CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 180 enrolled
Drug / intervention
Exemestane +6 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/NCT02598557
NCT02598557Phase 2Completed

Alternative Dosing of Exemestane in Postmenopausal Women With Stage 0-II ER-Positive Breast Cancer: A Randomized Presurgical Trial

National Cancer Institute (NCI)·interventional·Posted Nov 6, 2015·Updated Aug 22, 2023

In Brief

A Phase 2 clinical trial evaluating Exemestane, Laboratory Biomarker Analysis, and 5 other interventions for Stage 0 Breast Cancer AJCC v6 and v7 and 6 related conditions. Completed, enrolled 180 participants across 5 sites in 2 countries.

Detailed Summary

This phase IIb trial studies how well alternative dosing of exemestane before surgery works in treating in postmenopausal patients with stage 0-II estrogen positive breast cancer. Chemoprevention is the use of drugs to keep breast cancer from forming or coming back. The use of exemestane may treat early stage (stage 0-II) breast cancer. Comparing the exemestane standard dose regimen versus two alternative, less frequent dose regimens may decrease undesirable symptoms and have similar efficacy in reducing serum estradiol.

Study Details

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 6, 2015
Enrollment StartDec 6, 2016
Primary CompletionOct 3, 2019
Study CompletionFeb 2, 2023
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.7 years ago

Interventions

Exemestanedrug

Given PO

Laboratory Biomarker Analysisother

Correlative studies

Pharmacological Studyother

Correlative studies

Placebo Administrationother

Given PO

Quality-of-Life Assessmentother

Ancillary studies

Questionnaire Administrationother

Ancillary studies

Therapeutic Conventional Surgeryprocedure

Undergo surgery