Protocol Summary

Protocol No.: OCR16136

Sponsor Protocol No.: A011401; BWEL

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

Principal Investigator(s)
Daily Weinstein, Karen

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.

Health Education Program
Patients will receive a standardized intervention focusing on healthy living. This will include mailings at study entry and one year later describing healthy lifestyle behaviors. All participants will also receive a 2-year subscription to a health magazine. In addition, all study participants will be invited to join twice-yearly Webinars/teleconferences that focus on breast cancer and other health topics, such as treatment updates in breast cancer, management of menopausal side effects, general cancer screening, etc. Finally, the study will also provide birthday and holiday greeting cards and a twice-yearly study newsletter with study updates and other general breast cancer news.

Health Education Program + Weight Loss Intervention
Patients will receive a standardized intervention focusing on healthy living as described in the Arm 1 (Health Education Program). In addition, patients will utilize a standardized, 2-year, telephone-based weight loss intervention. The intervention will include individual weight loss, caloric restriction, and physical activity goals for each participant. It will be administered through semi-structured phone calls delivered by trained coaches at the BWEL call center and supplemented through print and on-line materials. The intervention will utilize a toolbox approach that will allow for tailoring for the individual participant.

Phase: Phase III

Age Group: Adult

Scope: National

Detailed Eligibility
1. Ages 18 years old and older
2. Documentation of Disease:
- Subjects must have histologically confirmed invasive breast cancer and registration must occur within 12 months after the first histologic diagnosis of invasive breast cancer.
- A core biopsy interpreted as invasive cancer meets this criterion; if no core biopsy is performed, the date of first histologic diagnosis will be the date of first surgical procedure that identifies invasive cancer (biopsy, lumpectomy or mastectomy).
- Neoadjuvant subjects should have no evidence of clinical T4 disease prior to chemotherapy and surgery; eligibility for neoadjuvant patients can be defined by either clinical stage prior to therapy or pathologic stage at surgery; if patient is eligible based on either, they are eligible for the study.
- Bilateral breast carcinoma is allowed provided diagnoses are synchronous - that is, within 3 months of one another - and at least one of the two breast carcinomas meet the eligibility criteria and neither Her-2 positive or inflammatory.
- No evidence of metastatic disease
- Her-2 negative, defined as:
- In-situ hybridization (ISH) ratio of - Immunohistochemistry (IHC) staining of 0-2+ (if performed)
- Deemed to not be a candidate for Her-2 directed therapy.
- Eligible tumor-node-metastasis (TNM) Stages include:
- Estrogen receptor (ER) and Progesterone receptor (PR) negative (defined as - ER and/or PR positive (defined as ≥ 1% staining for ER and/or PR on IHC): T0-3N1-3 or T3N0. Note: Patients with T1-2, N1mi disease are NOT eligible
- The eligibility of neo-adjuvant subjects can be assessed on the basis of clinical (c)TNM or pathologic (yp)TNM. The same eligible TNM combinations apply; patients may be eligible if they meet eligibility requirements at either time point, as long as they do not have T4 disease prior to therapy.
- No history of invasive 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

**Contact study team for complete eligibility details.

Applicable Disease Sites
Breast Cancer

Participating Institutions
UF Gainesville : Brandi Lattinville

Brandi Lattinville
Phone: +1 352-265-0680 ext. 87665


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