HERVIN: Trastuzumab and Vinorelbine in Metastatic Breast Cancer

Launched by NATIONAL CANCER INSTITUTE, NAPLES · Nov 17, 2006

Keywords

ClinConnect Summary

The schedule of treatment includes vinorelbine (30 mg/m2 on days 1 \& 8 every 21 days) and trastuzumab (8 mg/kg on day 1 and then 6 mg/kg every 21 days). Vinorelbine is planned for maximum 9 cycles, while trastuzumab can be continued until progression. This study is a single-stage phase 2 design, and patients eligible for response evaluation are required.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Histologically or cytologically confirmed breast cancer
• • Stage IV
• • No prior or not more than one prior chemotherapy for metastatic disease
• • Overexpression of HER-2 (3+ on immunohistochemical exam) or amplified genetic expression of c-erbB2/neu (positive by Fish method)
• • Performance status 0-2 (ECOG)
• Exclusion Criteria:
• • Absence of measurable disease
• • Life expectancy \< 3 months
• • Concomitant malignancy or malignancy within previous 5 years (except basal cell or spinocellular skin cancer and in situ cervical cancer if they have been adequately treated
• • Previous treatment with trastuzumab or vinorelbine
• • Neutrophils \< 1500/mm3 or platelets \< 100000/mm3 or haemoglobin \< 8 g/dl
• • Creatinine \> 1.5 x the value of the upper normal limit
• • GOT and/or GPT \> 2.5 x the value of the upper normal limit and/or bilirubin \> 1.5 x the value of the upper normal limit in the absence of liver metastases
• • GOT and/or GPT \> 5 x the value of the upper normal limit and/or bilirubin \> 3 x the value of the upper normal limit in the presence of liver metastases
• • Left ventricular ejection fraction \< 50% (measured by ultrasound or MUGA angiography)
• • Concomitant conditions that contraindicate the use of the drugs in the protocol
• • Male gender
• • Pregnancy or lactation·
• • Incapacity or refusal to provide informed consent
• • Inability to comply with followup