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

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ClinicalTrials.gov Identifier: NCT00430001
Recruitment Status : Unknown
Verified May 2008 by Danish Breast Cancer Cooperative Group.
Recruitment status was:  Recruiting
First Posted : February 1, 2007
Last Update Posted : May 9, 2008
Hoffmann-La Roche
Information provided by:
Danish Breast Cancer Cooperative Group

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: docetaxel Drug: vinorelbine Drug: trastuzumab Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Phase III Study of Trastuzumab-Docetaxel vs Trastuzumab-Vinorelbine as 1. Line Therapy for Patients With Metastatic HER2 Positive Breast Cancer
Study Start Date : May 2005
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Disease free survival [ Time Frame: median ]

Secondary Outcome Measures :
  1. response rate, overall survival, toxicity [ Time Frame: Median ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00430001

Contact: Michael Andersson, MD D Med Sci +45 35458105 michael.andersson@dadlnet.dk

Department of Oncology, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Danish Breast Cancer Cooperative Group
Hoffmann-La Roche
Principal Investigator: Michael Andersson, MD D Med Sci Department of Oncology 5074, Rigshospitalet, 2100 Copenhagen, Denmark

ClinicalTrials.gov Identifier: NCT00430001     History of Changes
Other Study ID Numbers: HERNATA
First Posted: February 1, 2007    Key Record Dates
Last Update Posted: May 9, 2008
Last Verified: May 2008

Keywords provided by Danish Breast Cancer Cooperative Group:
Metastatic breast neoplasm

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic