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

• Sponsor: Danish Breast Cancer Cooperative Group (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00430001
• Collaborator: Hoffmann-La Roche (Industry), Sanofi (Industry)
• Enrollment: 300
• Location: 1
• Duration (Months): 43
• Patients Per Site Per Month: 7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: docetaxel; Drug: vinorelbine; Drug: trastuzumab	Phase 3

Study Design

• Study Type: Interventional
• Anticipated 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 1, 2005
• Anticipated Study Completion Date: Dec 1, 2008

Outcome Measures

Primary Outcome Measures

1. Disease free survival [median]

Secondary Outcome Measures

1. response rate, overall survival, toxicity [Median]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 74 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Oncology, Rigshospitalet	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00430001
• Other Study ID Numbers: HERNATA
• First Posted: Feb 1, 2007
• Last Update Posted: May 9, 2008
• Last Verified: May 1, 2008

• Keywords provided by , ,: Metastatic breast neoplasm
• Additional relevant MeSH terms: Breast Neoplasms; Docetaxel; Trastuzumab; Vinorelbine

Study Results

No Results Posted as of May 9, 2008