Exercise Intervention in Preventing Breast Cancer Recurrence in Postmenopausal Breast Cancer Survivors

PRIMARY OBJECTIVES:

I. To test the hypothesis that regular exercise increases DNA repair capacity.

II. To test the hypothesis that regular exercise reduces inflammatory response.

III. To test the hypothesis that regular exercise modulates telomerase activity.

SECONDARY OBJECTIVES:

I. To assess adherence to the study protocol.

II. To examine differences in body composition before and after the exercise intervention.

III. To examine differences in fitness before and after the exercise intervention.

IV. To test the hypothesis that regular exercise increases quality of life in breast cancer
survivors.

V. To examine the safety of the exercise intervention.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients participate in a supervised Curves exercise program three days a week for 16
weeks. The circuit-style workout consists of 14 exercises constructed with pneumatic or
hydraulic resistance that target opposing muscle groups in a concentric-only fashion. Each
session at a Curves facility will include two complete circuits which correspond to
exercising for approximately 30 minutes followed by a standardized stretching routine.

ARM II: Patients do not participate in a formal exercise program for 16 weeks. Patients are
then offered the Curves exercise intervention.

Inclusion Criteria:

- The study will be conducted in women who have been diagnosed with a first primary
invasive estrogen receptor (ER) positive (+) breast cancer (stages I-IIIa) who are
within the first 3 years post-treatment

- The study will be conducted in postmenopausal women

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control or abstinence) prior to study entry and
for six months following duration of study participation; should a woman become
pregnant or suspect that she is pregnant while participating on the trial, she should
inform her treating physician immediately

- Postmenopausal, defined as meeting any of the following criteria:

- Periods stopped more than 6 months ago

- Bilateral oophorectomy

- Not already classified as pre- or peri-menopausal

- Started using hormone therapy for menopausal symptoms before periods stopped,
and/or

- Hysterectomy before age 56 years but aged 56 years or more at baseline

- Any body mass index (BMI)

- Sedentary (have not participated in a regular exercise program in the past 12 months)

- Nonsmokers (not smoking during previous 12 months)

- Willing and able to travel to the exercise facility

- Diagnosed with a first primary invasive ER+ breast cancer (stages I-IIIa)

- Have undergone a lumpectomy or mastectomy

- Have completed adjuvant chemotherapy and/or radiation within the past 3 years prior to
study enrollment (when cytokine levels are predicted to be high) and able to initiate
an exercise program

- May use adjuvant endocrine therapy if use will be continued for duration of study
period

- All subjects must have the ability to understand and the willingness to sign a written
informed consent

Exclusion Criteria:

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

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

- Regular, necessary use of nonsteroidal anti-inflammatory drugs (NSAIDs) (will be asked
to stop use during study period)

- Currently taking postmenopausal hormone replacement therapy

- Stage IV or distant metastatic disease

- Planned reconstructive surgery with flap repair during study period

- Subjects, who in the opinion of the investigator, may not be able to comply with the
safety monitoring requirements of the study