NCT07066189 Lifestyle, Exercise, And Nutrition (LEAN) Trial on Pathologic Complete Response in TNBC
| NCT ID | NCT07066189 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yale University |
| Condition | Triple Negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-10-17 |
| Primary Completion | 2029-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2025-10-17 with a primary completion date of 2029-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Melinda Irwin
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT07066189 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Triple Negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07066189 currently recruiting?
Yes, NCT07066189 is actively recruiting participants. Contact the research team at melinda.irwin@yale.edu for enrollment information.
Where is the NCT07066189 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT07066189 clinical trial?
NCT07066189 is sponsored by Yale University. The principal investigator is Melinda Irwin at Yale University. The trial plans to enroll 160 participants.
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