CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 159 enrolled
Drug / intervention
Everolimus +2 moredrug
Likely dose
Everolimus 5 mgfrom 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/NCT03312738
NCT03312738Phase 2Completed
CompareCT.gov

A Randomized, Double-blind, Placebo Controlled, Phase II Study of Everolimus in Combination With Exemestane in the Treatment of Chinese Postmenopausal Women With Estrogen Receptor Positive, HER-2 Negative, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Prior Letrozole or Anastrozole

Novartis Pharmaceuticals·interventional·Posted Oct 18, 2017·Updated Jan 23, 2024

In Brief

A Phase 2 clinical trial evaluating Everolimus, Exemestane, and 1 other intervention for Advanced Breast Cancer. Completed, enrolled 159 participants across 15 sites.

Detailed Summary

This study aimed at evaluating the safety and efficacy of everolimus plus exemestane in Chinese postmenopausal women with ER+ HER2- locally advanced, recurrent, or metastatic breast cancer after recurrence or progression on letrozole or anastrozole.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Breast Cancer
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedOct 18, 2017
Enrollment StartSep 15, 2017
Primary CompletionApr 25, 2022
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 8.7 years ago

Interventions

Everolimusdrug

Everolimus was formulated as tablets of 5 mg strength and was packaged into blister packs . Everolimus (two 5 mg tablets daily) was administered in a blinded manner by continuous oral daily dosing.

Exemestanedrug

Commercially available exemestane was supplied as 25 mg tablets. Exemestane was administered as continuous oral daily dose of 25 mg tablets.

Everolimus Placebodrug

Placebo was formulated to be indistinguishable from the everolimus tablets. Matching placebo (two tablets daily) was administered in a blinded manner by continuous oral daily dosing.