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

NCT ID: NCT00430001

Last Updated: 2008-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Keywords

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Metastatic breast neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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docetaxel

Intervention Type DRUG

vinorelbine

Intervention Type DRUG

trastuzumab

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role collaborator

Danish Breast Cancer Cooperative Group

OTHER

Sponsor Role lead

Principal Investigators

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Michael Andersson, MD D Med Sci

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology 5074, Rigshospitalet, 2100 Copenhagen, Denmark

Locations

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Department of Oncology, Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Michael Andersson, MD D Med Sci

Role: CONTACT

Phone: +45 35458105

Email: [email protected]

Other Identifiers

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HERNATA

Identifier Type: -

Identifier Source: org_study_id