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Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer

NCT01007942 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 569

Last updated 2017-04-05

Study results available
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Summary

This phase III, double-blind, placebo-controlled multinational study will assess the combination everolimus, vinorelbine, and trastuzumab compared to the combination vinorelbine and trastuzumab with respect to progressive-free survival and over survival in HER2/neu positive women with locally advanced or metastatic breast cancer who are resistant to trastuzumab and have been pre-treated with a taxane.

Conditions

Interventions

DRUG

everolimus

Oral everolimus was taken once 5 mg/day (2 × 2.5 mg tablets) and were packaged into blister packs.

DRUG

Placebo

Oral everolimus placebo was taken once 5 mg/day (2 × 2.5 mg tablets) and were packaged into blister packs.

DRUG

vinorelbine

intravenous vinorelbine (25 mg/m2 weekly)

DRUG

trastuzumab

intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • China
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Japan
  • Mexico
  • Poland
  • Singapore
  • Slovakia
  • Spain
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

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 NCT01007942 on ClinicalTrials.gov