Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women With Early Breast Cancer
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
Conditions: breast cancer
Age: Between 18 - 100 Years
Subjects must have histologically confirmed invasive breast cancer and registration must occur within 12 months after the first histologic diagnosis of invasive breast cancer
Eligible TNM Stages include:
Estrogen receptor (ER) and Progesterone receptor (PR) negative (defined as e breast cancer in 5 years prior to study registration other than the current diagnosis (prior ductal breast carcinoma in situ [DCIS] at any time is acceptable)
Patients must have had a bilateral mammogram within 12 months prior to registration, unless the initial surgery was a total mastectomy, in which case only a mammogram of the remaining breast is required. (Subjects with bilateral total mastectomies do not require imaging)
Investigations, including chest X-ray or computed tomography (CT) chest, bone scan (with radiographs of suspicious areas) and abdominal ultrasound or liver scan or CT abdomen have been performed between the first histologic diagnosis and the time of registration as detailed below
Chest X-Ray, 2 view (or Chest CT, or positron emission tomography [PET]/CT) is mandatory
Bone scans (with x-rays of abnormal areas) are required only if alanine aminotransferase (ALT), aspartate aminotransferase (AST) or Alkaline Phosphatase is elevated or if there are signs or symptoms of metastatic disease
Abdominal imaging is required only if ALT, AST or Alkaline Phosphatase is elevated or if there are signs or symptoms of metastatic disease
All adjuvant or neoadjuvant chemotherapy (at the discretion of the treating physician) and surgery completed at least 21 days prior to registration. Concomitant radiation, biologic therapy, hormonal therapy, and bisphosphonates are acceptable
Surgical margins must be clear of invasive carcinoma. If there is microscopic residual ductal in situ disease present at lumpectomy or total mastectomy margins, further excision is highly recommended. If further excision is not undertaken, the subject may still be entered on study, provided that in addition to breast or chest wall irradiation, a boost to the tumor bed is delivered. In situ lobular disease at the margin is acceptable.
All subjects (both adjuvant and neo-adjuvant) must have sentinel lymph node biopsy and/or axillary lymph node dissection
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
BMI ?27 kg/m2 documented within 56 days prior to study registration
Self-reported ability to walk at least 2 blocks (at any pace)
Not participating in another weight loss, physical activity or dietary intervention clinical trial. Co-enrollment in trials involving pharmacologic therapy is allowed. Participants in both arms are also allowed to pursue weight loss and physical activity programs on their own, as long as these programs are not provided as part of a clinical trial
Able to read and comprehend English
History of other malignancy within the past 4 years, except for malignancies with a >95% likelihood of cure (e.g. non-melanoma skin cancer, papillary thyroid cancer, in situ cervical cancer)
Diabetes mellitus currently treated with insulin or sulfonylureas
History of serious digestive and/or absorptive problems, including inflammatory bowel disease and chronic diarrhea that preclude adherence to the study diet
History of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity
Prior bariatric surgery or planning to undergo this procedure within the next 2 years after study registration
Comorbid conditions that would cause life expectancy of less than 5 years.
History of psychiatric disorders that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder) or prevent the patient from giving informed consent
Contact the research team to learn more about this study.
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