Back to resultsVinorelbine Plus (+) Trastuzumab vs Docetaxel Plus (+) Trastuzumab as 1 Line Treatment for HER2 Positive (+) Metastatic Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
docetaxel
vinorelbine
trastuzumab
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Metastatic breast neoplasm
Eligibility 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
Sites / Locations
- Department of Oncology, RigshospitaletRecruiting
Outcomes
Primary Outcome Measures
Disease free survival
Secondary Outcome Measures
response rate, overall survival, toxicity
Full Information
NCT ID
NCT00430001
First Posted
January 30, 2007
Last Updated
May 6, 2008
Sponsor
Danish Breast Cancer Cooperative Group
Collaborators
Hoffmann-La Roche, Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT00430001
Brief Title
Vinorelbine Plus (+) Trastuzumab vs Docetaxel Plus (+) Trastuzumab as 1 Line Treatment for HER2 Positive (+) Metastatic Breast Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Danish Breast Cancer Cooperative Group
Collaborators
Hoffmann-La Roche, Sanofi
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Metastatic breast neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
vinorelbine
Intervention Type
Drug
Intervention Name(s)
trastuzumab
Primary Outcome Measure Information:
Title
Disease free survival
Time Frame
median
Secondary Outcome Measure Information:
Title
response rate, overall survival, toxicity
Time Frame
Median
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Andersson, MD D Med Sci
Phone
+45 35458105
Email
michael.andersson@dadlnet.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Andersson, MD D Med Sci
Organizational Affiliation
Department of Oncology 5074, Rigshospitalet, 2100 Copenhagen, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Vinorelbine Plus (+) Trastuzumab vs Docetaxel Plus (+) Trastuzumab as 1 Line Treatment for HER2 Positive (+) Metastatic Breast Cancer
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