Status:
COMPLETED
HERVIN: Trastuzumab and Vinorelbine in Metastatic Breast Cancer
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed 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, w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00401427
Start Date
November 1 2002
End Date
December 1 2006
Last Update
July 13 2012
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