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Protocol No. A011401

Principal Investigator Tevaarwerk, Amye

Phase III

Age Group Adult

Scope National

Sponsor Type National

Title Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer

Objective This study is being done to see if losing weight may help prevent breast cancer from coming back (recurring). 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. At this time we do not know whether or not losing weight will reduce the risk of breast cancer returning. This study seeks to determine whether or not the higher risk for breast cancer recurrence in women who are overweight or obese when they are diagnosed with breast cancer could be reduced or eliminated if weight is lost. It is important to note that we do not know how much weight would need to be lost to lower the risk of breast cancer recurrence, or whether this strategy would work for all women. This study will help to show us whether weight loss programs should be a part of breast cancer treatment.

Treatment A computer will by chance assign you to one of study groups described above. This is called randomization. This is done by chance because no one knows if one study group is better or worse than the others.Group 1 will get a Health Education program that is designed to give women more information about their breast cancer, as well as general information about their general health.Group 2 will get the Health Education program described above and will also get a 2-year weight loss program. This program will be designed to help women lose about 10% of their starting weight by decreasing the calories they eat and by increasing their exercise.

Description Group 1 will receive a subscription to a Health magazine and they will receive mailings twice per year with brochures that provide information about breast cancer and health issues. Women will also receive a study newsletter twice per year, and will be able to take part in webinars or teleconferences twice per year that provide information about new updates in breast cancer.

Group 2 will have exercise goals that increase slowly over the study, with an overall goal of getting all women exercising at least 150 minutes per week over time. The weight loss program will be provided through a series of 42 telephone calls over 2 years. Each call will take 20-30 minutes. Each woman will be assigned a health coach who will work with her over the 2-year program. Women will need to track the food they eat and the exercise they do each day, especially in the early stages of the program. This will take approximately 15-20 minutes per day. Coaches will track progress using computer programs. Women in the weight loss group will also receive a weight loss workbook, an activity sensor, a cookbook, a journal and access to a study website to track diet, weight and exercise, a scale, food scale and measuring cups, optional text messages to help women meet exercise and diet goals, and optional pre-packaged shakes, bars or portion-controlled entrees to replace meals.

Key Eligibility
  • Subjects must have histologically confirmed invasive breast cancer and registration must occur within 12 months after the first histologic diagnosis of invasive breast cancer
  • Her-2 negative
  • ER and PR negative
  • ER and/or PR positive
  • No history of invasive breast cancer in 5 years prior to study registration other than the current diagnosis (prior DCIS at any time is acceptable)
  • Patients cannot have metastatic breast or other cancer
  • All subjects must have sentinel lymph node biopsyand/or axillary lymph node dissection
  • All adjuvant or neoadjuvant chemotherapy, radiation, and surgery completed at least 21 days prior to registration
  • Patients may have reconstructive surgery during protocol participation
  • Patients with hormone receptor positive breast cancer must plan to receive at least 5 years of adjuvant hormonal therapy
  • All women who undergo breast conserving therapy must receive concomitant radiotherapy
  • Participants must be women
  • BMI ≥27 documented within 56 days prior to study registration
  • Self-reported ability to walk at least 2 blocks (at any pace)
  • No prior bariatric surgery or planning to undergo this procedure within the next 2 years after study registration
  • No history of serious digestive and/or absorptive problems, including inflammatory bowel disease and chronic diarrhea that preclude adherence to the study diet
  • Not participating in another weight loss, physical activity or dietary intervention clinical trial

Applicable Disease Sites Breast

Therapies Involved Other

Status Open

Participating Institutions Bellin Memorial Hospital/Cancer Team at Bellin Health; Dean Health System, Hematology and Oncology Clinic ; Johnson Creek, UW Cancer Center; Mercy Health Systems, Janesville ; Swedish American Hospital, Rockford ; UW Hospital and Clinics; UWCCC 1 South Park