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Trastuzumab Optimization Trial in Breast Cancer

NCT00637325 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2008-03-17

No results posted yet for this study

Summary

This is an open-label, randomised phase III, multicentre, Italian study designed to investigate the role of trastuzumab in patients with locally advanced and/or metastatic breast cancer over expressing HER2 who received a first line chemotherapy containing trastuzumab. The trial in divided in two studies: 1. The maintenance study will be conducted in patients not progressing to a first line chemotherapy plus trastuzumab. 2. The 2nd line study will be conducted in patients progressing to a first line chemotherapy plus trastuzumab.

Conditions

  • Metastatic or Locally Advanced Breast Cancer

Interventions

DRUG

trastuzumab

In the maintenance study trastuzumab will be administrated once every 3 weeks at the dose of 6 mg/kg by intravenous infusion over 90 minutes until progression of disease. In the 2nd line study, to accomplish the schedule of concomitant second line chemotherapy, trastuzumab will be given on a weekly (2 mg/kg) or a 3-weekly (6 mg/kg).

Sponsors & Collaborators

  • Mario Negri Institute for Pharmacological Research

    collaborator OTHER

  • Istituto Clinico Humanitas

    collaborator OTHER

  • Regione Lombardia

    lead OTHER

Principal Investigators

  • Armando Santoro, MD · Istituto Clinico Humanitas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-05-31
Completion
2011-04-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

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 NCT00637325 on ClinicalTrials.gov