A Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer (B-Well Trial) (Alliance A011401)

Study Details

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.

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ClinicalTrials.gov NCT number
NCT02750826

Principal Investigators

  • Steve Lo, MD
Sponsor(s)
Alliance for Clinical Trials in Oncology
Contact
Mary Miller, LPN at 203-358-8879
or officeofresearch@stamhealth.org

Location

  • Bennett Cancer Center
    One Hospital Plaza
    Stamford, CT 06902
    Main: 203-276-2695