Lifestyle, Exercise, And Nutrition (LEAN) Trial on Pathologic Complete Response in TNBC
Launched by YALE UNIVERSITY · Jul 3, 2025
Trial Information
Current as of July 23, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether a special program of nutrition and exercise can help women with triple-negative breast cancer (a type of breast cancer that is more aggressive) respond better to treatment before surgery. Specifically, the study wants to see if this program can increase the chances that no cancer is found in the breast after chemotherapy and immunotherapy, which is called a “pathologic complete response” or pCR. Achieving pCR is a good sign because it means the treatment has worked very well.
Women who might join this study need to be 18 or older, have stage II or III triple-negative breast cancer, and be about to start chemotherapy combined with immunotherapy before surgery. They should be physically able to walk and not regularly exercising more than 150 minutes a week or eating many fruits and vegetables (more than 7 servings per week). Participants will be randomly placed into one of two groups—one with the nutrition and exercise program and one without—to compare the differences. They will also need approval from their cancer doctor to take part. The study is not yet enrolling participants but aims to help understand if lifestyle changes can support cancer treatment.
Gender
FEMALE
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.
About Yale University
Yale University, a prestigious Ivy League institution located in New Haven, Connecticut, is renowned for its commitment to advancing medical research and clinical innovation. With a rich history of academic excellence and a robust infrastructure for scientific inquiry, Yale serves as a leading sponsor for clinical trials aimed at improving patient care and developing new therapeutic approaches. The university's multidisciplinary teams of researchers and clinicians collaborate to conduct rigorous and ethical studies, leveraging cutting-edge technologies and methodologies to address critical health challenges. Through its dedication to fostering an environment of inquiry and discovery, Yale University plays a pivotal role in translating research findings into clinical practice, ultimately enhancing health outcomes for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New Haven, Connecticut, United States
Patients applied
Trial Officials
Melinda Irwin
Principal Investigator
Yale University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported