Alliance A011401 Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer (CTMS# 16-0082)
To compare the effect of a supervised weight loss intervention plus health education materials versus health education materials alone upon invasive disease free survival (iDFS) in overweight (BMI 27-29.9 kg/m2) and obese (BMI 30kg/m2) women diagnosed with HER-2 negative, stage II and III breast cancer.
To determine the relationship between changes in weight and iDFS, and to explore interaction between the level of clinical benefit from weight loss and the intervention.
To evaluate the effect of a supervised weight loss intervention upon:
a) Overall survival
b) Distant disease free survival
d) Body composition (as measured by waist and hip circumference)
e) Insulin Resistance Syndrome associated conditions diabetes, hospitalization for
To determine the impact of a supervised weight loss intervention on IDFS within subgroups
of women with 1) hormone receptor positive breast cancer and 2) hormone receptor negative
To determine the impact of a supervised weight loss intervention on IDFS within subgroups of 1) premenopausal women and 2) post-menopausal women.