Neoadjuvant and Adjuvant Exemestane in Treating Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Study of Neoadjuvant and Adjuvant Exemestane in Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer

Conditions
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Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

Intervention / Treatment
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* Drug: exemestane
* Procedure: adjuvant therapy
* Procedure: aromatase inhibition
* Procedure: conventional surgery
* Procedure: endocrine therapy
* Procedure: hormone therapy
* Procedure: neoadjuvant therapy
* Procedure: surgery


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: exemestane|nan|
|Procedure: adjuvant therapy|nan|
|Procedure: aromatase inhibition|nan|
|Procedure: conventional surgery|nan|
|Procedure: endocrine therapy|nan|
|Procedure: hormone therapy|nan|
|Procedure: neoadjuvant therapy|nan|
|Procedure: surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |