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 because the information has not been verified recently.
Verified May 2008 by Danish Breast Cancer Cooperative Group.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Hoffmann-La Roche
Sanofi
Information provided by:
Danish Breast Cancer Cooperative Group
ClinicalTrials.gov Identifier:
NCT00430001
First received: January 30, 2007
Last updated: May 6, 2008
Last verified: May 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 74 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00430001     History of Changes
Other Study ID Numbers: HERNATA
Study First Received: January 30, 2007
Last Updated: May 6, 2008
Health Authority: Denmark: Danish Medicines Agency

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
Vinorelbine
Docetaxel
Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014