A Clinical Trial Comparing Anastrozole With Tamoxifen in Postmenopausal Patients With Ductal Carcinoma in Situ (DCIS) Undergoing Lumpectomy With Radiation Therapy
A Clinical Trial Comparing Anastrozole With Tamoxifen in Postmenopausal Patients With Ductal Carcinoma in Situ (DCIS) Undergoing Lumpectomy With Radiation Therapy
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Tamoxifen may fight breast cancer by blocking the use of estrogen. Anastrozole may fight breast cancer by decreasing estrogen production. It is not yet known whether anastrozole is more effective than tamoxifen in preventing the recurrence of breast cancer.
PURPOSE: This randomized phase III trial is studying anastrozole to see how well it works compared to tamoxifen in preventing the recurrence of breast cancer in postmenopausal women with ductal carcinoma in situ who are undergoing lumpectomy and radiation therapy.
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (under 60 vs 60 and over). Patients are randomized to 1 of 2 treatment arms (arm I and arm II closed to accrual as of 6/15/06).
Beginning within 8 weeks of randomization, all patients also undergo whole breast radiotherapy, unless the patient is enrolled in protocol NSABP-B-39 and randomized to the partial breast irradiation group.
Patients are followed every 6 months for 5 years, and then annually thereafter.
For patients enrolled in the quality of life study, quality of life is assessed at baseline and then every 6 months for 6 years.*
NOTE: *The quality of life study closed to accrual as of 12/28/04.
PROJECTED ACCRUAL: A total of 3,000 patients (1,500 per treatment arm) will be accrued for this study within 5 years (arm I and arm II closed to accrual as of 6/15/06).
DISEASE CHARACTERISTICS:
Histologically confirmed ductal carcinoma in situ (DCIS) of the breast
Must have undergone lumpectomy
More than 1 area of DCIS allowed provided all disease is removed with tumor-free margins
No prior invasive breast cancer or DCIS
No prior or concurrent invasive (including microinvasive) breast cancer
No bilateral malignancy
No Paget's disease of the nipple
No positive ipsilateral axillary or intramammary nodes
Hormone receptor status:
Estrogen- or progesterone-receptor positive as determined by immunohistochemistry
PATIENT CHARACTERISTICS:
Age
Sex:
Menopausal status:
Postmenopausal as defined by at least 1 of the following:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Endocrine therapy
No prior or concurrent aromatase inhibitors (e.g., exemestane or letrozole) or tamoxifen
No concurrent raloxifene or other selective estrogen receptor modulators
No concurrent sex hormone therapy (e.g., estrogen or progesterone replacement therapy, oral contraceptives, androgens, luteinizing hormone releasing hormone analogs, prolactin inhibitors, or antiandrogens)
Radiotherapy
Surgery
Other
No concurrent warfarin
No other systemic therapy for this cancer initiated before study
No other concurrent anticancer therapy unless permitted by the protocol investigator
No concurrent participation in another clinical trial of therapy for DCIS
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