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Breast Cancer WEight Loss Study
Overall Recruitment Status: Active, currently enrolling
 
Official Title
Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer (A011401)
 
Region Sponsors
Northwest
Alliance for Clinical Trials in Oncology
 
Acronym KP IRB No.
BWEL Study Pro00000645
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Breast Carcinoma
 
Purpose
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.
 
Detailed Description
This randomized controlled trial of weight loss interventions in overweight and obese women with early stage breast cancer consists of two arms, please see the arms section for more information. Patients will be randomized 1:1 within stratification factors: menopausal status (premenopausal vs. postmenopausal), hormone receptor status of the tumor (ER and/or PR positive vs. ER and PR negative), and race/ethnicity (African American vs. Hispanic vs. Other). The primary objective of this trial is to compare the effect of the telephone-based intervention versus a health educational control on invasive disease-free survival (IDFS). The total sample size is 3136 patients. Patient follow up for primary and secondary endpoints will continue to a maximum of 10 years, as per the standard protocol for cooperative group adjuvant trials. The primary and secondary objectives of the study: Primary objective: To compare the effect of a supervised weight loss intervention plus health education materials versus health education materials alone upon invasive disease free survival (IDFS) in overweight (BMI 27-29.9 kg/m2) and obese (BMI =30kg/m2) women diagnosed with HER-2 negative, stage II and III breast cancer. Secondary objectives: 1. To determine the relationship between changes in weight and IDFS, and to explore interaction between the level of clinical benefit from weight loss and the intervention. 2. To evaluate the effect of a supervised weight loss intervention upon: Overall survival; Distant disease free survival; Weight; Body composition (as measured by waist and hip circumference); Insulin Resistance Syndrome associated conditions - diabetes, hospitalization for CV disease; 3. To determine the impact of a supervised weight loss intervention on IDFS within subgroups of women with 1) hormone receptor positive breast cancer and 2) hormone receptor negative breast cancer. 4. To determine the impact of a supervised weight loss intervention on IDFS within subgroups of 1) premenopausal women and 2) post-menopausal women. Patients are to be followed every 6 months for the first 3 years after study enrollment and then annually until 10 years from registration. The intervention will last 2 years or until disease recurrence/progression, new invasive primary cancer as defined in the protocol or patient withdrawal.
 
Gender Age Limit
Female 18 years & older
 
Inclusion Criteria
  • 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 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
  • Surgical margins must be clear of invasive carcinoma. In situ lobular disease at the margin is acceptable.
  • All subjects 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.
  • Able to read and comprehend English.
  • *Please contact study team for more eligibility criteria
 
Exclusion Criteria
  • 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. Note: Patients with T1, N1mi disease are NOT eligible.
  • 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).
  • 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.
  • No 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). Patients cannot have metastatic breast or other cancer.
  • No diabetes mellitus currently treated with insulin or sulfonylureas.
  • No history of serious digestive and/or absorptive problems, including inflammatory bowel disease and chronic diarrhea that preclude adherence to the study diet.
  • No history of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility.
  • No prior bariatric surgery or planning to undergo this procedure within the next 2 years after study registration.
  • No comorbid conditions that would cause life expectancy of less than 5 years.
  • No history of psychiatric disorders that would preclude participation in the study intervention or prevent the patient from giving informed consent.

 
Keywords and/or Specific Medical Conditions
  • Body Weight
  • Neoplasms by Site
  • Body Weight Changes
  • Signs and Symptoms
  • Breast Diseases
  • Skin Diseases
  • Breast Neoplasms
  • Oncology (Adult)
  • Neoplasms
  • Weight Loss
 
KP Clinical Facility
  • Central Interstate Medical Office
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Abdul Hai Mansoor, MD
Contact Information:
- Rhonda Stephenson, RN
-503-331-6537
-rhonda.stephenson@kpchr.org
-Central Interstate Medical Office


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