NCT07066189

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
41mo left

Started Oct 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Oct 2025Oct 2029

First Submitted

Initial submission to the registry

June 24, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

October 17, 2025

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Last Updated

October 29, 2025

Status Verified

October 1, 2025

Enrollment Period

4 years

First QC Date

June 24, 2025

Last Update Submit

October 27, 2025

Conditions

Triple Negative Breast Cancer

Keywords

ExerciseDietPathologic complete responseNeoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

  • Pathologic Complete Response (pCR)

    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)

    Post breast cancer surgery, an average of 6 months

Secondary Outcomes (1)

  • Residual Cancer Burden (RCB)

    Post breast cancer surgery, an average of 6 months

Other Outcomes (10)

  • Healthy Eating Index (HEI)

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

  • Physical activity

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

  • Patient reported toxicities

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

  • +7 more other outcomes

Study Arms (2)

Exercise and Medical Nutrition

EXPERIMENTAL

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.

Behavioral: Exercise and Medical Nutrition

Usual care

NO INTERVENTION

Contact limited to study assessments.

Interventions

Exercise and Medical NutritionBEHAVIORAL

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.

Exercise and Medical Nutrition

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast NeoplasmsMotor ActivityPathologic Complete Response

Interventions

Exercise

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehaviorDisease ProgressionDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Melinda Irwin

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Melinda Irwin

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The following study personnel will be masked to participant study arm: the staff performing DXA scan and blood processing/biomarker evaluation. The staff performing clinic measures, study staff reviewing forms and entering data, the PI and Co-Is, the statistician, study manager, and interventionists will be unblinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2025

First Posted

July 15, 2025

Study Start

October 17, 2025

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2029

Last Updated

October 29, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)