A011401 (BWEL)Weight Loss Interventions in Treating Overweight and Obese Women with a Higher Risk for Breast Cancer Recurrence - Mercy Medical Center

A011401 (BWEL)Weight Loss Interventions in Treating Overweight and Obese Women with a Higher Risk for Breast Cancer Recurrence

Posted on: January 28, 2020

This randomized phase III trial studies weight loss interventions in treating overweight and obese women with a higher risk for breast cancer that comes back (recurrence). Many studies have shown that women who are overweight or obese when diagnosed with breast cancer appear to have a higher risk of cancer recurrence. 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 program.

Eligibility includes being at least 18 years old and:

BMI > or = 27

•Subjects must have histologically confirmed invasive breast cancer and registration must occur within 14 months after the first histologic diagnosis of invasive breast cancer

•Eligible tumor-node-metastasis (TNM) stages include: * Estrogen receptor (ER) and progesterone receptor (PR) negative (defined as <1% staining for ER and PR by IHC): T2 or T3 N0, T0-3N1-3. Stage II or III disease

•Her-2 negative

•All adjuvant or neoadjuvant chemotherapy, radiation, and surgery completed at least 21 days prior to registration. Patients may have breast reconstruction during protocol participation, but definitive breast cancer surgery must be completed at least 21 days prior to registration ** Concomitant biologic therapy, hormonal therapy, and bisphosphonates are acceptable

•All women who undergo breast conserving therapy must receive concomitant radiotherapy; radiation after mastectomy is to be administered according to pre-specified institutional guidelines; radiation must be completed at least 21 days prior to registration

•Patients with hormone receptor positive breast cancer as defined above must plan to receive at least 5 years of adjuvant hormonal therapy in the form of tamoxifen or an aromatase inhibitor, alone or in combination with ovarian suppression

•No diabetes mellitus currently treated with insulin or sulfonylureas

 

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