Metastatic Breast Cancer Clinical Trial
Official title:
A Single-centre Phase 2 Study of Vinorelbine Plus 3-weekly Trastuzumab in Metastatic Breast Cancer Overexpressing Her-2
Verified date | July 2012 |
Source | National Cancer Institute, Naples |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 2006 |
Est. primary completion date | June 2006 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute, Naples |
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 Mat — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | response rate | |||
Primary | toxicity | |||
Secondary | time to progression | |||
Secondary | overall survival |
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