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NCT Number: NCT07066189

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

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.

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Key information

Conditions

Triple Negative Breast Cancer Behavior Breast Diseases Breast Neoplasms Disease Attributes Disease Progression Motor Activity Neoplasms Neoplasms by Site Pathologic Complete Response Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06511, United States

Location status: Recruiting

Location contact

Melinda Irwin, PhD

CONTACT

[email protected]

203-785-6392

About this study

Women with stage II-III triple-negative breast cancer (TNBC) undergoing neoadjuvant chemo-immunotherapy will be enrolled in the study. Following screening, consent, and baseline assessment, participants will be randomized to either the intervention group (nutrition and exercise counseling) or the usual care group. Participants randomized to the intervention group will complete weekly remote sessions with the interventionist throughout the duration of chemotherapy. Each counseling session will last about 30 minutes and will be conducted remotely. The exercise regimen is home-based.

Study activities include completing surveys and attending two in-person study visits, each of which will include a blood draw, a 6-minute walk test to assess aerobic capacity and endurance, and a Dual Energy X-Ray Absorptiometry (DXA) scan to measure body composition.

The primary outcome is the pathologic complete response.

Researchers will also compare the exercise and nutrition program to usual care to determine if the program improves residual cancer burden, symptoms related to cancer treatment, body composition, and blood biomarkers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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/week.

Exclusion criteria

  • Having already started a 2nd chemotherapy cycle.
  • Pregnancy or intention to become pregnant.
  • Presence of dementia or major psychiatric disease.
  • Recent (past year) stroke, myocardial infarction, or congestive heart failure.

Treatment and study plan

Exercise and medical nutrition

Behavioral

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.

Primary outcomes

  1. Pathologic Complete Response (pCR)

    Time frame: Post breast cancer surgery, an average of 6 months

    Pathologic Complete Response (pCR) is defined as having no invasive residual disease in the breast or regional lymph nodes after completing neoadjuvant chemotherapy (ypT0 ypN0 or ypT0/is ypN0)

Secondary outcomes

  1. Residual Cancer Burden (RCB)

    Time frame: Post breast cancer surgery, an average of 6 months

    Residual Cancer Burden (RCB) is a continuous pCR measure.

Other outcomes

  1. Healthy Eating Index (HEI)

    Time frame: Baseline to end of first line chemotherapy, on average 6 months

    Healthy Eating Index (HEI) will be will be estimated using the self-reported food frequency questionnaire developed by Fred Hutchinson Cancer Center.

  2. Physical activity

    Time frame: Baseline to end of first line chemotherapy, on average 6 months

    Self-reported minutes per week of moderate- to vigorous-intensity physical activity will be estimated using the modifiable physical activity questionnaire.

  3. Patient reported toxicities

    Time frame: Baseline to end of first line chemotherapy, on average 6 months

    Participants will be asked to complete the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) survey at baseline, 2-months, 4-months and the end of chemotherapy.

  4. Physical function

    Time frame: Baseline to end of first line chemotherapy, on average 6 months

    Participants will be asked to complete the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 survey.

  5. Fatigue

    Time frame: Baseline to end of first line chemotherapy, on average 6 months

    Participants will be asked to complete the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 survey.

  6. Neuropathy

    Time frame: Baseline to end of first line chemotherapy, on average 6 months

    Participants will be asked to complete the Functional Assessment of Cancer Therapy (FACT)-neuropathy subscale (FACT-Ntx).

  7. Malnutrition

    Time frame: Baseline to end of first line chemotherapy, on average 6 months

    Participants will be asked to complete the Patient-Generated Subjective Global Assessment (PG-SGA).

  8. Aerobic capacity

    Time frame: Baseline to end of first line chemotherapy, on average 6 months

    Participants will be asked to complete a 6-minute walk test.

  9. Lean mass

    Time frame: Baseline to end of first line chemotherapy, on average 6 months

    Participants will be asked to complete a Dual Energy X-Ray Absorptiometry (DXA) scan

  10. Percent fat

    Time frame: Baseline to end of first line chemotherapy, on average 6 months

    Participants will be asked to complete a Dual Energy X-Ray Absorptiometry (DXA) scan

Study contacts

Contact information is provided by the study sponsor or research team.

Melinda Irwin

CONTACT

[email protected]

203-785-6392

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Breast Cancer Research Foundation

Registry information

Official study title

Lifestyle, Exercise, And Nutrition (LEAN) Trial on Pathologic Complete Response in Triple Negative Breast Cancer (TNBC)

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jul 15, 2025
Registry last updated
Oct 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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