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Breast Cancer WEight Loss Study (BWEL Study)
Overall Recruitment Status: Active, currently enrolling
 
Official Title
Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Therapy of Overweight and Obese Women with Early Breast Cancer. Breast Cancer Weight Loss Study (BWEL Study)
 
Region Sponsors
Mid-Atlantic
Alliance for Clinical Trials in Oncology
 
Acronym KP IRB No.
BWEL Study MA-16-125
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Overweight / obese women with confirmed invasive breast cancer (tumors HER-2 negative).
 
Purpose
This randomized phase III trial studies whether weight loss in overweight 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 breast 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 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 care treatment.
 
Detailed Description
 
Gender Age Limit
Female
 
Inclusion Criteria
  • 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 < 2.0 (if performed). Immunochemistry (IHC) staining of 0-2+ (if performed). Deemed to not be a candidate for Her-2 directed therapy.
 
Exclusion Criteria
  • No evidence of metastatic disease.
  • 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 anytime is acceptable).
  • BMI must be < or = to 27. The most recent BMI obtained must be used for eligibility.
  • Patient may not be participating in another weight-loss, physical activity or dietary intervention clinical trial.

 
Keywords and/or Specific Medical Conditions
  • Breast Carcinoma
  • Weight Loss Intervention
  • Health Education
  • Oncology (Adult)
  • Overweight and Obese Women
  • Preventative Medicine
 
KP Clinical Facility
  • Burke Medical Center
  • Capitol Hill Medical Center
  • Gaithersburg Medical Center
  • Largo Medical Center
  • Tyson's Corner Medical Center
  • Woodlawn Medical Center
 
Clinical Area
  • Oncology (Adult)
  • Preventative Medicine


Principal Investigator:
Leon C Hwang, MD
Contact Information:
- Diane Fisher, RN
-301-386-6692
-Diane.Fisher@kp.org
-Largo Medical Center


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