Metastatic Breast CancerPhase 2NCT00401427
HERVIN: Trastuzumab and Vinorelbine in Metastatic Breast Cancer
A Phase 2 study testing trastuzumab and vinorelbine in people with Metastatic Breast Cancer, run by National Cancer Institute, Naples.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- trastuzumab and vinorelbine
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Dec 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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
About this study
Official title: A Single-centre Phase 2 Study of Vinorelbine Plus 3-weekly Trastuzumab in Metastatic Breast Cancer Overexpressing Her-2
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.
Read the 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
- Being tested
- trastuzumab, vinorelbine
- Keywords
- HER2 overexpression, combination therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trastuzumabDrug
vinorelbineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
toxicity
Secondary outcomes (2)
time to progression
overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2006 (estimated)
- Study startNov 2002
- Primary completionJun 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea De Matteis, M.D., Principal investigator, NCI Naples, Division of Medical Oncology CFrancesco Perrone, M.D., Ph.D., Principal investigator, NCI Naples, Clinical Trials Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401427
- Sponsor's protocol ID
- HERVIN
- Status last verified
- Jul 2012
- First submitted
- 17 Nov 2006
- Last updated
- 13 Jul 2012
- Results posted
- No
Publications
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.
PubMed 17374151
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre Phase 2 Study of Vinorelbine Plus 3-weekly Trastuzumab in Metastatic Breast Cancer Overexpressing Her-2
- ClinicalTrials.gov ID
- NCT00401427
- Acronym / sponsor ID
- HERVIN
- Conditions
- Metastatic Breast Cancer
- Keywords
- HER2 overexpression, combination therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- Nov 2002
- Primary completion
- Jun 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 20 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trastuzumab | Drug | – |
| vinorelbine | Drug | – |
Primary outcome
response rate
toxicity
2 secondary outcomes
time to progression
overall survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2012.
- Results publication: PubMed 17374151De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea De Matteis, M.D. principal investigator
NCI Naples, Division of Medical Oncology C
Francesco Perrone, M.D., Ph.D. principal investigator
NCI Naples, Clinical Trials Unit
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing trastuzumab and vinorelbine in people with Metastatic Breast Cancer, run by National Cancer Institute, Naples.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00401427, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2012.