Last updated on May 2019

Breast Cancer WEight Loss Study (BWEL Study)


Brief description of study

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 Study 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:
  3. Overall survival
  4. Distant disease free survival
  5. Weight
  6. Body composition (as measured by waist and hip circumference)
  7. Insulin Resistance Syndrome associated conditions - diabetes, hospitalization for CV disease
  8. 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.
  9. 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.

Clinical Study Identifier: NCT02750826

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CHI Health Saint Francis

Grand Island, NE United States
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CHI Health Good Samaritan

Kearney, NE United States
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Midlands Community Hospital

Papillion, NE United States
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Desert West Surgery

Las Vegas, NV United States
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Hope Cancer Care of Nevada

Las Vegas, NV United States
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OptumCare Cancer Care at Oakey

Las Vegas, NV United States
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21st Century Oncology

Las Vegas, NV United States
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Ann M Wierman MD LTD

Las Vegas, NV United States
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University Cancer Center

Las Vegas, NV United States
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Portsmouth Regional Hospital

Portsmouth, NH United States
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Ocean Medical Center

Brick, NJ United States
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AtlantiCare Health Park-Cape May Court House

Cape May Court House, NJ United States
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AtlantiCare Surgery Center

Egg Harbor Township, NJ United States
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Hunterdon Medical Center

Flemington, NJ United States
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Bayshore Community Hospital

Holmdel, NJ United States
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Monmouth Medical Center

Long Branch, NJ United States
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Virtua Memorial

Mount Holly, NJ United States
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Jersey Shore Medical Center

Neptune, NJ United States
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Saint Peter's University Hospital

New Brunswick, NJ United States
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Penn Medicine Princeton Health

Plainsboro, NJ United States
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Chilton Memorial Hospital

Pompton, NJ United States
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Valley Hospital

Ridgewood, NJ United States
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Overlook Hospital

Summit, NJ United States
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Holy Name Hospital

Teaneck, NJ United States
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Community Medical Center

Toms River, NJ United States
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Virtua Voorhees

Voorhees, NJ United States
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Lovelace Medical Center-Downtown

Albuquerque, NM United States
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Lovelace Women's Hospital

Albuquerque, NM United States
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Jacobi Hospital

Bronx, NY United States
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Kings County Hospital

Brooklyn, NY United States
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Elmhurst Hospital Center

Elmhurst, NY United States
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Queens Hospital Center

Jamaica, NY United States
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NYU Winthrop Hospital

Mineola, NY United States
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Mount Sinai Union Square

New York, NY United States
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Mount Sinai West

New York, NY United States
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University of Rochester

Rochester, NY United States
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Wayne Memorial Hospital

Goldsboro, NC United States
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Cone Health Cancer Center

Greensboro, NC United States
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East Carolina University

Greenville, NC United States
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AdventHealth Hendersonville

Hendersonville, NC United States
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Onslow Memorial Hospital

Jacksonville, NC United States
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Rex Cancer Center

Raleigh, NC United States
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Duke Raleigh Hospital

Raleigh, NC United States
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Annie Penn Memorial Hospital

Reidsville, NC United States
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Rowan Regional Medical Center

Salisbury, NC United States
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Novant Health Forsyth Medical Center

Winston-Salem, NC United States
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Novant Health Oncology Specialists

Winston-Salem, NC United States
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Winston-Salem Health Care

Winston-Salem, NC United States
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Alliance Cancer Center

Alliance, OH United States
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Summa Barberton Hospital

Barberton, OH United States
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Indu and Raj Soin Medical Center

Beavercreek, OH United States
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Mercy Medical Center

Canton, OH United States
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Aultman Health Foundation

Canton, OH United States
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Miami Valley Hospital South

Centerville, OH United States
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The Christ Hospital

Cincinnati, OH United States
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Bethesda North Hospital

Cincinnati, OH United States
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Mount Carmel East Hospital

Columbus, OH United States
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Riverside Methodist Hospital

Columbus, OH United States
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Grant Medical Center

Columbus, OH United States
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Doctors Hospital

Columbus, OH United States
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Miami Valley Hospital

Dayton, OH United States
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Delaware Radiation Oncology

Delaware, OH United States
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Grady Memorial Hospital

Delaware, OH United States
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Armes Family Cancer Center

Findlay, OH United States
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Blanchard Valley Hospital

Findlay, OH United States
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Orion Cancer Care

Findlay, OH United States
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Dayton Physicians LLC-Atrium

Franklin, OH United States
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Dayton Physicians LLC-Wayne

Greenville, OH United States
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Wayne Hospital

Greenville, OH United States
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Greater Dayton Cancer Center

Kettering, OH United States
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First Dayton Cancer Care

Kettering, OH United States
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Kettering Medical Center

Kettering, OH United States
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Fairfield Medical Center

Lancaster, OH United States
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OhioHealth Mansfield Hospital

Mansfield, OH United States
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Marietta Memorial Hospital

Marietta, OH United States
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Knox Community Hospital

Mount Vernon, OH United States
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Licking Memorial Hospital

Newark, OH United States
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Newark Radiation Oncology

Newark, OH United States
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Saint Charles Hospital

Oregon, OH United States
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Southern Ohio Medical Center

Portsmouth, OH United States
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ProMedica Flower Hospital

Sylvania, OH United States
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University of Toledo

Toledo, OH United States
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Mercy Saint Anne Hospital

Toledo, OH United States
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Saint Ann's Hospital

Westerville, OH United States
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Wright-Patterson Medical Center

Wright-Patterson Air Force Base, OH United States
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Mercy Hospital Oklahoma City

Oklahoma City, OK United States
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Kaiser Permanente Northwest

Portland, OR United States
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Abington Memorial Hospital

Abington, PA United States
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Geisinger Medical Center

Danville, PA United States
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Einstein Medical Center Montgomery

East Norriton, PA United States
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Pocono Medical Center

East Stroudsburg, PA United States
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Easton Hospital

Easton, PA United States
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Ephrata Cancer Center

Ephrata, PA United States
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Ephrata Community Hospital

Ephrata, PA United States
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Adams Cancer Center

Gettysburg, PA United States
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Cherry Tree Cancer Center

Hanover, PA United States
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Lewistown Hospital

Lewistown, PA United States
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Riddle Memorial Hospital

Media, PA United States
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Paoli Memorial Hospital

Paoli, PA United States
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Aria Health-Torresdale Campus

Philadelphia, PA United States
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Einstein Center One

Philadelphia, PA United States
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Mercy Hospital of Philadelphia

Philadelphia, PA United States
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Nazareth Hospital

Philadelphia, PA United States
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Phoenixville Hospital

Phoenixville, PA United States
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UPMC-Magee Womens Hospital

Pittsburgh, PA United States
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UPMC-Presbyterian Hospital

Pittsburgh, PA United States
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UPMC-Saint Margaret

Pittsburgh, PA United States
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UPMC-Shadyside Hospital

Pittsburgh, PA United States
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UPMC-Passavant Hospital

Pittsburgh, PA United States
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Pottstown Hospital

Pottstown, PA United States
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Community Medical Center

Scranton, PA United States
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Geisinger Medical Group

State College, PA United States
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Chester County Hospital

West Chester, PA United States
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