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Lifestyle, Exercise, And Nutrition (LEAN) Trial on Pathologic Complete Response in TNBC

NCT07066189 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-10-29

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Exercise and Medical Nutrition

10, 30-minute sessions spread out over the course of their neoadjuvant therapy and in the weeks leading up to surgery. On weeks counseling is not scheduled an exercise session will be observed.

Sponsors & Collaborators

  • Breast Cancer Research Foundation

    collaborator OTHER

  • Yale University

    lead OTHER

Principal Investigators

  • Melinda Irwin · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-17
Primary Completion
2029-10-31
Completion
2029-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07066189 on ClinicalTrials.gov