Exercise Program for Early Breast Cancer Survivors

PRIMARY OBJECTIVES:

I. To determine whether a 16-week exercise intervention will improve components of metastasis
(MetS) in breast cancer survivors soon after completion of cancer-related treatments by
measuring changes in body composition, waist circumference, blood pressure, and serum levels
of insulin, glucose, lipids, C-reactive protein, and hemoglobin A1c (HbA1c).

II. To determine whether a 16-week exercise intervention will improve physical fitness in
breast cancer survivors soon after completion of cancer-related treatments by measuring
cardiorespiratory fitness and muscle strength.

III. To assesses the feasibility of a supervised exercise intervention in early breast cancer
survivors.

IV. To determine whether a 16-week exercise intervention will result in a reduction in
adipose tissue inflammation in obese breast cancer survivors soon after completion of
cancer-related treatments by measuring ATM phenotype and ATM cytokine expression.

V. To determine whether breast cancer survivors can maintain positive benefits of an exercise
intervention following a 12-week follow-up period by measuring changes in body composition,
waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive
protein, and HbA1c, cardiorespiratory fitness and muscle strength.

OUTLINE:

Patients are randomized to 1 of 2 arms.

Arm I (Control): Patients refrain from increasing physical activity levels for 16 weeks.

Arm II (Exercise): Patients participate in supervised exercise sessions over 60 minutes
thrice weekly and are encouraged to participate in a home-based exercise session over 30-45
minutes once weekly for 16 weeks.

Inclusion Criteria:

- Newly diagnosed (I-III) with a first primary invasive breast cancer

- Have undergone a lumpectomy or mastectomy

- Have completed neoadjuvant/adjuvant chemotherapy and able to initiate Exercise program
(if randomized to that arm) within 12 weeks of therapy completion

- Body mass index (BMI) > 25 kg/m^2 or body fat > 30% (determined by Dr. Dieli-Conwright
at baseline visit)

- Currently participate in less than 60 minutes of physical activity per week May use
adjuvant endocrine therapy if use will be continued for duration of study period

- Nonsmokers (i.e., not smoking during previous 12 months)

- Willing to travel to the exercise facility and USC

- Able to provide physician clearance to participate in exercise program

- Women of all racial and ethnic backgrounds will be included in the study enrollment
process

Exclusion Criteria:

- History of chronic disease including diabetes, uncontrolled hypertension or thyroid
disease

- Weight reduction >= 10% within past 6 months

- Diagnosed with human epidermal growth factor receptor 2 (HER2)-positive tumor
(exclusion due to patient use of Herceptin medication for 1 year following
chemotherapy)

- Metastatic disease

- Planned reconstructive surgery with flap repair during trial and follow-up period

- Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude
moderate physical activity