Recruiting

Nutrition & Exercise

Sponsor:

Yale University

Code:

NCT07066189

Conditions

Triple Negative Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise and Medical Nutrition

Study Details

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.

Conditions

Triple Negative Breast Cancer

Study ID

NCT07066189

Start date

Oct 17, 2025

Status verified date

Oct, 2025

Completion date

Oct, 2029

Anticipated

Primary completion date

Oct, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Exercise and Medical Nutrition

Women randomized to the intervention will receive 10, 30-minute sessions spread out over the course of their neoadjuvant therapy and in the weeks leading up to surgery. In weeks in which one of the 10 counseling sessions is not scheduled the interventionist will observe the participant in an exercise session via zoom, or check in with the participant by phone regarding their exercise. The intervention will continue until the day prior to the last chemotherapy infusion.

no intervention: Usual care

Contact limited to study assessments.

Interventions

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.

Primary outcome measure

  • Pathologic Complete Response (pCR) [ Time Frame: Post breast cancer surgery, an average of 6 months ]

Central Contacts and Locations

Central contacts

Melinda Irwin

203-785-6392melinda.irwin@yale.edu

Locations

Yale University

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

Melinda Irwin, PhD

203-785-6392melinda.irwin@yale.edu

More Information

Sponsor

Yale University

Last update posted

Oct 29, 2025

Last verified

Oct, 2025

Keywords

  • Exercise
  • Diet
  • Pathologic complete response
  • Neoadjuvant therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2025-10-29.