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

NCT ID: NCT06322888

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-28
• Study Completion Date: 2026-12-31

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

Detailed Description

The goal of this study is to learn more about how exercise might lower the risk of developing breast cancer by studying changes that occur in breast tissue and blood as a result of participating in an exercise program. Participants will be placed into one of two study groups: Exercise Training Group vs. Waitlist Control Group. Randomization means that a participant is put into a group by chance.

The research study procedures include screening for eligibility and baseline and end of study assessments which include: breast biopsies, assessment of physical activity habits, aerobic and strength testing, blood draws and questionnaires.

Participants randomized to the exercise group will be expected to participate in exercise sessions throughout the study. They will also be asked to complete logs of their activity.

Participants will be in this research study for up to 16 weeks.

It is expected that 46 women will take part in this study.

The Breast Cancer Research Foundation is supporting this research study by providing funding.

Conditions

Breast Cancer; Breast Cancer Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise Training Program

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Breast Cancer Research Foundation

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Jennifer A. Ligibel, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Ligibel, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: ACTIVE_NOT_RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jennifer Ligibel, MD

Role: CONTACT

jennifer_ligibel@dfci.harvard.edu

617-632-3800

Anna Tanasijevic, MPH

Role: CONTACT

anna_tanasijevic@dfci.harvard.edu

617-632-5584

Facility Contacts

Jennifer Ligibel, MD

Role: primary

Jennifer_Ligibel@dfci.harvard.edu

617-632-3800

Other Identifiers

23-676

Identifier Type: -

Identifier Source: org_study_id