Clinical trial NCT00401427: HERVIN: Trastuzumab and Vinorelbine in Metastatic Breast Cancer
Official title: A Single-centre Phase 2 Study of Vinorelbine Plus 3-weekly Trastuzumab in Metastatic Breast Cancer Overexpressing Her-2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Keywords: HER2 overexpression
combination therapy
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2006-11-20
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: response rate
measure: toxicity
Secondary outcomes:
measure: time to progression
measure: overall survival
Other outcomes:
Locations:
Study officials:
affiliation: NCI Naples, Division of Medical Oncology C
name: Andrea De Matteis, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: NCI Naples, Clinical Trials Unit
name: Francesco Perrone, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.