A Randomized Trial Evaluating The Effect Of Exemestane In Clinical Stage T1-3 N0-1 M0 Postmenopausal Breast Cancer Patients Completing At Least Five Years Of Tamoxifen Therapy
A Randomized Trial Evaluating The Effect Of Exemestane In Clinical Stage T1-3 N0-1 M0 Postmenopausal Breast Cancer Patients Completing At Least Five Years Of Tamoxifen Therapy
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen by the tumor cells. It is not yet known whether exemestane is effective in preventing the recurrence of breast cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of exemestane in preventing cancer recurrence in postmenopausal women who have resected stage I, stage II, or stage IIIA breast cancer and have completed 5 years of tamoxifen.
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline and then every 6 months for 5.5 years.
Patients are followed every 6 months for 6 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 3,000 patients will be accrued for this study within 3 years and 4 months.
DISEASE CHARACTERISTICS:
Histologically confirmed invasive adenocarcinoma of the breast at time of original diagnosis
Prior surgical resection, including 1 of the following:
Total mastectomy and axillary dissection (modified radical mastectomy) OR
Lumpectomy and axillary dissection
Prior sentinel node biopsy allowed with the exception of the following:
Previously resected margins must be clear of invasive tumor and ductal carcinoma in situ
Currently disease free
Previously treated with tamoxifen for 57-66 months
No bilateral malignancy or mass in the opposite breast suspicious for malignancy unless biopsy proven negative
No local, regional, or distant recurrence of disease or second primary breast malignancy (including contralateral breast cancer)
No advanced disease at time of original diagnosis (e.g., ulceration, erythema, infiltration of the skin or underlying chest wall [complete fixation], peau d'orange, or skin edema of any magnitude)
Current skeletal pain allowed if a bone scan and/or radiologic exam is negative for metastatic disease
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Postmenopausal, defined as 1 of the following:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
See Disease Characteristics
No concurrent estrogen, progesterone, clomiphene, testosterone, gonadotropin-releasing hormone, oral contraceptives, selective estrogen-receptor modulators, or dehydroepiandrosterone (DHEA)
No other concurrent systemic hormonal therapy (e.g., tamoxifen or raloxifene)
Radiotherapy:
Surgery:
Other:
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