Table 1 BWEL (A011401) trial at a glance
Trial details | Description |
|---|---|
Rationale | • Observational evidence shows that women who are overweight or obese at the time of breast cancer diagnosis have a higher risk of breast cancer mortality compared to leaner women |
• The Women’s Interventional Nutrition Study (WINS) suggested that weight loss, achieved through dietary fat restriction, may be linked to a lower risk of breast cancer recurrence | |
• More than two-thirds of women diagnosed with breast cancer in the US are overweight or obese | |
Hypothesis | Weight loss, achieved through participation in a supervised weight loss intervention, will significantly improve invasive disease free survival in overweight and obese women with early-stage breast cancer |
Primary endpoint | Invasive disease free survival |
Secondary endpoints | • Overall survival |
• Distant disease-free survival | |
• Weight | |
• Body composition | |
Insulin resistance syndrome associated conditions – diabetes, hospitalization for CV disease | |
• Correlative science | |
Fasting metabolic and inflammatory biomarkers | |
Predictive tissue markers | |
• Health behaviors | |
Minutes of weekly exercise | |
Dietary intake | |
• Patient reported outcomes | |
Quality of life | |
Treatment-related side effects | |
Body image | |
Sleep | |
Integrated biomarkers | Fasting insulin, leptin and high sensitivity c-reactive protein |
Sample size | A target sample size of 3136 women will provide 85% power to detect a hazard ratio of 0.80 |
Assumptions: | |
• IDFS rate in control population of 77% | |
• One-sided type I error rate of 0.025 | |
• 4 years accrual and 4 years of additional follow up | |
Patient population | • Stage II–III breast cancer diagnosed within the last 12 months |
• Her-2 negative | |
• BMI ≥ 27 kg/m2 |
