HERVIN: Trastuzumab and Vinorelbine in Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute, Naples
• Treatments: Trastuzumab; Vinblastine; Vinorelbine

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