AzTrials
AzTrials

Breast Ductal Carcinoma In SituPhase 3NCT02750826

Breast Cancer WEight Loss Study (BWEL Study)

A Phase 3 study testing Health Education Program and Weight Loss Intervention in people with Breast Ductal Carcinoma In Situ and Invasive Breast Carcinoma, run by Alliance for Clinical Trials in Oncology at 1,498 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This randomized phase III trial compares 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Health Education Program and Weight Loss Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,177 participants
Where
1,498 sitesin 4 countries
Study dates
16 Sep 2016to 30 May 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult
  1. Documentation of Disease: 1.1 Subjects must have histologically confirmed invasive breast cancer and registration must occur within 16 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 either: 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 is: Her-2 positive or inflammatory; OR ** The contralateral breast cancer was at least 5 years prior to the current diagnosis * No evidence of metastatic or locally recurrent disease Her-2 negative, defined as:
  • In-situ hybridization (ISH) ratio of < 2.0 (if performed)
  • Immunohistochemistry (IHC) staining of 0-2+ (if performed)
  • Deemed to not be a candidate for Her-2 directed therapy. 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. Note: Patients with T1, N1mi disease are NOT eligible.
  • ER and/or PR positive (defined as ≥ 1% staining for ER and/or PR on IHC): T0-3N1-3 or T3N0. Note: Patients with T0N0, T1N0, T2N0 or T1N1mi and T2N1mi disease are NOT eligible.
  • The eligibility of neo-adjuvant subjects can be assessed on the basis of clinical (c)TNM or pathologic (yp)TNM. The same eligible TNM combinations apply; patients may be eligible if they meet eligibility requirements at either time point, as long as they do not have T4 disease prior to therapy. 1.4 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 does not make a patient ineligible). 1.5 Patients must have had a bilateral mammogram within 16 months prior to registration, unless the initial surgery was a total mastectomy, in which case only a mammogram of the remaining breast is required. (Subjects with bilateral total mastectomies do not require imaging). 1.6 Investigations, including chest X-ray or computed tomography (CT) chest, bone scan (with radiographs of suspicious areas) and abdominal ultrasound or liver scan or CT abdomen have been performed between the first histologic diagnosis and the time of registration as detailed below.
  • Chest X-Ray, 2 view (or Chest CT, or positron emission tomography [PET]/CT) is required only if clinically indicated or recommended by National Comprehensive Cancer Network (NCCN) guidelines
  • Bone scans (with x-rays of abnormal areas) are required only if indicated or recommended by NCCN guidelines.
  • Abdominal imaging is required only if indicated or recommended by NCCN guidelines.
  1. Prior Treatment 2.1 All adjuvant or neoadjuvant chemotherapy, radiation, and surgery completed at least 21 days prior to registration. 2.2 All triple negative patients must receive chemotherapy of the treating physician's choice. 2.3 ER/PR+ patients must receive chemotherapy (of the treating physician's choice) unless Oncotype Dx or another genomic predictor score indicates that they are at low or intermediate risk of disease recurrence with endocrine therapy alone. 2.4 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. 2.5 Surgical margins must be clear of invasive carcinoma. If there is microscopic residual ductal in situ disease present at lumpectomy or total mastectomy margins, further excision is highly recommended. If further excision is not undertaken, the subject may still be entered on study, provided that in addition to breast or chest wall irradiation, a boost to the tumor bed is delivered. In situ lobular disease at the margin is acceptable. 2.6 All subjects (both adjuvant and neoadjuvant) must have sentinel lymph node biopsy and/or axillary lymph node dissection as per pre-specified institutional guidelines.
  • All women who undergo breast conserving therapy must receive concomitant radiotherapy. Radiation after mastectomy is to be administered according to prespecified 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. (NOTE: for patients with ER and PR staining in less than 5% of cells, hormonal therapy for at least 5 years is strongly recommended but not required). Hormonal therapy can be initiated prior to or during protocol therapy.
  1. Participants must be women
  2. Age ≥ 18 years
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
  4. Comorbid Conditions

6.1 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.

6.2 No diabetes mellitus currently treated with insulin or sulfonylureas.

6.3 No history of serious digestive and/or absorptive problems, including inflammatory bowel disease and chronic diarrhea that preclude adherence to the study diet.

6.4 No history of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility.

6.5 No prior bariatric surgery or planning to undergo this procedure within the next 2 years after study registration. • No use of weight loss medications (with the exception of metformin) at the time of study enrollment or plans to take these agents within the next 2 years after study enrollment

6.6 No comorbid conditions that would cause life expectancy of less than 5 years.

6.7 No history of psychiatric disorders that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder) or prevent the patient from giving informed consent.

  • No chronic (>= 1 month) use of oral steroids at the time of study enrollment; inhaled or topical steroids are acceptable; patients previously taking oral steroids are required to undergo a 30-day washout prior to registration

7.1 BMI ≥27 kg/m2 documented within 56 days prior to study registration. The most recent BMI obtained must be used for eligibility. If most recent BMI is <27 then the patient is not eligible to enroll.

7.2 Self-reported ability to walk at least 2 blocks (at any pace).

7.3 Not participating in another weight loss, physical activity or dietary intervention clinical trial. Co-enrollment in some trials involving pharmacologic therapy is allowed. Participants in both arms are also allowed to pursue weight loss and physical activity programs on their own, as long as these programs are not provided as part of a clinical trial.

7.4 Able to read and comprehend English or Spanish. Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read lifestyle intervention materials and communicate with a coach through 42 phone calls over 2 years; the trial is unable to accommodate the needs of deaf participants as the study relies on spoken language to provide coaching

Trial locations and contacts

1,498 sites in 4 countries.

334 sites in 4 countries

United States300 sites

  • Hawaii Cancer Care - Savio

    ‘Aiea, Hawaii, 96701

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • Queen's Cancer Center - Pearlridge

    ‘Aiea, Hawaii, 96701

  • The Cancer Center of Hawaii-Pali Momi

    ‘Aiea, Hawaii, 96701

  • Avera Cancer Institute-Aberdeen

    Aberdeen, South Dakota, 57401

  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

  • Hendrick Medical Center

    Abilene, Texas, 79601

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Hickman Cancer Center

    Adrian, Michigan, 49221

  • Riverwood Healthcare Center

    Aitkin, Minnesota, 56431

  • Summa Health System - Akron Campus

    Akron, Ohio, 44304

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307

  • Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

  • Saint Peter's Health Partners

    Albany, New York, 12208

  • Mayo Clinic Health System in Albert Lea

    Albert Lea, Minnesota, 56007

  • Lovelace Medical Center-Downtown

    Albuquerque, New Mexico, 87102

  • Lovelace Medical Center-Saint Joseph Square

    Albuquerque, New Mexico, 87102

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • Lovelace Women's Hospital

    Albuquerque, New Mexico, 87109

  • Presbyterian Kaseman Hospital

    Albuquerque, New Mexico, 87110

  • Christus Saint Frances Cabrini Hospital

    Alexandria, Louisiana, 71301

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • Aultman Alliance Community Hospital

    Alliance, Ohio, 44601

  • The Don and Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

  • American Fork Hospital / Huntsman Intermountain Cancer Center

    American Fork, Utah, 84003

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic PC - Ames

    Ames, Iowa, 50010

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • Cancer Care Center at Island Hospital

    Anacortes, Washington, 98221

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92806

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, 98508

  • Anchorage Radiation Therapy Center

    Anchorage, Alaska, 99504

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • Saint Vincent Anderson Regional Hospital/Cancer Center

    Anderson, Indiana, 46016

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • UTMB Health Angleton Danbury Campus

    Angleton, Texas, 77515

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Langlade Hospital and Cancer Center

    Antigo, Wisconsin, 54409

  • Kaiser Permanente-Deer Valley Medical Center

    Antioch, California, 94531

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

  • Ascension Saint Elizabeth Hospital

    Appleton, Wisconsin, 54915

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005

  • Mission Hope Medical Oncology - Arroyo Grande

    Arroyo Grande, California, 93420

  • PCR Oncology

    Arroyo Grande, California, 93420

  • Randolph Hospital

    Asheboro, North Carolina, 27203

  • AdventHealth Infusion Center Asheville

    Asheville, North Carolina, 28803

  • Duluth Clinic Ashland

    Ashland, Wisconsin, 54806

  • Northwest Wisconsin Cancer Center

    Ashland, Wisconsin, 54806

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Kaiser Permanente-Glenlake Medical Center

    Atlanta, Georgia, 30328

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

  • Northside Hospital

    Atlanta, Georgia, 30342

  • John Fitzgerald Kennedy Medical Center

    Atlantis, Florida, 33462

  • Sutter Auburn Faith Hospital

    Auburn, California, 95602

  • Sutter Cancer Centers Radiation Oncology Services-Auburn

    Auburn, California, 95603

  • Hematology Oncology Associates of Central New York-Auburn

    Auburn, New York, 13021

  • MultiCare Auburn Medical Center

    Auburn, Washington, 98001

  • Augusta Oncology Associates PC-D'Antignac

    Augusta, Georgia, 30901

  • Augusta Oncology Associates PC-Wheeler

    Augusta, Georgia, 30909

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • Harold Alfond Center for Cancer Care

    Augusta, Maine, 04330

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • Dell Seton Medical Center at The University of Texas

    Austin, Texas, 78701

  • Mount Sinai Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180

  • Virginia Mason Bainbridge Island Medical Center

    Bainbridge Island, Washington, 98110

  • Saint Alphonsus Medical Center-Baker City

    Baker City, Oregon, 97814

  • AIS Cancer Center at San Joaquin Community Hospital

    Bakersfield, California, 93301

  • Kaiser Permanente-Baldwin Park

    Baldwin Park, California, 91706

  • Saint Louis Cancer and Breast Institute-Ballwin

    Ballwin, Missouri, 63011

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229

  • MedStar Franklin Square Medical Center/Weinberg Cancer Institute

    Baltimore, Maryland, 21237

  • MedStar Good Samaritan Hospital

    Baltimore, Maryland, 21239

  • Kaiser Permanente-Woodlawn Medical Center

    Baltimore, Maryland, 21244

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Summa Health System - Barberton Campus

    Barberton, Ohio, 44203

  • Flaget Memorial Hospital

    Bardstown, Kentucky, 40004

  • LSU Health Baton Rouge-North Clinic

    Baton Rouge, Louisiana, 70805

  • Louisiana Hematology Oncology Associates LLC

    Baton Rouge, Louisiana, 70809

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Ochsner Health Center-Summa

    Baton Rouge, Louisiana, 70809

  • Our Lady of the Lake Physicians Group - Medical Oncology

    Baton Rouge, Louisiana, 70809

  • Medical Center of Baton Rouge

    Baton Rouge, Louisiana, 70816

  • Woman's Hospital

    Baton Rouge, Louisiana, 70817

  • Ochsner High Grove

    Baton Rouge, Louisiana, 70836

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • McLaren Cancer Institute-Bay City

    Bay City, Michigan, 48706

  • Beaufort Memorial Hospital

    Beaufort, South Carolina, 29902

  • Baptist Hospitals of Southeast Texas Cancer Center

    Beaumont, Texas, 77701

  • UPMC-Heritage Valley Health System Beaver

    Beaver, Pennsylvania, 15009

  • Indu and Raj Soin Medical Center

    Beavercreek, Ohio, 45431

  • UM Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014

  • Waldo County General Hospital

    Belfast, Maine, 04915

  • Nebraska Medicine-Bellevue

    Bellevue, Nebraska, 68123

  • Overlake Medical Center

    Bellevue, Washington, 98004

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Gaston Hematology and Oncology Associates-Belmont

    Belmont, North Carolina, 28012

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Saint Charles Health System

    Bend, Oregon, 97701

  • Southwestern Vermont Medical Center

    Bennington, Vermont, 05201

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • Mac Neal Hospital

    Berwyn, Illinois, 60402

  • Suburban Hospital

    Bethesda, Maryland, 20814

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889-5600

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • University of Iowa Healthcare Cancer Services Quad Cities

    Bettendorf, Iowa, 52722

  • Beverly Hospital

    Beverly, Massachusetts, 01915

  • MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford

    Biddeford, Maine, 04005

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Saint Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • McLaren Cancer Institute-Bloomfield

    Bloomfield, Michigan, 48302

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • IU Health Bloomington

    Bloomington, Indiana, 47403

  • Saint Joseph's/Candler - Bluffton Campus

    Bluffton, South Carolina, 29910

  • Saint Elizabeth Boardman Hospital

    Boardman, Ohio, 44512

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

  • Parkland Health Center-Bonne Terre

    Bonne Terre, Missouri, 63628

  • McFarland Clinic PC-Boone

    Boone, Iowa, 50036

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

  • Cox Cancer Center Branson

    Branson, Missouri, 65616

  • Harrison HealthPartners Hematology and Oncology-Bremerton

    Bremerton, Washington, 98310

  • Harrison Medical Center

    Bremerton, Washington, 98310

  • Lafayette Family Cancer Center-EMMC

    Brewer, Maine, 04412

  • Ocean Medical Center

    Brick, New Jersey, 08724

  • United Hospital Center

    Bridgeport, West Virginia, 26330

  • Steward Saint Elizabeth's Medical Center

    Brighton, Massachusetts, 02135

  • IHA Hematology Oncology Consultants-Brighton

    Brighton, Michigan, 48114

  • Saint Joseph Mercy Brighton

    Brighton, Michigan, 48114

  • Wellmont Bristol Regional Medical Center

    Bristol, Tennessee, 37620

  • Wellmont Medical Associates Oncology and Hematology-Bristol

    Bristol, Tennessee, 37620

  • Wellmont Medical Associates-Bristol

    Bristol, Virginia, 24201

  • Ascension Southeast Wisconsin Hospital - Elmbrook Campus

    Brookfield, Wisconsin, 53045

  • Kings County Hospital

    Brooklyn, New York, 11203

  • New York-Presbyterian/Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

  • Crozer-Keystone Regional Cancer Center at Broomall

    Broomall, Pennsylvania, 19008

  • Henry Ford Cancer Institute-Downriver

    Brownstown, Michigan, 48183

  • Saint Joseph Regional Cancer Center

    Bryan, Texas, 77802

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Highline Medical Center-Main Campus

    Burien, Washington, 98166

  • Kaiser Permanente-Burke Medical Center

    Burke, Virginia, 22015

  • Mills-Peninsula Medical Center

    Burlingame, California, 94010

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • Cone Health Cancer Center at Alamance Regional

    Burlington, North Carolina, 27215

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Cambridge Medical Center

    Cambridge, Minnesota, 55008

  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park

    Cameron Park, California, 95682

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • IHA Hematology Oncology Consultants-Canton

    Canton, Michigan, 48188

  • Saint Joseph Mercy Canton

    Canton, Michigan, 48188

  • Hematology and Oncology Associates Inc

    Canton, Ohio, 44708

  • Mercy Medical Center

    Canton, Ohio, 44708

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • AtlantiCare Health Park-Cape May Court House

    Cape May Court House, New Jersey, 08210

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • IU Health North Hospital

    Carmel, Indiana, 46032

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Caro Cancer Center

    Caro, Michigan, 48723

  • Carson Tahoe Regional Medical Center

    Carson City, Nevada, 89703

  • SIH Cancer Institute

    Carterville, Illinois, 62918

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Rex Hematology Oncology Associates-Cary

    Cary, North Carolina, 27518

  • Waverly Hematology Oncology

    Cary, North Carolina, 27518

  • Eden Hospital Medical Center

    Castro Valley, California, 94546

  • Sandra L Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Physicians' Clinic of Iowa PC

    Cedar Rapids, Iowa, 52402

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Rocky Mountain Cancer Centers - Centennial

    Centennial, Colorado, 80112

  • Dayton Physicians LLC-Miami Valley South

    Centerville, Ohio, 45459

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

  • Chambersburg Hospital

    Chambersburg, Pennsylvania, 17201

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Ralph H Johnson VA Medical Center

    Charleston, South Carolina, 29401

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • Oncology Specialists of Charlotte

    Charlotte, North Carolina, 28207

  • Southern Oncology Specialists-Charlotte

    Charlotte, North Carolina, 28262

  • Memorial Hospital

    Chattanooga, Tennessee, 37404

  • IHA Hematology Oncology Consultants-Chelsea

    Chelsea, Michigan, 48118

  • Saint Joseph Mercy Chelsea

    Chelsea, Michigan, 48118

  • Cheyenne Regional Medical Center-West

    Cheyenne, Wyoming, 82001

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Illinois

    Chicago, Illinois, 60612

  • Presence Resurrection Medical Center

    Chicago, Illinois, 60631

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Enloe Medical Center

    Chico, California, 95926

  • Adventist Health Cancer Care Center Chico

    Chico, California, 95973

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Ascension Calumet Hospital

    Chilton, Wisconsin, 53014

  • Marshfield Clinic-Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • Oncology Hematology Care Inc-Eden Park

    Cincinnati, Ohio, 45202

  • Oncology Hematology Care Inc-Mercy West

    Cincinnati, Ohio, 45211

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • University of Cincinnati/Barrett Cancer Center

    Cincinnati, Ohio, 45219

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • Oncology Hematology Care Inc-Anderson

    Cincinnati, Ohio, 45230

  • Oncology Hematology Care Inc-Kenwood

    Cincinnati, Ohio, 45236

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • Oncology Hematology Care Inc-Blue Ash

    Cincinnati, Ohio, 45242

  • TriHealth Cancer Institute-Westside

    Cincinnati, Ohio, 45247

  • TriHealth Cancer Institute-Anderson

    Cincinnati, Ohio, 45255

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

  • MidMichigan Medical Center - Clare

    Clare, Michigan, 48617

  • Hematology Oncology Consultants-Clarkston

    Clarkston, Michigan, 48346

  • McLaren Cancer Institute-Clarkston

    Clarkston, Michigan, 48346

  • Newland Medical Associates-Clarkston

    Clarkston, Michigan, 48346

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Wake Forest University at Clemmons

    Clemmons, North Carolina, 27012

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina, 28328

  • Prisma Health Cancer Institute - Laurens

    Clinton, South Carolina, 29325

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan, 48038

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • AdventHealth Infusion Center Haywood

    Clyde, North Carolina, 28721

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

  • Kootenai Medical Center

    Coeur d'Alene, Idaho, 83814

  • Coffeyville Regional Medical Center

    Coffeyville, Kansas, 67337

  • Main Line Health Center-Collegeville

    Collegeville, Pennsylvania, 19426

  • Integrity Oncology PLLC-Collierville

    Collierville, Tennessee, 38017

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

  • Memorial Hospital North

    Colorado Springs, Colorado, 80920

  • University of Missouri - Ellis Fischel

    Columbia, Missouri, 65212

  • John B Amos Cancer Center

    Columbus, Georgia, 31904

  • Baptist Memorial Hospital and Cancer Center-Golden Triangle

    Columbus, Mississippi, 39705

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Mount Carmel East Hospital

    Columbus, Ohio, 43213

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Grant Medical Center

    Columbus, Ohio, 43215

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • New Hampshire Oncology Hematology PA-Concord

    Concord, New Hampshire, 03301

  • MD Anderson in The Woodlands

    Conroe, Texas, 77384

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

  • Baptist Health Corbin

    Corbin, Kentucky, 40701

  • Commonwealth Cancer Center-Corbin

    Corbin, Kentucky, 40701

  • Alegent Health Mercy Hospital

    Council Bluffs, Iowa, 51503

  • Mary Bird Perkins Cancer Center - Covington

    Covington, Louisiana, 70433

  • Northshore Oncology Associates-Covington

    Covington, Louisiana, 70433

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • Oncology Hematology Care Inc-Crestview

    Crestview Hills, Kentucky, 41017

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

  • Western Maryland Regional Medical Center

    Cumberland, Maryland, 21502

  • Northside Hospital-Forsyth

    Cumming, Georgia, 30041

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • Baylor University Medical Center

    Dallas, Texas, 75246

Other trials in United States

Canada21 sites

  • BCCA-Abbotsford Cancer Centre

    Abbotsford British Columbia, British Columbia, V2S 1K2

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

  • Western Manitoba Cancer Centre-Brandon

    Brandon, Manitoba, R7A 2B3

  • Cambridge Memorial Hospital

    Cambridge, Ontario, N1R 3G2

  • Everett Chalmers Hospital

    Fredericton, New Brunswick, E3B 5N5

  • Health Sciences North

    Greater Sudbury, Ontario, P3E 5J1

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7

  • Grand River Regional Cancer Centre at Grand River Hospital

    Kitchener, Ontario, N2G 1G3

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • The Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8

  • Stronach Regional Health Centre at Southlake

    Newmarket, Ontario, L3Y 2P9

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Niagara Health System-Saint Catharines General

    Saint Catharines, Ontario, L2S 0A9

  • Atlantic Health Sciences Corporation-Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Doctor H. Bliss Murphy Cancer Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • North York General Hospital

    Toronto, Ontario, M2K 1E1

  • Odette Cancer Centre- Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

  • University Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • BCCA-Vancouver Island Cancer Centre

    Victoria, British Columbia, V8R 6V5

Other trials in Canada

Puerto Rico12 sites

  • Advance Oncology Center

    Aguadilla, 00603

  • Doctor's Cancer Center-Arecibo

    Arecibo, 00614

  • Cancer Center-Metro Medical Center Bayamon

    Bayamón, 00959-5060

  • Hematologia Oncologia San Pablo

    Bayamón, 00961

  • HIMA San Pablo Oncologic Hospital

    Caguas, 00726

  • Doctors Cancer Center

    Manati, 00674

  • Instituto Oncologia Moderna Ponce

    Ponce, 00716

  • San Juan Community Oncology Group

    San Juan, 00917

  • Primary Care Physician Group

    San Juan, 00920

  • Centro Comprensivo de Cancer de UPR

    San Juan, 00927

  • San Juan City Hospital

    San Juan, 00936

  • Centro de Hematologia y Oncologia del Sur

    Santa Isabel, 00757

Other trials in Puerto Rico

Guam1 site

  • FHP Health Center-Guam

    Tamuning, 96913

Other trials in Guam

About this study

Official title: Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women With Early Breast Cancer

This randomized phase III trial compares 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.

Read the 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:
  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.

Being tested
Health Education Program, Weight Loss Intervention
Medical subject headings
Carcinoma, Intraductal, Noninfiltrating, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health Education ProgramOther

  • Weight Loss InterventionOther

Study groups in NCT02750826
Study groupRoleWhat they receive
Arm 1: Health Education ProgramOtherPatients will receive a standardized intervention focusing on healthy living. This will include mailings at study entry and one year later describing healthy lifestyle behaviors. All participants will also receive a 2-year subscription to a health magazine. In addition, all study participants will be invited to join twice-yearly Webinars/teleconferences that focus on breast cancer and other health topics, such as treatment updates in breast cancer, management of menopausal side effects, general cancer screening, etc. Finally, the study will also provide birthday and holiday greeting cards and a twice-yearly study newsletter with study updates and other general breast cancer news.
Receives: Other: Health Education Program
Arm 2: Health Education Program + Weight Loss InterventionOtherPatients will receive a standardized intervention focusing on healthy living as described in the Arm 1 (Health Education Program). In addition, patients will utilize a standardized, 2-year, telephone-based weight loss intervention. The intervention will include individual weight loss, caloric restriction, and physical activity goals for each participant. It will be administered through semi-structured phone calls delivered by trained coaches at the BWEL call center and supplemented through print and on-line materials. The intervention will utilize a toolbox approach that will allow for tailoring for the individual participant.
Receives: Other: Health Education Program; Other: Weight Loss Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Invasive disease-free survival

    Measured: Up to 10 years

Secondary outcomes (22)

  1. Overall survival

    Measured: Up to 10 years

  2. Distant disease-free survival

    Measured: Up to 10 years

  3. Change in weight (defined as % change)

    Measured: At baseline, 6, 12, 24 and 60 months

  4. Measures of physical activity (self report and objective)

    Measured: Up to 10 years

  5. Dietary intake (total calorie consumption)

    Measured: Up to 10 years

  6. Occurrence of insulin resistance syndrome complications (diabetes, hospitalizations for cardiovascular disease)

    Measured: Up to 10 years

  7. Changes in biomarker (insulin) associated with breast cancer risk and outcomes

    Measured: Up to 10 years

  8. Changes in biomarker (glucose) associated with breast cancer risk and outcomes

    Measured: Up to 10 years

  9. Changes in biomarker (HOMA) associated with breast cancer risk and outcomes

    Measured: Up to 10 years

  10. Changes in biomarker (leptin) associated with breast cancer risk and outcomes

    Measured: Up to 10 years

  11. Changes in biomarker (adiponectin) associated with breast cancer risk and outcomes

    Measured: Up to 10 years

  12. Changes in biomarker (IGF-1) associated with breast cancer risk and outcomes

    Measured: Up to 10 years

  13. Changes in biomarker (IGFBP3) associated with breast cancer risk and outcomes

    Measured: Up to 10 years

  14. Changes in biomarker (IL-6) associated with breast cancer risk and outcomes

    Measured: Up to 10 years

  15. Changes in biomarker (CRP) associated with breast cancer risk and outcomes

    Measured: Up to 10 years

  16. Changes in biomarker (TNF-a) associated with breast cancer risk and outcomes

    Measured: Up to 10 years

  17. Patient reported outcomes - physical functioning

    Measured: Up to 10 years

  18. Patient reported outcomes - fatigue

    Measured: Up to 10 years

  19. Patient reported outcomes - depression and anxiety

    Measured: Up to 10 years

  20. Patient reported outcomes - sleep disturbance

    Measured: Up to 10 years

  21. Patient reported outcomes - incidence of breast cancer treatment related symptoms

    Measured: Up to 10 years

  22. Patient reported outcomes - body image

    Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2016 (estimated)
  2. Study start16 Sep 2016
  3. Primary completion30 May 2030 (estimated)
  4. Study completion30 May 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,177 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02750826
Sponsor's protocol ID
A011401
Other IDs
NCI-2015-01918, U10CA180821
Status last verified
Aug 2026
First submitted
19 Apr 2016
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No

Publications

  • Liu Y, Xu S, Yang H, Wang Y. Multidimensional risk impact of obesity on breast cancer incidence, treatment, and prognosis. Int J Obes (Lond). 2026 Jun;50(6):1190-1198. doi: 10.1038/s41366-025-02008-9. Epub 2026 Jan 12.

    PubMed 41526462

  • Ligibel JA, Ballman KV, McCall L, Goodwin PJ, Alfano CM, Bernstein V, Crane TE, Delahanty LM, Frank E, Hahn O, Hershman DL, Hopkins JO, Irwin M, Mayer EL, Minasian L, Nebeling L, Neuhouser ML, Paskett ED, Spears PA, Stearns V, Thomson CA, Weiss A, White J, Wadden TA, Winer EP, Hudis C, Partridge AH, Carey LA. Impact of a Weight Loss Intervention on 1-Year Weight Change in Women With Stage II/III Breast Cancer: Secondary Analysis of the Breast Cancer Weight Loss (BWEL) Trial. JAMA Oncol. 2025 Oct 1;11(10):1194-1203. doi: 10.1001/jamaoncol.2025.2738.

    PubMed 40839373

  • Shaikh H, Bradhurst P, Ma LX, Tan SYC, Egger SJ, Vardy JL. Body weight management in overweight and obese breast cancer survivors. Cochrane Database Syst Rev. 2020 Dec 11;12(12):CD012110. doi: 10.1002/14651858.CD012110.pub2.

    PubMed 33305350

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Health Education Program and Weight Loss Intervention in people with Breast Ductal Carcinoma In Situ and Invasive Breast Carcinoma, run by Alliance for Clinical Trials in Oncology at 1,498 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1,498 sites in United States, Canada, Puerto Rico, Guam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Invasive disease-free survival (time frame: Up to 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02750826, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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