Recruiting

Exercise TrainingResistance and Aerobic Exercise for Prevention in Women With Dense Breasts (REP-D)

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT06322888

Conditions

Breast Cancer

Breast Cancer Female

Eligibility Criteria

Sex: Female

Age: 18 - 59

Healthy Volunteers: Accepted

Interventions

Exercise Training Program

Study Details

Brief summary:

The goal of this study is to learn more about how exercise might lower the risk of developing breast cancer in women with dense breast tissue by studying changes that occur in breast tissue and blood as a result of participating in an exercise program.

The names of the study groups in this study are:

Exercise Training Group
Waitlist Control Group

Conditions

Breast Cancer

Breast Cancer Female

Study ID

NCT06322888

Start date

Mar 28, 2024

Status verified date

Nov, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 59

Healthy Volunteers: Accepted

Inclusion Criteria:

Women aged 18-59
Heterogeneously dense/extremely dense (BIRADS 3 or 4) breast tissue on mammogram within the past 12 months
Physically inactive; engaging in <60 minutes of moderate or vigorous intensity exercise per week, as assessed by Godin Leisure Time screener
Not pregnant or breastfeeding
English speaking and able to read English. Investigators are only enrolling English-speaking participants to this study at this time due to the fact that investigators currently only have English-speaking exercise trainers with the proper qualifications to conduct the exercise training
Written informed consent prior to any study-related procedures

Exclusion Criteria:

Self-reported inability to walk 2 blocks (at any pace)
Prior history of breast cancer; prior DCIS is allowable as long as participant is not taking endocrine therapy and has at least 1 breast that has not been irradiated
On oral or implantable hormonal contraceptives, postmenopausal hormone replacement therapy, a selective estrogen receptor modulator or an aromatase inhibitor; Mirena or other IUD is acceptable
Consistent strength training in the past 3 months
Use of weightloss drugs
Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate exercise. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility
Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder)

Study Design

Enrollment

46 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Arm A: Exercise Intervention

Participants will be randomized and will complete:

Baseline study visit with assessments, breast biopsy, and blood draw.
Exercise program for 12 weeks 3x weekly and exercise logs. Additional blood draw after first exercise session.
End of study visit with assessments, breast biopsy, and blood draw.

no intervention: Arm B: Waitlist Control

Participants will be randomized and will complete:

Baseline study visit with assessments, breast biopsy, and blood draw.
End of study visit with assessments, breast biopsy, and blood draw.
Participants will be offered a complimentary 12-week exercise program after completing the study.

Interventions

Exercise Training Program

A 12-week aerobic and resistance-training exercise intervention with a certified exercise trainer in person or virtually. FitBit activity tracker, resistance bands, hand weights, and stationary bike will be provided to participants. Hand weights will be returned at end of study.

Primary outcome measure

Change in Irisin in Exercise Group [ Time Frame: At baseline, within 2 hours of 1st exercise session, and at week 12, up to 16 weeks ]
Change in Irisin in Control Group [ Time Frame: At baseline and week 12, up to 16 weeks ]

Central Contacts and Locations

Central contacts

Jennifer Ligibel, MD

617-632-3800 jennifer_ligibel@dfci.harvard.edu

Anna Tanasijevic, MPH

617-632-5584 anna_tanasijevic@dfci.harvard.edu

Locations

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Jennifer Ligibel, MD

617-632-3800 Jennifer_Ligibel@dfci.harvard.edu

Principal Investigator:

Jennifer Ligibel, MD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Nov 21, 2025

Last verified

Nov, 2025

Keywords

Breast Cancer
Breast Cancer Female
Breast Cancer Risk
Dense breast tissue
Dense breasts

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2025-11-21.