COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

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. 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

Layout table for study information
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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
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 identifier (NCT number): NCT00430001

Layout table for location contacts
Contact: Michael Andersson, MD D Med Sci +45 35458105

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

Layout table for additonal information Identifier: NCT00430001    
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:
Layout table for 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, Immunological
Antineoplastic Agents, Phytogenic