CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 49 enrolled
Drug / intervention
Letrozole +1 moredrug
Likely dose
Letrozole (specific dose not stated in interventions or arms)AI-extracted
Key inclusion· 8
  • ✓Estradiol level ≥9 pg/mL
  • ✓Age ≥35 years
  • ✓Postmenopausal status (≥12 months without menses, prior hysterectomy/bilateral salpingo-oophorectomy, or ≥55 with hysterectomy, or <55 with hysterectomy and FSH postmenopausal)
  • ✓Bilateral breast examination within 6 months, bilateral mammogram within 3 months before or 30 days after randomization, normal pelvic exam within 5 years, general physical exam within 6 months
Key exclusion· 9
  • ✕Evidence of suspicious or malignant disease on clinical breast exam, mammography, pelvic exam, or general physical exam
  • ✕Prior bilateral mastectomy
  • ✕Other malignancy within past 5 years (except basal/squamous cell skin cancer or cervical carcinoma in situ)
  • ✕Osteoporosis

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

Search/NCT00090857
NCT00090857Phase 2Completed
CompareCT.gov

A Pilot Study of Aromatase Inhibitors for Women at Increased Risk of Breast Cancer Based on Estradiol Levels

Dana-Farber Cancer Institute·interventional·Posted Sep 8, 2004·Updated Mar 30, 2018

In Brief

A Phase 2 clinical trial evaluating Letrozole and Placebo for Breast Cancer. Completed, enrolled 49 participants across 5 sites.

Detailed Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Letrozole may be effective in preventing the development or recurrence of breast cancer in postmenopausal women who are at increased risk of developing breast cancer because of elevated estradiol levels. PURPOSE: This randomized phase II trial is studying how well letrozole works in preventing breast cancer in postmenopausal women with elevated estradiol levels.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), Jonsson Comprehensive Cancer Center

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 8, 2004
Enrollment StartFeb 1, 2002
Primary CompletionAug 1, 2008
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 21.8 years ago

Interventions

Letrozoledrug

Placeboother