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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

Must not have

No prior bariatric surgery or planning to undergo this procedure within the next 2 years after study registration

History of any lymphoproliferative disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

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.

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.

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 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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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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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had, nor plan to have, weight-loss surgery in the next 2 years.

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I have had a condition where my lymphocytes grow abnormally.

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I do not have any health conditions that would shorten my life to under 5 years.

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I have a history of cancer.

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My cancer has not spread to other parts of my body.

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I do not take insulin or sulfonylureas for diabetes.

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I do not have serious digestive problems that would stop me from following a study diet.

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I don't have severe heart, lung, or muscle diseases that stop me from doing moderate exercise.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

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