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Randomized Anastrozole Exercise Trial (The RAE Study)

Phase 3
18 Years
Open (Enrolling)
Musculoskeletal Symptoms

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Trial Information

Randomized Anastrozole Exercise Trial (The RAE Study)

Inclusion Criteria:

- Women who have been on an adjuvant AI for at least 6 weeks.

- The presence of some musculoskeletal symptoms.

- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1

- ER and or PgR positive early breast cancer, stages I, II or III

- Completion of any adjuvant chemotherapy (if given) and primary breast cancer surgery.

- Be willing to switch to Anastrozole if on another AI

- Signed written informed consent

Exclusion Criteria:

- Metastatic disease (no imaging or labs required in absence of clinical suspicion of

- Evidence or history of inflammatory arthropathy (for example, rheumatoid arthritis)

- Any medical condition (for example, significant heart disease) that would prevent a
subject from completing an exercise program.

- Unable to take Aromatase Inhibitor (AI)

- Planned secondary reconstruction procedures during the 48 week study period

- Any medical, physical, geographic, emotional, or economic condition that in the
judgement of the clinician/study doctor, would make an individual unable or unlikely
to be able to exercise three times a week for 12 weeks.

- Unable to complete a study log book and questionnaires (unable to read and write
English and no one at home who can adequately do so).

- The use of any exogeneous estrogen and/or progesterone except Estring and natural
plant estrogens

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary endpoint is the mean SF36 physical component summary (PCS) score for subjects in each study Arm after 12 weeks.

Principal Investigator

Hagen Kennecke, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

BC Cancer Agency Vancouver Centre


Canada: Ethics Review Committee

Study ID:

RAE Study



Start Date:

December 2007

Completion Date:

Related Keywords:

  • Musculoskeletal Symptoms
  • Anastrozole
  • Exercise