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Weight Loss Intervention for Breast Cancer Recurrence Prevention

Phase 3
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
All triple negative patients must receive chemotherapy of the treating physician's choice
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights

Study Summary

This trial tests if weight loss prevents breast cancer from recurring in overweight and obese women.

Who is the study for?
Women over 18 with invasive breast cancer diagnosed within the last 14 months, who have completed initial treatments and are overweight (BMI ≥27 kg/m2). Participants must be able to walk two blocks and read English. They should not have had other cancers in the past 4 years, severe diseases that limit life expectancy or activity, or serious digestive issues.Check my eligibility
What is being tested?
The study is testing if a weight loss program can prevent breast cancer from returning in women who were overweight at diagnosis. It compares outcomes between those following a structured weight loss intervention and those receiving standard health education.See study design
What are the potential side effects?
While this trial does not involve drugs, side effects may include typical risks associated with changing diet and exercise habits such as muscle soreness, fatigue, or nutritional deficiencies if not monitored properly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is not HER2 positive based on specific tests.
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I am receiving chemotherapy chosen by my doctor for triple-negative breast cancer.
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I can walk at least 2 blocks without help.
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My cancer was confirmed through a biopsy or during my first cancer-related surgery.
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My cancer has not spread to other parts of my body.
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I was diagnosed with invasive breast cancer less than 14 months ago.
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I must get chemotherapy for my ER/PR+ cancer unless tests show low or medium risk of it coming back with just hormone therapy.
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I have had a sentinel lymph node biopsy or axillary lymph node dissection.
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I have been on hormone therapy for breast cancer for at least 5 years.
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I am fully active or can carry out light work.
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Before my chemotherapy and surgery, my cancer had not spread to nearby tissues.
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I have cancer in both breasts, diagnosed within 3 months of each other, and at least one meets the trial's criteria.
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My cancer is HER2-negative, not suitable for HER2-targeted treatments.
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My breast cancer is at a specific stage and has certain hormone receptor characteristics.
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I haven't had invasive breast cancer in the last 5 years, except for my current diagnosis.
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I have had a mammogram of both breasts or the remaining breast if I had a mastectomy, within the last year.
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I finished all my cancer treatments like chemotherapy, radiation, and surgery over 3 weeks ago.
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I had my breast cancer surgery at least 21 days before signing up.
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My surgery removed all the invasive cancer.
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I don't have serious digestive issues that would stop me from following the study diet.
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I am 18 years old or older.
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I am a woman.
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I am a woman.
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I can walk at least 2 blocks at any pace.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Invasive disease-free survival
Secondary outcome measures
Change in weight (defined as % change)
Changes in biomarker (CRP) associated with breast cancer risk and outcomes
Changes in biomarker (HOMA) associated with breast cancer risk and outcomes
+19 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2: Health Education Program + Weight Loss InterventionExperimental Treatment2 Interventions
Patients 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.
Group II: Arm 1: Health Education ProgramExperimental Treatment1 Intervention
Patients 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.

Find a Location

Who is running the clinical trial?

NIH Biomarker, Imaging and Quality of Life Studies Funding Program (BIQSFP)UNKNOWN
Canadian Cancer Trials GroupNETWORK
122 Previous Clinical Trials
63,975 Total Patients Enrolled
9 Trials studying Breast Cancer
8,724 Patients Enrolled for Breast Cancer
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
214,457 Total Patients Enrolled
75 Trials studying Breast Cancer
40,143 Patients Enrolled for Breast Cancer

Media Library

Arm 2: Health Education Program + Weight Loss Intervention Clinical Trial Eligibility Overview. Trial Name: NCT02750826 — Phase 3
Breast Cancer Research Study Groups: Arm 2: Health Education Program + Weight Loss Intervention, Arm 1: Health Education Program
Breast Cancer Clinical Trial 2023: Arm 2: Health Education Program + Weight Loss Intervention Highlights & Side Effects. Trial Name: NCT02750826 — Phase 3
Arm 2: Health Education Program + Weight Loss Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT02750826 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many total locations is this trial currently being conducted?

"Patients are currently being enrolled at this trial's 4 primary locations: Cancer Center of Kansas - Dodge City in Dodge City, Kansas; Saint Joseph Hospital East in Lexington, Kentucky; Allegiance Health in Jackson, Michigan. In addition, there are 100 other centres where recruitment is happening."

Answered by AI

Has this medication been granted permission by the FDA for general use?

"This therapy is considered safe, as it has progressed to Phase 3 clinical trials. This suggests that not only is there evidence of its efficacy, but also that multiple rounds of testing have verified its safety."

Answered by AI

Are there any more places available for people who want to participate in this research?

"Unfortunately, this particular study is no longer actively recruiting patients. Although the original posting was on August 1st, 2016, the most recent edit was done on November 11th, 2021. That being said, there are 2,589 other trials that are still looking for participants."

Answered by AI

Who else is applying?

What site did they apply to?
Crozer-Keystone Regional Cancer Center at Broomall
Texas Tech University Health Sciences Center-Lubbock
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
~1406 spots leftby May 2030