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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by Danish Breast Cancer Cooperative Group.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00430001
First Posted: February 1, 2007
Last Update Posted: May 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hoffmann-La Roche
Sanofi
Information provided by:
Danish Breast Cancer Cooperative Group
  Purpose
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 Intervention Phase
Breast Cancer Drug: docetaxel Drug: vinorelbine Drug: trastuzumab Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Danish Breast Cancer Cooperative Group:

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

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

Estimated Enrollment: 300
Study Start Date: May 2005
Estimated Study Completion Date: December 2008
  Eligibility

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
Criteria

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
  Contacts and Locations
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


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

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

ClinicalTrials.gov Identifier: NCT00430001     History of Changes
Other Study ID Numbers: HERNATA
First Submitted: January 30, 2007
First Posted: February 1, 2007
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
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Vinorelbine
Trastuzumab
Vinblastine
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic