HERVIN: Trastuzumab and Vinorelbine in Metastatic Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Single-centre Phase 2 Study of Vinorelbine Plus 3-weekly Trastuzumab in Metastatic Breast Cancer Overexpressing Her-2

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: trastuzumab
* Drug: vinorelbine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: trastuzumab|nan|
|Drug: vinorelbine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  |  | 
| toxicity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to progression |  |  | 
| overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HER2 overexpression, combination therapy