Study ID: A011401
The breast cancer weight-loss study is for patients who have been diagnosed with early-stage breast cancer and are interested in losing weight. Researchers are trying to determine if losing weight and exercising more lowers the risk of cancer recurrence.
Participants will be randomly assigned to one of two groups:
- The weight-loss intervention group will take part in a telephone-based weight-loss program
- The health education group will receive mail or online information about breast cancer topics
Participation involves completing questionnaires, taking weight measurements and undergoing fasting blood draws at various points during the study.
- Histologically confirmed invasive breast cancer. Registration must have occurred within 12 months after first histologic diagnosis. Core biopsy. If no core biopsy performed, 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. See eligible cTNM classifications below.
- Bilateral BC allowed provided diagnoses are synchronous (within three months of one another and at least one of two breast carcinomas meet eligibility).
- Her-2 negative, defined as ISH ratio of < 2.0 (if performed); IHC staining of 0-2+ (if performed). Deemed to not be a candidate for Her-2 directed therapy.
- Eligible TNM Stages include ER/PR negative (defined as <1% staining for ER and PR by IHC): T2 or T3 N0, T0-3N1-3. ER and/or PR positive (defined as ≥ 1% staining for ER and/or PR on IHC): T0-3N1-3 or T3N0.
- No hx of invasive breast cancer in five years prior to study registration other than the current diagnosis (prior ductal breast carcinoma in situ [DCIS] at any time is acceptable).
- Must have been diagnosed with stage 2 or 3 breast cancer within the past 12 months
- Must have already completed surgery and chemotherapy, if applicable