HERVIN: Trastuzumab and Vinorelbine in Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT00401427
First received: November 17, 2006
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Metastatic Breast Cancer
Drug: trastuzumab
Drug: vinorelbine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:
  • response rate
  • toxicity

Secondary Outcome Measures:
  • time to progression
  • overall survival

Estimated Enrollment: 50
Study Start Date: November 2002
Study Completion Date: December 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00401427

Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
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
  More Information

Publications:
Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT00401427     History of Changes
Other Study ID Numbers: HERVIN
Study First Received: November 17, 2006
Last Updated: July 12, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by National Cancer Institute, Naples:
HER2 overexpression
combination therapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vinorelbine
Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014