At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed DCIS of the breast, including mixed DCIS and LCIS
- ✓Completed lumpectomy with histologically tumor-free margins, within 84 days before enrollment
- ✓Estrogen- or progesterone-receptor positive by immunohistochemistry (borderline results considered positive)
- ✓Postmenopausal status (defined by prior bilateral oophorectomy, ≥12 months without menses, age ≥55 with prior hysterectomy, or age ≤54 with hysterectomy and postmenopausal FSH)
- ✕Prior or concurrent invasive breast cancer, microinvasive breast cancer, or prior DCIS
- ✕Bilateral breast malignancy or suspicious abnormality in opposite breast unless proven benign by biopsy
- ✕Paget's disease of the nipple
- ✕Positive ipsilateral axillary or intramammary nodes
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Clinical Trial Comparing Anastrozole With Tamoxifen in Postmenopausal Patients With Ductal Carcinoma in Situ (DCIS) Undergoing Lumpectomy With Radiation Therapy
In Brief
A Phase 3 clinical trial evaluating anastrozole, tamoxifen citrate, and 1 other intervention for Breast Cancer. Completed, enrolled 3,104 participants across 740 sites in 3 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
1 mg/day and placebo for 5 years
20 mg/day and placebo for 5 years
Adjuvant radiation therapy