Physical Activity, Proliferation and Immune Markers in Benign Breast Tissue

NCT03657628 | Active Not Recruiting

• 2 other identifiers: 18-168P50CA168504
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is evaluating the effect of exercise on markers in breast tissue and blood of premenopausal women who have been found to have dense breast tissue on mammogram.

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Impact of exercise upon expression of Ki-67

  To evaluate the change in breast tissue expression of Ki-67 in premenopausal women with increased breast density taking part in a 12-week physical activity intervention

  12-weeks

Secondary Outcomes (6)

• Changes in biomarker (IL-6)

  12-weeks

• Changes in biomarker (TNF-a)

  12-weeks

• Changes in biomarker (CRP)

  12-weeks

• Changes in minutes of weekly physical activity

  12-weeks

• Changes in waist to hip ratio

  12-weeks

Study Arms (1)

Physical activity

EXPERIMENTAL

* The exercise intervention will consist of a supervised, moderate-intensity aerobic exercise program. * Will receive social/behavioral support * Will receive research staff contact time to encourage them to increase their physical activity level * The participants will be given the option of a third supervised session each week

Other: Exercise Intervention

Interventions

Exercise Intervention OTHER

Strength training and moderate-intensity, aerobic exercise

Physical activity

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent prior to any study-related procedures
• Premenopausal women, defined as:
• having regular menstrual cycles
• age ≤ 50 years with an intact IUD
• history of hysterectomy without oophorectomy
• Heterogeneously dense or very dense (BIRADS 3 or 4) breast tissue on mammogram within the last 3 years
• Physically inactive; engaging in \<90 minutes of moderate or vigorous intensity PA per week
• No prior history of breast cancer
• At least 18 years old
• Physically able to exercise
• English speaking and able to read English

You may not qualify if:

• 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 contraceptives; Mirena IUD is acceptable
• Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. 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)

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jennifer Ligibel, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: September 5, 2018
• Study Start: September 17, 2018
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)