CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 622 enrolled
Drug / intervention
anastrozole +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00265759
NCT00265759Phase 3Completed

A Randomized Phase III Trial Comparing 16 to 18 Weeks of Neoadjuvant Exemestane (25 mg Daily), Letrozole (2.5 mg), or Anastrozole (1 mg) in Postmenopausal Women With Clinical Stage II and III Estrogen Receptor Positive Breast Cancer

Alliance for Clinical Trials in Oncology·interventional·Posted Dec 15, 2005·Updated Apr 23, 2025

In Brief

A Phase 3 clinical trial evaluating anastrozole, exemestane, and 2 other interventions for Breast Cancer. Completed, enrolled 622 participants across 3 sites.

Detailed Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane, letrozole, or anastrozole, may fight breast cancer by lowering the amount of estrogen the body makes. Giving exemestane, letrozole, or anastrozole before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether exemestane, letrozole, or anastrozole is more effective in treating breast cancer. PURPOSE: This randomized phase III trial is studying exemestane, letrozole, and anastrozole to compare how well they work in treating postmenopausal women who are undergoing surgery for stage II or stage III breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 15, 2005
Enrollment StartJan 1, 2006
Primary CompletionAug 1, 2012
Study CompletionNov 27, 2019
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 20.5 years ago

Interventions

anastrozoledrug

Given PO

exemestanedrug

Given PO

letrozoledrug

Given PO

Therapeutic Conventional Surgeryprocedure

Undergo partial or radical mastectomy or lumpectomy with or without lymph node dissection