CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
Everolimus +1 moredrug
Likely dose
Trastuzumab 6 mg/kgfrom 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/NCT00458237
NCT00458237Phase 2Completed

A Brief Dose Escalation Followed by a Phase 2 Study of RAD001 in Combination With Trastuzumab in HER2-Positive Metastatic Breast Cancer

Beth Israel Deaconess Medical Center·interventional·Posted Apr 10, 2007·Updated Oct 20, 2016

In Brief

A Phase 2 clinical trial evaluating Everolimus and Trastuzumab for Breast Cancer. Completed, enrolled 11 participants across 2 sites.

Detailed Summary

The purpose of this research study is to determine the safety of RAD001 and the highest dose of this drug that can be given to people with HER2-positive metastatic breast cancer safely in combination with trastuzumab. RAD001 has been used in patients with severe rheumatoid arthritis, in recipients of solid-organ transplants, healthy volunteers and experiments with animals, and information from those other research studies suggest that this RAD001 may help to stop cancer cells from growing abnormally.

Study Details

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

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 10, 2007
Enrollment StartApr 1, 2007
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 19.2 years ago

Interventions

Everolimusdrug

Everolimus is being administered orally 7 days per week.

Trastuzumabdrug

Trastuzumab is being administered at a dose of 6 mg/kg intravenously once every 21 days.