This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.
This randomized controlled trial of weight loss interventions in overweight and obese women with early stage breast cancer consists of two arms, please see the arms section for more information. Patients will be randomized 1:1 within stratification factors: menopausal status (premenopausal vs. postmenopausal), hormone receptor status of the tumor (ER and/or PR positive vs. ER and PR negative), and race/ethnicity (African American vs. Hispanic vs. Other). The primary objective of this trial is to compare the effect of the telephone-based intervention versus a health educational control on invasive disease-free survival (IDFS). The total sample size is 3136 patients. Patient follow up for primary and secondary endpoints will continue to a maximum of 10 years, as per the standard protocol for cooperative group adjuvant trials.
The primary and secondary objectives of the study:
Primary objective 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.
Patients are to be followed every 6 months for the first 3 years after study enrollment and then annually until 10 years from registration. The intervention will last 2 years or until disease recurrence/progression, new invasive primary cancer as defined in the protocol or patient withdrawal.
|Treatment||Health Education Program, Weight loss intervention|
|Clinical Study Identifier||NCT02750826|
|Sponsor||Alliance for Clinical Trials in Oncology|
|Last Modified on||18 January 2021|
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