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Breast Cancer WEight Loss Study (BWEL Study)

StatusActive, Not Recruiting
PhasePhase 3
Started2016-09-16
View on ClinicalTrials.gov ↗

Amendment history

2026-08-31
Study Identification, Study Status, Oversight, Study Description, Conditions, Eligibility, IPDSharing v47
Eligibility criteria-239 characters
[...] d invasive breast cancer and registration must occur within 1416 months after the first histologic diagnosis of invasive bre [...] or the study. Bilateral breast carcinoma is allowed provided either: diagnoses are synchronous - that is, within 3 months of one [...] 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 1.2 Her-2 negative, defined as: In-situ hybridization (ISH) rati [...] d) Deemed to not be a candidate for Her [...]
2025-01-09
Study Identification, Study Status, Oversight, Contacts/Locations, IPDSharing v46
Primary completion date2030-05→2030-05-30
Completion datenot stated→2030-05-30
Start date2016-08→2016-09-16
Study sitesdetails revised at 3 of 1498 sites
2023-08-30
2 amendments v44-v45
2 re-verifications since 2021-11-11, no change to tracked fields
2021-03-05
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v43
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 3136→confirmed 3177
Study sites1498 entries, revised
LakeNovant NormanHealth HematologyCancer OncologyInstitute Specialists- Huntersville LakeNovant NormanHealth HematologyCancer OncologyInstitute Specialists- Mooresville CarolinaNovant OncologyHealth AssociatesCancer PAInstitute - Rowan Aspirus UW Cancer CenterCare - Wisconsin Rapids
2021-02-05
Study Status, Contacts/Locations v42
Study sites1487→1498
Show 41 earlier versions
2021-01-08
Study Status, Contacts/Locations v41
Study sites1484→1487
2020-12-08
Study Status, Contacts/Locations v40
Study sites1482→1484
2020-11-10
Study Status, Contacts/Locations v39
Study sites1478→1482
2020-10-08
Study Status, Contacts/Locations v38
Study sites1467→1478
2020-07-22
Study Status, Contacts/Locations v37
Study sites1456→1467
2020-06-03
Study Status, Contacts/Locations v36
Study sites1456 entries, revised
Fairview- Southdale Hospital Fairview Clinics and Surgery Center Maple Grove Medical Center
2020-05-06
Study Status, Contacts/Locations v35
Study sites1451→1456
2020-03-04
Study Status, Contacts/Locations v34
Study sites1447→1451
2020-02-04
Study Status, Contacts/Locations v33
Study sites1440→1447
2020-01-07
Study Status, Contacts/Locations v32
Study sites1435→1440
2019-11-19
Study Status, Contacts/Locations v31
Study sites1429→1435
2019-10-21
Study Status, Contacts/Locations v30
Study sites1419→1429
2019-09-18
Study Status, Contacts/Locations v29
Study sites1395→1419
2019-08-02
Study Status, Contacts/Locations v28
Study sites1385→1395
2019-06-18
Study Status, Contacts/Locations v27
Study sites1373→1385
2019-05-14
Study Status, Contacts/Locations v26
Study sites1353→1373
2019-03-19
Study Status, Eligibility v25
Eligibility criteria+28 characters
[...] d invasive breast cancer and registration must occur within 1214 months after the first histologic diagnosis of invasive bre [...] ER and/or PR on IHC): T0-3N1-3 or T3N0. Note: Patients with T1-2T0N0, N1miT1N0, T2N0 or T1N1mi and T2N1mi disease are NOT eligible. The eligibility of neo-adjuvant subjects can be assessed on [...]
2019-02-19
Study Status, Contacts/Locations v24
Study sites1337→1353
2019-01-22
Study Status, Contacts/Locations v23
Study sites1309→1337
2018-12-04
Study Status, Sponsor/Collaborators v22
Collaborators3 to 4 entries
Canadian Cancer Trials Group
2018-09-05
Study Status, Contacts/Locations v21
Study sites1303→1309
2018-08-06
Study Status, Contacts/Locations v20
Study sites1290→1303
2018-07-16
Study Status, Contacts/Locations v19
Study sites1281→1290
2018-06-08
Study Status, Contacts/Locations v18
Study sites1266→1281
2018-05-04
Study Status, Contacts/Locations v17
Study sites1262→1266
2018-04-06
Study Status, Contacts/Locations v16
Study sites1252→1262
2018-03-06
Study Status, Contacts/Locations v15
Study sites1234→1252
2018-02-05
Study Status, Contacts/Locations v14
Study sites1224→1234
2018-01-12
Study Status, Contacts/Locations v13
Study sites1153→1224
2017-09-29
Study Status, Contacts/Locations v12
Study sites1132→1153
2017-08-15
Study Status, Contacts/Locations v11
Study sites1098→1132
2017-06-20
Study Status, Contacts/Locations v10
Study sites1076→1098
2017-05-24
Study Status, Contacts/Locations v9
Study sites1056→1076
2017-04-19
Study Status, Contacts/Locations v8
Study sites989→1056
2017-03-03
Study Status, Contacts/Locations v7
Study sites890→989
2017-02-17
Study Status, Oversight, Eligibility v6
Eligibility criteria+1,527 characters
[...] nce of clinical T4 disease prior to chemotherapy and surgery. See; eligibility for neoadjuvant patients can be defined by either clinical stage prior to therapy or pathologic stage at surgery; if patient is eligible cTNMbased classificationson beloweither, they are eligible for the study. Bilateral breast carcinoma is allowed provided diagnoses a [...] breast carcinomas meet the eligibility criteria and neither violatesHer-2 thepositive eligibilityor criteriainflammatory. No evidence of metastatic disease 1.2 Her-2 negative, defined as: In-situ hybridization (ISH) [...] not be a candidate for Her-2 directe [...]
2017-01-27
Study Status, Conditions v5
Re-verified, no change to tracked fields
2017-01-24
Study Status, Contacts/Locations v4
Study sites729→890
2016-11-16
Study Status, Contacts/Locations v3
Study sites1→729
2016-08-29
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
2016-05-13
Study Status, Contacts/Locations v1
Re-verified, no change to tracked fields
2016-04-21
Original filing
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.
Trial Details
NCT Number NCT02750826
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI), Division of Cancer Control, NIH Biomarker, Imaging and Quality of Life Studies Funding Program (BIQSFP), Canadian Cancer Trials Group
Conditions Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma, Stage II Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7, Synchronous Bilateral Breast Carcinoma
Enrollment 3,177 participants
Start Date 2016-09-16
Primary Completion 2030-05-30 (estimated)
Study Completion 2030-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-02