CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 7,576 enrolled
Drug / intervention
anastrozole +1 moredrug
Likely dose
Anastrozole or exemestane, given orally (specific doses not specified in published record)AI-extracted
Key inclusion· 8
  • Histologically confirmed invasive breast cancer, pT1-3; pNX, pN0-2 or pN3 (only when 10+ involved axillary lymph nodes); M0
  • Completely resected primary tumor, last surgery 3 weeks to 3 months before entry (if no chemotherapy) or 3 weeks to 3 months after chemotherapy
  • Estrogen receptor- and/or progesterone receptor-positive by immunohistochemistry or tumor receptor content ≥10 fmol/mg protein
  • Postmenopausal status: >60 years, OR age 45-59 with ≥1 year spontaneous menstrual cessation, OR age 45-59 with FSH in postmenopausal range, OR bilateral oophorectomy
Key exclusion· 7
  • Metastases confirmed by imaging (bone scan, abdominal ultrasound/CT, or chest x-ray as indicated)
  • Locally recurrent disease
  • Prior or concurrent carcinoma in situ of contralateral breast treated with partial mastectomy and/or hormonal therapy
  • Metachronous breast cancer

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

Search/NCT00066573
NCT00066573Phase 3Completed

A Randomized Phase III Trial Of Exemestane Versus Anastrozole In Postmenopausal Women With Receptor Positive Primary Breast Cancer

NCIC Clinical Trials Group·interventional·Posted Aug 7, 2003·Updated Aug 25, 2023

In Brief

A Phase 3 clinical trial evaluating anastrozole and exemestane for Breast Cancer. Completed, enrolled 7,576 participants across 39 sites.

Detailed Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy, using exemestane or anastrozole, may fight breast cancer by reducing the production of estrogen. It is not yet known whether exemestane is more effective than anastrozole in preventing the recurrence of breast cancer. PURPOSE: This randomized phase III trial is studying exemestane to see how well it works compared to anastrozole in preventing cancer recurrence in postmenopausal women who have undergone surgery for primary breast cancer.

Study Details

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 7, 2003
Enrollment StartJun 6, 2003
Primary CompletionNov 7, 2010
Study CompletionJan 6, 2012
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 22.9 years ago

Interventions

anastrozoledrug

Given orally

exemestanedrug

Given orally