HERVIN: Trastuzumab and Vinorelbine in Metastatic Breast Cancer

National Cancer Institute, Naples

Status and phase: Completed; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: trastuzumab; Drug: vinorelbine

Study type: Interventional

Funder types: Other

Identifiers

NCT00401427

HERVIN

Details and patient eligibility

About

The combination of vinorelbine with weekly trastuzumab has produced high response rate in HER2 overexpressing metastatic breast cancer (MBC). The present phase 2 study was planned to test activity of the same combination, with trastuzumab given every 3 weeks, rather than weekly.

Full description

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)