Trial Information

Summary: ACOSOG Z1031: A Randomized Phase III Trial Comparing 16 to 18 Weeks of Neoadjuvant Drugs in Postmenopausal Women with Clinical Stage II/III Breast Cancer

ACOSOG Z1031: A Randomized Phase III Trial Comparing 16 to 18 Weeks of Neoadjuvant Exemestane (25mg daily), Letrozole (2.5mg), or Anastrozole (1mg)in Postmenopausal Women with Clinical Stage II and III Estrogen Receptor Positive Breast Cancer

Patients eligible to participate in the study will be randomized to use one of three drugs. The patient will be evaluated every four weeks to assess how the cancer is progressing and the patient's compliance in receiving/taking the drug assigned. All patients must have a resection done of the primary tumor. The drug will be administered 16-18 weeks before surgery is performed.

Inclusion Criteria: Patients must meet ALL of the following:

• Must have an ECOG/Zubrod performance status of = 2
• Must have T2-T4c, any N, M0 breast cancer, by clinical staging. Primary tumor MUST BE palpable and measure 2cm by caliper measurements in at least one dimension.
• Must be postmenopausal verified by bilateral surgical oophorectomy or no spontaneous menses = 1 year or no menses for < 1 year with FSH & estradiol levels in postmenopausal range according to institutional standards
• As documented by operating surgeon, patient is clinically staged as one of the following: T4 a-c for whom modified radical mastectomy with negative margins is the goal; T2 or T3 for whom conversion from needing mastectomy to breast conservation is the goal; or T2 for whom lumpectomy at first attempt is the goal
• Has an ER+ tumor with an Allred score of 6, 7, or 8
• Must have mammogram & ultrasound within 42 days prior to registration
• Patient or legally authorized representative must sign a study-specific informed consent document. This must be obtained PRIOR to first study related procedure
• Patient must provide written authorization allowing the use and disclosure of protected health information. This may be obtained in either study specific informed consent or in separate authorization form AND must be obtained from patient PRIOR to study pre-registration
• If patient is a cancer survivor, all of the following MUST BE met: has undergone potentially curative therapy for all prior malignancies, no evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, or non-melanoma skin cancer without evidence of recurrence. Patient must be deemed by the treating physician to be at low risk for recurrence from prior malignancy

Exclusion Criteria: Patient WILL NOT be eligible if any of the following apply:

• Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema)
• Prior treatment for breast cancer including radiation, endocrine therapy, chemotherapy, or investigational agent
• Has received hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration
• Has distal metastasis (M1), excluding isolated ipsilateral supraclavicular node involvement
• Patient does not agree to undergo mastectomy or lumpectomy after neoadjuvant aromatase inhibitor therapy
• Patient is enrolled in another neoadjuvant clinical trial for treatment of the existing breast cancer

If you would like to learn more about participating in this study, please send an e-mail message using the form below.