Carcinoma Breast Stage IVPhase 2NCT00433095
Vinorelbine (Oral) Plus Trastuzumab for 1st-line Treatment of HER2/Neu Overexpressing Breast Cancer
A Phase 2 study testing Navelbine, Herceptin and Navelbine (oraly) in people with Carcinoma Breast Stage IV, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
1st-line treatment of HER2/neu overexpressing breast cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Carcinoma Breast Stage IV
- What is being tested?
- Navelbine, Herceptin and Navelbine (oraly)
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- 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 to 75 years
- Women only
- Adult, Older adult
Who may be able to join
- Histologically proven, metastatic breats cancer.
- HER2-neu overexpression (IHC3+ or IHC2+/FISH+)
- Written informed consent
- no previous therapy with vinorelbine or trastuzumab
- Age * 18 and * 75 years
- Karnofsky-Performance status > 70%
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- Life expectance 16 weeks and more
- Availability of at least one target lesion according to RECIST-criteria. Target lesions need to be outside of radiation fields. Bone metastases are excluded as indicator leasions
- Exclusion of pregnancy and adequte contraception during childbearing age.
- Adequate hematological, renal, and hepatic function
- Normal cardiac function. LVEF should not be >10% below normal.
- Adequate compliance to perform treatment and subsequent follow-up visits
Who cannot join
- Locoregional recurrence of breast cancer only or development of contralateral breast cancer
- Pregnancy or lactation
- Symptomatic brain- or meningeal metastasis
- Concurrent endocrine antitumor therapy
- Other malignancies except basal cell cancer of the skin or in-situ carcinoma of the cervix
- Peripheral neuropathy >= NCI CTC Grade 2.
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- other severel disease which preclude adequate treatment
- Participation in a clinical trial within the last 30 days.
- Psychological, familial, sociological or geographical conditions which preclude treatment according to the protocol or the planned follow-up
Trial locations and contacts
1 site in 1 country.
About this study
1st-line treatment of HER2/neu overexpressing breast cancer
Read the detailed description
The combination of vinorelbine and trastuzumab was demonstrated to be highly effective in several trials showing response rates in the range of 59-78%. This combination is characterized by good tolerability and can be applied for a prolonged period without the risk of major cumulative toxicity The availability of oral vinorelbine promises a further simplification of therapy. The present trial therefore investigates the safety and efficacy of a combined treatment with trastuzumab and oral vinorelbine.
- Conditions
- Carcinoma Breast Stage IV
- Being tested
- Navelbine, Herceptin, Navelbine (oraly)
- Keywords
- Navelbine, Herceptin, oral, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NavelbineDrug
HerceptinDrug
Navelbine (oraly)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Secondary outcomes (3)
Time to tumor progression
Overall survival
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma Breast Stage IVStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Pierre Fabre Laboratories
- Investigators
- Volker Heinemann, PhD, MD, Principal investigator, University of Munich - Klinikum GrosshadernHans-Joachim Stemmler, PhD, MD, Study chair, University of Munich - Klinikum Grosshadern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00433095
- Sponsor's protocol ID
- Mamma-2-2004
- Status last verified
- Feb 2007
- First submitted
- 7 Feb 2007
- Last updated
- 14 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vinorelbine (Oral) Plus Trastuzumab for 1st-line Treatment of HER2/Neu Overexpressing Breast Cancer
- ClinicalTrials.gov ID
- NCT00433095
- Acronym / sponsor ID
- Mamma-2-2004
- Conditions
- Carcinoma Breast Stage IV
- Keywords
- Navelbine, Herceptin, oral, breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Pierre Fabre Laboratories
- First posted
- 9 Feb 2007 (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.
1st-line treatment of HER2/neu overexpressing breast cancer
Detailed description
The combination of vinorelbine and trastuzumab was demonstrated to be highly effective in several trials showing response rates in the range of 59-78%. This combination is characterized by good tolerability and can be applied for a prolonged period without the risk of major cumulative toxicity The availability of oral vinorelbine promises a further simplification of therapy. The present trial therefore investigates the safety and efficacy of a combined treatment with trastuzumab and oral vinorelbine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically proven, metastatic breats cancer.
- HER2-neu overexpression (IHC3+ or IHC2+/FISH+)
- Written informed consent
- no previous therapy with vinorelbine or trastuzumab
- Age * 18 and * 75 years
Key exclusion criteria (9 listed)
- Locoregional recurrence of breast cancer only or development of contralateral breast cancer
- Pregnancy or lactation
- Symptomatic brain- or meningeal metastasis
- Concurrent endocrine antitumor therapy
- Other malignancies except basal cell cancer of the skin or in-situ carcinoma of the cervix
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 |
|---|---|---|
| Navelbine | Drug | – |
| Herceptin | Drug | – |
| Navelbine (oraly) | Drug | – |
Primary outcome
Response rate
3 secondary outcomes
Time to tumor progression
Overall survival
Safety
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 14 Mar 2011.
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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.
Volker Heinemann, PhD, MD principal investigator
University of Munich - Klinikum Grosshadern
Hans-Joachim Stemmler, PhD, MD study chair
University of Munich - Klinikum Grosshadern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Navelbine, Herceptin and Navelbine (oraly) in people with Carcinoma Breast Stage IV, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 12 inclusion and 9 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 14 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2011.