A Single-centre Phase 2 Study of Vinorelbine Plus 3-weekly Trastuzumab in Metastatic Breast Cancer Overexpressing Her-2
18 Years
N/A
Female
Metastatic Breast Cancer
Trial Information
A Single-centre Phase 2 Study of Vinorelbine Plus 3-weekly Trastuzumab in Metastatic Breast Cancer Overexpressing Her-2
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
response rate
Principal Investigator
Andrea De Matteis, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
NCI Naples, Division of Medical Oncology C
Authority:
Italy: Ethics Committee
Study ID:
HERVIN
NCT ID:
NCT00401427
Start Date:
November 2002
Completion Date:
December 2006
Related Keywords:
- Metastatic Breast Cancer
- HER2 overexpression
- combination therapy
- Breast Neoplasms
Name | Location |
|---|
