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Everolimus in Combination With Trastuzumab and Paclitaxel in the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer

NCT00876395 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 719

Last updated 2018-12-19

Study results available
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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.

Conditions

Interventions

DRUG

Everolimus

Everolimus was administered in a continuous oral daily dosing of 10 mg (two 5-mg tablets).

DRUG

Placebo

Everolimus placebo was administered in a continuous oral daily dosing of 10 mg (two 5-mg tablets).

DRUG

Trastuzumab

Trastuzumab, 2 mg/kg weekly was used intravenously.

DRUG

Paclitaxel

Paclitaxel, 80 mg/m2 weekly was used intravenously.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-10
Primary Completion
2014-05-30
Completion
2017-10-23
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • 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
  • Venezuela

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00876395 on ClinicalTrials.gov