HERVIN: Trastuzumab and Vinorelbine in Metastatic Breast Cancer

NCT00401427 | Completed Phase 2

• 1 other identifier: HERVIN
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metastatic Breast Cancer

Keywords

HER2 overexpression; combination therapy

Outcome Measures

Primary Outcomes (2)

• response rate

• toxicity

Secondary Outcomes (2)

• time to progression

• overall survival

Interventions

trastuzumab DRUG

vinorelbine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Related Publications (1)

• De Maio E, Pacilio C, Gravina A, Morabito A, Di Rella F, Labonia V, Landi G, Nuzzo F, Rossi E, Silvestro P, Botti G, Di Bonito M, Curcio MP, Formichelli F, La Vecchia F, Staiano M, Maurea N, D'Aiuto G, D'Aiuto M, Thomas R, Signoriello G, Perrone F, de Matteis A. Vinorelbine plus 3-weekly trastuzumab in metastatic breast cancer: a single-centre phase 2 trial. BMC Cancer. 2007 Mar 20;7:50. doi: 10.1186/1471-2407-7-50.

  PMID: 17374151 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2006
• First Posted: November 20, 2006
• Study Start: November 1, 2002
• Primary Completion: June 1, 2006
• Study Completion: December 1, 2006
• Last Updated: July 13, 2012

Record last verified: 2012-07