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A Randomised Phase III Study of Trastuzumab-Docetaxel vs Trastuzumab-Vinorelbine as 1. Line Therapy for Patients With Metastatic HER2 Positive Breast Cancer


Phase 3
18 Years
74 Years
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

A Randomised Phase III Study of Trastuzumab-Docetaxel vs Trastuzumab-Vinorelbine as 1. Line Therapy for Patients With Metastatic HER2 Positive Breast Cancer


Inclusion Criteria:



- Locally advanced or metastatic HER2-positive breast cancer

- WHO performance status < 3

Exclusion Criteria:

- Chemotherapy for metastatic breast cancer or adjuvant therapy within 12 months
with docetaxel, vinorelbine or trastuzumab

- Severe dyspnoea

- Abnormal organ function including cardiac

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease free survival

Outcome Time Frame:

median

Principal Investigator

Michael Andersson, MD D Med Sci

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Oncology 5074, Rigshospitalet, 2100 Copenhagen, Denmark

Authority:

Denmark: Danish Medicines Agency

Study ID:

HERNATA

NCT ID:

NCT00430001

Start Date:

May 2005

Completion Date:

December 2008

Related Keywords:

  • Breast Cancer
  • Metastatic breast neoplasm
  • Breast Neoplasms

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