IRB Number:

06-006995

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

Patients are being asked to take part in this study because they have a kind of breast cancer that is affected by the levels of hormones in their body. Patients are also postmenopausal, which can affect the way this kind of cancer responds to certain kinds of treatment. The surgical options do not include the kind of surgery known as breast conserving treatment (or lumpectomy), or in some cases, mastectomy, at this time.

Breast conserving treatment (lumpectomy) is a type of surgery in which the cancer, plus a small amount of surrounding normal tissue, is removed. Mastectomy is a surgical procedure in which the entire breast is removed. Researchers have been studying breast cancer to learn the best way to treat the disease. Chemotherapy (treatment with anticancer drugs) is commonly given before surgery to shrink breast tumors. The therapy in this research study consists of one of three drugs of a type called hormone therapy (a drug used to lower the level of the hormone estrogen). The hormone therapies being tested in this study are exemestane, anastrozole, and letrozole. Research has shown that reducing the amount of the hormone estrogen that gets to the cancer in postmenopausal women with hormone-dependent breast cancer can shrink the breast tumor before surgery.

This study is being done to find out whether it is better to receive exemestane, anastrozole, or letrozole to improve the chance that the breast cancer will get smaller before surgery.

Who is Eligible to Participate in the Study?

-Diagnosed with Stage 2 or 3 breast cancer
-Postmenopausal
-Estrogen receptor positive (ER+)

More specific, detailed eligibility and/ or exclusion criteria are associated with this trial.

What is Involved With this Study?

If patients are taking raloxifene (brand name Evista, a drug used to strengthen bones and which the FDA has approved for treating a disease called osteoporosis in postmenopausal women) or hormone replacement therapy (HRT) of any kind, including megestrol acetate (brand name Megace - a type of hormonal therapy mainly used in treatment of breast cancer), they will need to stop taking it for at least seven days before being able to take part in the study. In addition, patients will not be able to take raloxifene or HRT while they are taking the study drugs.

If a patient agrees to participate, and if they meet all of the study requirements, patients will be randomized to receive exemestane, anastrozole, or letrozole. Being randomized means that a patient is put into a group by chance (as in the flip of a coin). A computerized selection process will be used to assign participants to the study groups. Neither the patient nor the researcher will choose what group the patient will be in. By the time enrollment to the study is finished, there will be approximately equal number of people receiving exemestane, anastrozole, or letrozole.

Patients will receive:
Group 1: Exemestane
If randomized to Group 1: for 16 to 18 weeks patients will take 1 tablet (25 milligrams [mg]) of exemestane once per day with the last tablet taken the day before surgery.
OR
Group 2: Letrozole
If randomized to Group 2: for 16 to 18 weeks, patients will take 1 capsule (1 mg) of letrozole once per day with the last tablet taken the day before surgery.
OR
Group 3: Anastrozole
If randomized to Group 3: for 16 to 18 weeks, patients will take 1 capsule (2.5 mg) of anastrozole once per day with the last tablet taken the day before surgery.

Before Starting Medication
-Breast tumor measurement will be taken with tape measure, ruler, or caliper (a mechanical measuring device)
-Mammogram and breast ultrasound
-Obtain tumor sample and place clip in breast to mark tumor site
-Blood samples collected

Week 1
-Start medication (exemestane, letrozole, or anastrozole once a day) on Day 1

Week 4
-Breast tumor measurement with tape measure, ruler, or caliper
-Continue medication

Week 8
-Breast tumor measurement with tape measure, ruler, or caliper
-Continue medication

Week 12
-Breast tumor measurement with tape measure, ruler, or caliper
-Continue medication

Week 15 (approx)
-Mammogram and breast ultrasound

Week 16
-Breast tumor measurement with tape measure, ruler, or caliper
-Finish medication
-Surgery

16-18 weeks after starting medication.
-Final dose of medication should be taken the day before surgery
-Tumor and blood samples obtained
-Post-surgery check-up (30 days after last dose of medication)

Follow-Up
-Check-up once a year for the first two years, then once every two years for eight years

How long will the Study run?

Patients will be in the study for ten years.

Sponsor(s): American College of Surgeons Oncology Group (ACOSOG)

Study Activation/Registration Date: 04/16/2007

IRB Review and Approval Date: 02/08/2007

Study Type: Treatment

Projected Accrual: The plan is to have up to 375 patients participate from multiple medical centers.

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Amy C. Degnim, MD

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 05/08/2008