Vinorelbine Plus (+) Trastuzumab vs Docetaxel Plus (+) Trastuzumab as 1 Line Treatment for HER2 Positive (+) Metastatic Breast Cancer

NCT00430001 | Unknown Phase 3

• 1 other identifier: HERNATA
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

In an open-label randomised phase III-trial patients with metastatic HER2-positive breast cancer naive to chemotherapy with normal organ function and WHO performance status \< 3 are randomised to receive either docetaxel 100 mg/m2 i.v. plus trastuzumab 6 mg/kg (8 mg/kg loading dose) q 3 weeks or vinorelbine 30 or 35 mg/m2 days 1+8 plus trastuzumab 6 mg/kg (8 mg/kg loading dose) q 3 weeks. Primary endpoint is time to progression. Secondary endpoints include overall survival, time to treatment failure, response rate, duration of response and toxicity. The study hypothesis is that docetaxel is more efficient than vinorelbine but also more toxic.

Conditions

Breast Cancer

Keywords

Metastatic breast neoplasm

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  median

Secondary Outcomes (1)

• response rate, overall survival, toxicity

  Median

Interventions

docetaxel DRUG

vinorelbine DRUG

trastuzumab DRUG

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Locally advanced or metastatic HER2-positive breast cancer
• WHO performance status \< 3

You may not qualify if:

• Chemotherapy for metastatic breast cancer or adjuvant therapy within 12 months with docetaxel, vinorelbine or trastuzumab
• Severe dyspnoea
• Abnormal organ function including cardiac

Sponsors & Collaborators

• Danish Breast Cancer Cooperative Group: lead
• Hoffmann-La Roche: collaborator
• Sanofi: collaborator

Study Sites (1)

Department of Oncology, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Vinorelbine; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Michael Andersson, MD D Med Sci

  Department of Oncology 5074, Rigshospitalet, 2100 Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Andersson, MD D Med Sci

CONTACT

+45 35458105; michael.andersson@dadlnet.dk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 30, 2007
• First Posted: February 1, 2007
• Study Start: May 1, 2005
• Study Completion: December 1, 2008
• Last Updated: May 9, 2008

Record last verified: 2008-05

Locations

DK (1)