CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
Everolimus +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/NCT02291913
NCT02291913Phase 2Completed
CompareCT.gov

Phase II Open Label Study of Everolimus in Combination With Anti-estrogen Therapy in Hormone Receptor-Positive HER2-Negative Advanced Breast Cancer

SCRI Development Innovations, LLC·interventional·Posted Nov 17, 2014·Updated Feb 17, 2020

In Brief

A Phase 2 clinical trial evaluating Everolimus, Exemestane, and 5 other interventions for Breast Cancer. Completed, enrolled 48 participants across 8 sites.

Detailed Summary

Many patients with ER-positive or PR-positive breast cancer are treated with endocrine therapy. Although most ER/PR-positive tumors initially respond to hormonal therapy, patients often experience disease progression. Everolimus, in combination with exemestane, has shown activity in endocrine-resistant disease. This study will evaluate the efficacy of Everolimus+ anti-estrogen therapy in patients with ER-positive metastatic breast cancer who have progressed after receiving anti-estrogen therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsNovartis

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 17, 2014
Enrollment StartDec 18, 2014
Primary CompletionJan 31, 2019
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 11.6 years ago

Interventions

Everolimusdrug

Exemestanedrug

Anti-estrogen therapy

Tamoxifendrug

Anti-estrogen therapy

Fulvestrantdrug

Anti-estrogen therapy

Anastrozoledrug

Anti-estrogen therapy

Letrozoledrug

Anti-estrogen therapy

Toremifinedrug

Anti-estrogen therapy