Clinical trial · Interventional
HERVIN: Trastuzumab and Vinorelbine in Metastatic Breast Cancer
A Single-centre Phase 2 Study of Vinorelbine Plus 3-weekly Trastuzumab in Metastatic Breast Cancer Overexpressing Her-2
NCT00401427CI-TRIAL-00007425completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| trastuzumab | Drug | Trastuzumab | ALIAS |
| vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- response rate
- measure
- toxicity
Secondary outcomes (2)
- measure
- time to progression
- measure
- overall survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTDe 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