Actively Recruiting
Lifestyle, Exercise, And Nutrition (LEAN) Trial on Pathologic Complete Response in TNBC
Led by Yale University · Updated on 2025-10-29
160
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
B
Breast Cancer Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Lifestyle, Exercise, And Nutrition (LEAN) Trial on Pathologic Complete Response in TNBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older
- Diagnosis of stage II or III Triple Negative Breast Cancer (TNBC)
- Scheduled to receive neoadjuvant chemo-immunotherapy
- Physically able to walk
- Able to complete forms, understand instructions, and read in English
- Agree to be randomly assigned to either group
- Clearance from oncologist to participate
- Exercising less than 150 minutes per week
- Consuming fewer than 7 servings of fruits and vegetables per week
You will not qualify if you...
- Started a second chemotherapy cycle
- Pregnant or intending to become pregnant
- Presence of dementia or major psychiatric disease
- Recent (past year) stroke, myocardial infarction, or congestive heart failure
AI-Screening
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Trial Site Locations
Total: 1 location
1
Yale University
New Haven, Connecticut, United States, 06511
Actively Recruiting
Research Team
M
Melinda Irwin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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