HERVIN: Trastuzumab and Vinorelbine in Metastatic Breast Cancer

NCT ID: NCT00401427

Last Updated: 2012-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2006-12-31

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.

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.

Conditions

Metastatic Breast Cancer

Keywords

HER2 overexpression; combination therapy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

trastuzumab

Intervention Type: DRUG

vinorelbine

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Naples

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea De Matteis, M.D.

Role: PRINCIPAL_INVESTIGATOR

NCI Naples, Division of Medical Oncology C

Francesco Perrone, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

NCI Naples, Clinical Trials Unit

References

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.

Reference Type: RESULT

PMID: 17374151 (View on PubMed)

Other Identifiers

HERVIN

Identifier Type: -

Identifier Source: org_study_id