At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 719 enrolled
Drug / intervention
Everolimus +3 moredrug
Likely dose
Everolimus 10 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.
A Randomized Phase III, Double-Blind, Placebo-Controlled Multicenter Trial of Everolimus in Combination With Trastuzumab and Paclitaxel, as First Line Therapy in Women With HER2 Positive Locally Advanced or Metastatic Breast Cancer
In Brief
A Phase 3 clinical trial evaluating Everolimus, Placebo, and 2 other interventions for Breast Cancer. Completed, enrolled 719 participants across 140 sites in 28 countries.
Detailed Summary
The purpose of this Phase III study was to confirm the value of adding everolimus to weekly paclitaxel and trastuzumab as treatment of HER2-overexpressing metastatic breast cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesArgentina, Australia, Belgium, Brazil, Canada, China, Colombia, Egypt, France, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Lebanon, Mexico, Peru, Puerto Rico, Russia, South Africa, South Korea, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States, Venezuela
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2009
Enrollment StartSep 2009
Primary CompletionMay 2014
Study CompletionOct 2017
TodayJul 2026
First PostedApr 6, 2009
Enrollment StartSep 10, 2009
Primary CompletionMay 30, 2014
Study CompletionOct 23, 2017
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 17.2 years ago
Interventions
Everolimusdrug
Everolimus was administered in a continuous oral daily dosing of 10 mg (two 5-mg tablets).
Placebodrug
Everolimus placebo was administered in a continuous oral daily dosing of 10 mg (two 5-mg tablets).
Trastuzumabdrug
Trastuzumab, 2 mg/kg weekly was used intravenously.
Paclitaxeldrug
Paclitaxel, 80 mg/m2 weekly was used intravenously.