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RECRUITING Not applicable ClinicalTrials.gov

Lifestyle, Exercise, And Nutrition (LEAN) Trial on Pathologic Complete Response in TNBC

Sponsor: Yale University • ClinicalTrials.gov ID: NCT07066189

Registry updated: 2026-09-25
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Description

The purpose of this study is to examine whether a nutrition and exercise program can improve pathologic complete response (pCR) in women with triple-negative breast cancer (TNBC) receiving chemo-immunotherapy before surgery. Pathologic complete (pCR) response means that no cancer in the breast is seen after chemotherapy.

Interventions

  • Exercise and Medical Nutrition (Behavioral)
    10, 30-minute sessions spread out over the course of their neoadjuvant therapy and in the weeks leading up to surgery. On weeks counseling is not scheduled an exercise session will be observed.

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/day. 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.

Conditions

Triple Negative Breast Cancer

Locations

  • Yale University — New Haven, Connecticut, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record