Lifestyle, exercise, and nutrition program to improve response in triple-negative breast cancer

Lifestyle, Exercise, And Nutrition (LEAN) Trial on Pathologic Complete Response in Triple Negative Breast Cancer (TNBC)

This will test whether weekly remote nutrition counseling and a home-based exercise program can help women with stage II–III triple-negative breast cancer have no remaining tumor in the breast after chemo-immunotherapy before surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Yale University (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (New Haven, Connecticut)
• Trial ID: NCT07066189 on ClinicalTrials.gov

What this trial studies

This randomized interventional study enrolls women with stage II–III triple-negative breast cancer who are scheduled for neoadjuvant chemo-immunotherapy and currently do less than 150 minutes of exercise per week. After baseline assessment and consent, participants are randomly assigned to weekly 30-minute remote nutrition and exercise counseling plus a home-based exercise regimen or to usual care for the duration of chemotherapy. Study visits include two in-person assessments with blood draws, a 6-minute walk test, and DXA scans to measure body composition. The primary outcome is pathologic complete response (no residual cancer in the breast) with secondary outcomes including residual cancer burden, treatment-related symptoms, body composition, and blood biomarkers.

Who should consider this trial

Good fit: Women aged 18 or older with stage II–III triple-negative breast cancer who are scheduled for neoadjuvant chemo-immunotherapy, can walk, read English, obtain oncologist clearance, agree to randomization, and currently do less than 150 minutes of exercise per week and low fruit/vegetable intake are the intended participants.

Not a fit: Patients who have already started a second cycle of chemotherapy, are pregnant or planning pregnancy, have dementia or major psychiatric disease, or recent major cardiac or cerebrovascular events, or who already meet high activity and nutrition levels may not be eligible or likely to benefit.

Why it matters

Potential benefit: If successful, the program could increase the chance of a pathologic complete response and improve fitness, body composition, and treatment-related symptoms.

How similar studies have performed: Previous exercise and nutrition programs in cancer patients have improved fitness, body composition, and some treatment-related symptoms, but applying a combined program specifically to increase pathologic complete response in neoadjuvant TNBC is largely novel.

Eligibility criteria

Inclusion Criteria:

1. Female aged 18 years or older.
2. Have a diagnosis of stage II or III Triple Negative Breast Cancer (TNBC).
3. Be scheduled to receive neoadjuvant chemo-immunotherapy.
4. Be physically able to walk.
5. Be able to complete forms, understand instructions and read in English.
6. Agree to be randomly assigned to either group.
7. Have clearance from oncologist to participate.
8. Not exercising (less than 150 min/week).
9. Not consuming more than 7 fruits and vegetable/week.

Exclusion Criteria:

1. Having already started a 2nd chemotherapy cycle.
2. Pregnancy or intention to become pregnant.
3. Presence of dementia or major psychiatric disease.
4. Recent (past year) stroke, myocardial infarction, or congestive heart failure.

Where this trial is running

New Haven, Connecticut

• Yale University — New Haven, Connecticut, United States (RECRUITING)

Study contacts

• Principal investigator: Melinda Irwin — Yale University
• Study coordinator: Melinda Irwin

Conditions: Triple Negative Breast Cancer, Exercise, Diet, Pathologic complete response, Neoadjuvant therapy