HERVIN: Trastuzumab and Vinorelbine in Metastatic Breast Cancer
July 12, 2012 updated by: National Cancer Institute, Naples
A Single-centre Phase 2 Study of Vinorelbine Plus 3-weekly Trastuzumab in Metastatic Breast Cancer Overexpressing Her-2
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
50
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
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response rate
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toxicity
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Secondary Outcome Measures
Outcome Measure |
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overall survival
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time to progression
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2002
Primary Completion (Actual)
June 1, 2006
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
November 17, 2006
First Submitted That Met QC Criteria
November 17, 2006
First Posted (Estimate)
November 20, 2006
Study Record Updates
Last Update Posted (Estimate)
July 13, 2012
Last Update Submitted That Met QC Criteria
July 12, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HERVIN
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