Metastatic Breast Cancer
Conditions
Keywords
HER2 overexpression, combination therapy
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 the same combination, with trastuzumab given every 3 weeks, rather than weekly.
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, while trastuzumab can be continued until progression. This study is a single-stage phase 2 design, and patients eligible for response evaluation are required.
Interventions
DRUGtrastuzumab
DRUGvinorelbine
Sponsors
National Cancer Institute, Naples
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
| toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| time to progression | — |
| overall survival | — |
Outcome results
None listed