoint, the intervention significantly improved physical function (+1.9 points, P<.001), global physical health (+2.0, P<.001), global mental health (+1.3, P=.03), social roles/activities (+2.3, P<.001), and reduced fatigue (−1.7, P=.01) versus health education alone. Benefits were generally maintained at 2 years after enrollment. The primary invasive disease-free survival endpoint of the parent trial has not yet read out and follow-up is ongoing.

Mechanism / class

Behavioral lifestyle intervention (not a drug). Mechanistic rationale: obesity is associated with worse breast cancer outcomes; caloric restriction plus increased physical activity reduce adiposity, insulin/IGF signaling, and inflammation. Delivered remotely by trained weight-loss coaches to enable broad, scalable access.

Discussant takeaway

Not reported in available sources.

Practice-changing?

Pending. The HO-1 substudy establishes that a scalable telephone-based program delivers durable weight loss and meaningful quality-of-life/physical-function gains, strengthening the case for offering structured lifestyle support in survivorship care. Whether weight loss improves cancer outcomes awaits the parent trial's invasive disease-free survival readout; the iDFS result will determine any change to adjuvant treatment standards.

Sources

  • ASCO Meeting Library / Program (Abstract 12010): https://meetings.asco.org/abstracts-presentations/223191
  • The ASCO Post: https://ascopost.com/news/may-2026/early-stage-breast-cancer-losing-weight-gaining-quality-of-life/
  • CancerNetwork: https://www.cancernetwork.com/view/telephone-based-weight-loss-program-improves-physical-function-qol-in-breast-cancer
  • Medscape: https://www.medscape.com/viewarticle/telephone-weight-loss-coaching-pays-breast-cancer-2026a1000gyt