CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 13 enrolled
Drug / intervention
therapeutic estradiol +3 morebiological
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/NCT01385280
NCT01385280N/ACompleted

A Pilot Study Of Estradiol Followed By Exemestane For Post-Menopausal Hormone Receptor Positive Metastatic Breast Cancer After Prior Failed Endocrine Therapy: Reversing Endocrine Resistance

University of Arizona·interventional·Posted Jun 30, 2011·Updated Oct 17, 2018

In Brief

A clinical study evaluating therapeutic estradiol, exemestane, and 2 other interventions for Estrogen Receptor-positive Breast Cancer and 4 related conditions. Completed, enrolled 13 participants across 1 site.

Detailed Summary

RATIONALE: Estrogen can cause the growth of tumor cells. Hormone therapy using therapeutic estradiol may fight breast cancer by lowering the amount of estrogen the body makes. Though estradiol initially produces stimulation of ER+ cancer cells, both laboratory and some clinical experience indicate that it may have the opposite effect on such cells, once they have become resistant to estrogen deprivation. In laboratory models, there is death of the "resistant" population after estradiol treatment, followed by restoration of sensitivity of the remaining cells to estrogen deprivation, as with an aromatase inhibitor. Exemestane may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving therapeutic estradiol together with exemestane may kill more tumor cells. PURPOSE: This clinical trial studies therapeutic estradiol and exemestane in treating post-menopausal patients with hormone receptor-positive metastatic breast cancer

Study Details

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 30, 2011
Enrollment StartFeb 1, 2011
Primary CompletionJan 1, 2013
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.0 years ago

Interventions

therapeutic estradiolbiological

Given orally (PO)

exemestanedrug

Given PO

laboratory biomarker analysisother

Correlative studies

enzyme-linked immunosorbent assayother

Correlative studies