Lifestyle, Exercise, And Nutrition (LEAN) Trial on Pathologic Complete Response in TNBC
Lifestyle, Exercise, And Nutrition (LEAN) Trial on Pathologic Complete Response in Triple Negative Breast Cancer (TNBC)
- Triple Negative Breast Cancer
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- Yale University
- Enrolment target
- 160
- Started
- 17 October 2025
- Main results due
- October 2029
- Study sites
- 1
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Women only.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
Yale University
New Haven, Connecticut, United States
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07066189. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
Not the right study?
Answer three questions and see the studies recruiting near you, in plain language.
Find a study for me