HERVIN: Trastuzumab and Vinorelbine in Metastatic Breast Cancer
This study has been completed.
Sponsor:
National Cancer Institute, Naples
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT00401427
First received: November 17, 2006
Last updated: July 12, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Breast Cancer |
Drug: trastuzumab Drug: vinorelbine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Single-centre Phase 2 Study of Vinorelbine Plus 3-weekly Trastuzumab in Metastatic Breast Cancer Overexpressing Her-2 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute, Naples:
Primary Outcome Measures:
- response rate
- toxicity
Secondary Outcome Measures:
- time to progression
- overall survival
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2002 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00401427
Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
| Principal Investigator: | 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 |
More Information
Publications:
| Responsible Party: | National Cancer Institute, Naples |
| ClinicalTrials.gov Identifier: | NCT00401427 History of Changes |
| Other Study ID Numbers: | HERVIN |
| Study First Received: | November 17, 2006 |
| Last Updated: | July 12, 2012 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by National Cancer Institute, Naples:
|
HER2 overexpression combination therapy |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Vinorelbine |
Trastuzumab Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013