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: * Compare the value of anastrozole vs tamoxifen, in terms of preventing recurrence (i.e., local, regional, and distant recurrences and contralateral breast cancer), after lumpectomy and radiotherapy in postmenopausal women with ductal carcinoma in situ (DCIS). * Compare subsequent disease occurrence, in terms of invasive breast cancer (local, regional, distant, or contralateral), ipsilateral and contralateral breast cancer (invasive and DCIS), and non-breast second primary malignancies, in patients treated with these drugs. * Compare quality of life and symptoms of patients treated with these drugs.\* * Compare quality-adjusted survival time of patients treated with these drugs.\* * Compare the occurrence of osteoporotic fractures in patients treated with these drugs. * Compare disease-free and overall survival of patients treated with these drugs. NOTE: \*The quality of life study closed to accrual as of 12/28/04. 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). * Arm I (closed to accrual as of 6/15/06): Patients receive oral tamoxifen and oral placebo once daily for 5 years. * Arm II (closed to accrual as of 6/15/06): Patients receive oral anastrozole and oral placebo once daily for 5 years. 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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
3,104
1 mg/day and placebo for 5 years
20 mg/day and placebo for 5 years
Adjuvant radiation therapy
Northeast Alabama Regional Medical Center
Anniston, Alabama, United States
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States
Huntsville Hospital
Huntsville, Alabama, United States
Mobile Infirmary Medical Center
Mobile, Alabama, United States
East Alabama Medical Center
Opelika, Alabama, United States
Percentage of Patients Free From Breast Cancer
Percentage of patients free from breast cancer event at 10 years where events include local, regional, or distant recurrence or contralateral breast cancer, invasive or DCIS.
Time frame: 10 years
Percentage of Patients Free From Invasive Breast Cancer
Percentage of patients free from an invasive breast cancer event where events include invasive local, regional, or distant recurrence, or contralateral breast cancer, occurring as a first cancer event. Note that this endpoint includes only invasive breast cancers and the primary endpoint includes both invasive and DCIS breast cancers.
Time frame: 10 years
Percentage of Patients Free From Ipsilateral Recurrence
Percentage of patients free from a breast cancer recurrence in the ipsilateral breast (invasive and DCIS), occurring as a first cancer event.
Time frame: 10 years
Percentage of Patients Free From Contralateral Breast Cancer
Percentage of patients free from a breast cancer recurrence in the contralateral breast (invasive and DCIS), occurring as a first cancer event.
Time frame: 10 years
Percentage of Patients Free From Non-breast Secondary Cancer
Percentage of patients free from any non-breast second primary cancer other than squamous or basal cell carcinoma of the skin, carcinoma in situ of the colon, melanoma in situ, or carcinoma in situ of the cervix, occurring as a first cancer event.
Time frame: 10 years
Percentage of Patients Free From Osteoporotic Fractures
Percentage of patients free from fractures of the hip, spine, and wrist.
Time frame: 10 years
Percentage of Patients Alive and Disease-free
Percentage of patients free from a disease-free survival event where events include any recurrence, second primary cancer, and death from any cause. Lobular carcinoma in situ (LCIS), basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the colon, melanoma in situ, and cervical carcinoma in situ will not be included as recurrences or second primary cancer.
Time frame: 10 years
Percentage of Patients Alive (Overall Survival)
Percentage of patients alive.
Time frame: 10 years
Quality of Life-Short Form 12 (SF-12) Physical Health Component Score
The primary outcome of the QOL substudy was the Medical Outcomes Study-Short Form 12 (SF-12) physical health component scale score. The SF-12 physical score was calculated to have a range of 0-100 and was normalized to have a mean of 50 and a standard deviation of 10 in the general population. Higher scores indicate better health.
Time frame: 5 years
Quality-adjusted Survival Time
The mean quality-adjusted survival time (in months) in each treatment group, estimated by the Quality-Adjusted Time without Symptoms and Toxicity (Q-TWIST) method.
Time frame: 10 years
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