NCT00053898

Anastrozole or Tamoxifen in Treating Postmenopausal Women With Ductal Carcinoma in Situ Who Are Undergoing Lumpectomy and Radiation Therapy

A Clinical Trial Comparing Anastrozole With Tamoxifen in Postmenopausal Patients With Ductal Carcinoma in Situ (DCIS) Undergoing Lumpectomy With Radiation Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,104 (actual)
• Sponsor: NSABP Foundation Inc · Network
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	anastrozole	1 mg/day and placebo for 5 years
DRUG	tamoxifen citrate	20 mg/day and placebo for 5 years
RADIATION	Radiation Therapy	Adjuvant radiation therapy

Timeline

• Start date: 2003-01-01
• Primary completion: 2015-03-01
• Completion: 2016-05-01
• First posted: 2003-02-06
• Last updated: 2018-09-20
• Results posted: 2018-03-12

Locations

740 sites across 3 countries: United States, Canada, Puerto Rico