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

A Randomised Phase III Study of Trastuzumab-Docetaxel vs Trastuzumab-Vinorelbine as 1. Line Therapy for Patients With Metastatic HER2 Positive Breast Cancer

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00430001

Enrollment

300

Registered

2007-02-01

Start date

2005-05-31

Completion date

2008-12-31

Last updated

2008-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Metastatic breast neoplasm

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.

Interventions

DRUGdocetaxel

DRUGvinorelbine

DRUGtrastuzumab

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 74 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Disease free survival	median

Secondary

Measure	Time frame
response rate, overall survival, toxicity	Median

Countries

Denmark

Contacts

Primary ContactMichael Andersson, MD D Med Sci

michael.andersson@dadlnet.dk+45 35458105

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026