NCT07066189Recruiting
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)
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 24 Jun 2025
- Start date
- Oct 2025
- Primary completion date
- Oct 2029
- Lead sponsor
- Yale University
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT07066189
What you commit to
- Study type: Interventional
- Planned participants: 160
- From Oct 2025 to the primary completion date, Oct 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Having already started a 2nd chemotherapy cycle.
Other illness
- Presence of dementia or major psychiatric disease.
- Recent (past year) stroke, myocardial infarction, or congestive heart failure.
Other
- Pregnancy or intention to become pregnant.
Who the study is looking for
- Female aged 18 years or older.
- Have a diagnosis of stage II or III Triple Negative Breast Cancer (TNBC).
- Be scheduled to receive neoadjuvant chemo-immunotherapy.
- Be physically able to walk.
- Be able to complete forms, understand instructions and read in English.
- Agree to be randomly assigned to either group.
- Have clearance from oncologist to participate.
- Not exercising (less than 150 min/week).
- Not consuming more than 7 fruits and vegetable/day.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.