CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,560 enrolled
Drug / intervention
exemestanedrug
Likely dose
Exemestane 25 mg orally once dailyAI-extracted
Key inclusion· 3
  • ✓Postmenopausal women age 35 and over
  • ✓At increased risk of developing breast cancer with at least one of: Gail score ≥1.66, age ≥60, prior atypical ductal/lobular hyperplasia, or prior DCIS treated with total mastectomy
  • ✓Postmenopausal status confirmed by age >50 with ≥12 months amenorrhea, or age ≤50 with ≥12 months amenorrhea and FSH in postmenopausal range, or prior bilateral oophorectomy
Key exclusion· 6
  • ✕Prior DCIS treated with lumpectomy with or without radiation
  • ✕Prior invasive breast cancer
  • ✕BRCA1 or BRCA2 carriers
  • ✕Other malignancies within past 5 years except nonmelanoma skin cancer or curatively treated cervical carcinoma in situ

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

Search/NCT00083174
NCT00083174Phase 3Completed
CompareCT.gov

A Phase III Randomized Study of Exemestane Versus Placebo in Postmenopausal Women at Increased Risk of Developing Breast Cancer

NCIC Clinical Trials Group·interventional·Posted May 17, 2004·Updated Aug 25, 2023

In Brief

A Phase 3 clinical trial evaluating exemestane for Breast Cancer. Completed, enrolled 4,560 participants across 76 sites in 4 countries.

Detailed Summary

RATIONALE: The MAP.3 study was designed to test whether hormone therapy using exemestane may prevent breast cancer by blocking the production of estrogen. PURPOSE: The study protocol was amended in May 2011 and the current purpose of the study is to allow all study participants the opportunity to complete 5 years of exemestane.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesCanada, France, Puerto Rico, United States
CollaboratorsGrupo Espanol de Investigacion del Cancer de Mama, UNICANCER

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 17, 2004
Enrollment StartDec 3, 2004
Primary CompletionMar 25, 2011
Study CompletionJan 22, 2018
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 22.1 years ago

Interventions

exemestanedrug

one 25 mg tablet daily in am