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

Danish Breast Cancer Cooperative Group (DBCG)

Status and phase: Unknown; Phase 3

Conditions: Breast Cancer

Treatments: Drug: vinorelbine; Drug: docetaxel; Drug: trastuzumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00430001

HERNATA

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 74 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)