Neoadjuvant and Adjuvant Exemestane in Treating Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer
Neoadjuvant and Adjuvant Exemestane in Treating Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer
RATIONALE: Estrogen and progesterone can stimulate the growth of breast cancer cells. Hormone
 therapy using exemestane may fight breast cancer by reducing the production of estrogen and
 progesterone. Giving hormone therapy before surgery may shrink the tumor so it can be removed
 with breast-conserving surgery. Giving hormone therapy after surgery may kill any remaining
 tumor cells.

 PURPOSE: Phase II trial to study the effectiveness of neoadjuvant and adjuvant exemestane in
 treating postmenopausal women who have locally advancedestrogen and/or progesterone
 receptor-positive breast cancer.
OBJECTIVES:

 Primary

 -  Determine the clinical response rate in postmenopausal women with locally advanced
 hormone receptor-positive breast cancer treated with neoadjuvant and adjuvant
 exemestane.

 Secondary

 -  Determine the response rate by mammography, ultrasound, MRI, and positron emission
 tomography scan in patients treated with this drug.

 -  Determine the time to progression in patients treated with this drug.

 -  Compare the expression of hormone receptors and epidermal growth factor receptors
 (including HER2/neu) in patients prior to and after treatment with this drug and
 correlate these results with clinical response rates.

 OUTLINE: Patients receive oral exemestane once daily for 16 weeks in the absence of disease
 progression or unacceptable toxicity. After 16 weeks, patients undergo surgery and then
 continue exemestane once daily for a total of 5 years (including the 16 weeks before
 surgery).

 Patients are followed every 3 months for 2 years after surgery and then every 6 months
 thereafter.

 PROJECTED ACCRUAL: A total of 16-46 patients will be accrued for this study within 2 years.
DISEASE CHARACTERISTICS:

 -  Histologically or cytologically confirmed breast cancer

 -  Locally advanced disease (stage II or III)

 -  Not amenable to breast-conserving therapy at the time of diagnosis

 -  Measurable disease meeting 1 of the following criteria:

 -  Bidimensionally measurable palpable lesion at least 1 cm by caliper

 -  Unidimensionally measurable lesion at least 1 cm by a positive mammogram, ultrasound,
 or MRI

 -  No evidence of disease outside the breast or chest wall except ipsilateral axillary
 lymph nodes

 -  Hormone receptor status:

 -  Estrogen and/or progesterone receptor positive

 PATIENT CHARACTERISTICS:

 Age

 -  Postmenopausal

 Sex

 -  Female

 Menopausal status

 -  Postmenopausal, defined as any of the following:

 -  Over 60 years of age

 -  Over 45 years of age with an intact uterus and amenorrhea for more than 12 months

 -  Prior hysterectomy with follicle-stimulating hormone levels within the postmenopausal
 range

 -  Prior ovarian ablation (i.e., bilateral surgical)

 Performance status

 -  ECOG 0-3

 Life expectancy

 -  Not specified

 Hematopoietic

 -  Not specified

 Hepatic

 -  Bilirubin less than 1.5 times upper limit of normal (ULN)

 Renal

 -  Creatinine less than 2 mg/dL

 Other

 -  No other prior or concurrent cancer except nonmetastatic nonmelanoma skin cancer,
 carcinoma in situ of the cervix, or cancer cured by surgery within the past 5 years

 PRIOR CONCURRENT THERAPY:

 Biologic therapy

 -  No prior biologic therapy for breast cancer

 Chemotherapy

 -  No prior chemotherapy for breast cancer

 Endocrine therapy

 -  No prior hormonal therapy for breast cancer

 Radiotherapy

 -  No prior radiotherapy for breast cancer

 Surgery

 -  Not specified