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HERVIN: Trastuzumab and Vinorelbine in Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00401427
Recruitment Status : Completed
First Posted : November 20, 2006
Last Update Posted : July 13, 2012
Information provided by (Responsible Party):
National Cancer Institute, Naples

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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: trastuzumab Drug: vinorelbine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-centre Phase 2 Study of Vinorelbine Plus 3-weekly Trastuzumab in Metastatic Breast Cancer Overexpressing Her-2
Study Start Date : November 2002
Actual Primary Completion Date : June 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. response rate
  2. toxicity

Secondary Outcome Measures :
  1. time to progression
  2. overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00401427

Sponsors and Collaborators
National Cancer Institute, Naples
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Principal Investigator: Andrea De Matteis, M.D. NCI Naples, Division of Medical Oncology C
Principal Investigator: Francesco Perrone, M.D., Ph.D. NCI Naples, Clinical Trials Unit

Publications of Results:
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Responsible Party: National Cancer Institute, Naples Identifier: NCT00401427     History of Changes
Other Study ID Numbers: HERVIN
First Posted: November 20, 2006    Key Record Dates
Last Update Posted: July 13, 2012
Last Verified: July 2012
Keywords provided by National Cancer Institute, Naples:
HER2 overexpression
combination therapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action