Metastatic Breast CancerPhase 2NCT00250874
Myocet, Docetaxel & Trastuzumab as 1st Line Treatment of Patients With HER-2/Neu Positive Metastatic Breast Cancer
A Phase 2 study testing Liposomal Doxorubicin (Myocet), Docetaxel and Trastuzumab in people with Metastatic Breast Cancer, run by Zeneus Pharma at 1 site in Italy.
Trial summary
To study the pharmacokinetic profile of the therapeutic schedule in order to demonstrate absence of negative interactions among the 3 drugs administered Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Liposomal Doxorubicin (Myocet), Docetaxel and Trastuzumab
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2003to 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HER-2/neu overexpression assessed by FISH test or with immunohistochemical methods: Dako(the result must be 3+ with dakotest); if the immunohistochemical test results 2+ it is needed a positive FISH test
- Female < 70yrs
- Histologically or cytologically proven breast cancer.
- Metastatic or locally advanced breast cancer (clinical stage: III-IV)
- Adequate hematological, hepatic, renal and cardiac function, the latter confirmed by echocardiography with FEVS ≥50%
- Prior adjuvant chemotherapy if doxorubicin total dose ≤300 mg/m2, epirubicin total dose ≤450 mg/m2
Who cannot join
- History of cardiopathy
- Severe hepatic and renal diseases
- Brain metastases as the only parameter of disease
- Contraindication to the use of corticosteroids as premedication
- Acute infectious diseases
- Insulin-dependent diabetes
- History of other cancers except for adequately treated basal cell skin cancer or in situ carcinoma of the cervix
- Concurrent treatment with any other cancer therapy
Trial locations and contacts
1 site in 1 country.
Professor Gasparini contact
About this study
Official title: Phase I-II Study of Liposomal Doxorubicin (Myocet®), Docetaxel and Trastuzumab as First-Line Treatment of Patients With HER-2/Neu Positive Metastatic Breast Cancer
To study the pharmacokinetic profile of the therapeutic schedule in order to demonstrate absence of negative interactions among the 3 drugs administered
Read the detailed description
- To assess the maximum tolerated dose (MTD) of Myocet at different dosages in combination with Taxotere at the fixed dose of 35 mg/m2 on day 2 and 9 every 21 days and weekly Herceptin as first line therapy in patients affected by HER-2/neu positive metastatic breast cancer
- To enhance the proportion of complete remission
- To allow the feasibility of the combination of Herceptin with both Myocet and Taxotere without an enhanced risk of cardiotoxicity
- Conditions
- Metastatic Breast Cancer
- Being tested
- Liposomal Doxorubicin (Myocet), Docetaxel and Trastuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal Doxorubicin (Myocet), Docetaxel and TrastuzumabDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2005 (estimated)
- Study startDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 45 participants
Sponsor and investigators
- Lead sponsor
- Zeneus Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Professor Amadori, Principal investigator, Ospedale Pietrantoni, Forli, ItalyProfessor Gasparini, Principal investigator, San Filippo Neri, Rome, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00250874
- Sponsor's protocol ID
- Myocet 008 (L017)
- Status last verified
- Nov 2005
- First submitted
- 7 Nov 2005
- Last updated
- 8 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II Study of Liposomal Doxorubicin (Myocet®), Docetaxel and Trastuzumab as First-Line Treatment of Patients With HER-2/Neu Positive Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00250874
- Acronym / sponsor ID
- Myocet 008 (L017)
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants
- Lead sponsor
- Zeneus PharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- First posted
- 8 Nov 2005 (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.
To study the pharmacokinetic profile of the therapeutic schedule in order to demonstrate absence of negative interactions among the 3 drugs administered
Detailed description
- To assess the maximum tolerated dose (MTD) of Myocet at different dosages in combination with Taxotere at the fixed dose of 35 mg/m2 on day 2 and 9 every 21 days and weekly Herceptin as first line therapy in patients affected by HER-2/neu positive metastatic breast cancer
- To enhance the proportion of complete remission
- To allow the feasibility of the combination of Herceptin with both Myocet and Taxotere without an enhanced risk of cardiotoxicity
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HER-2/neu overexpression assessed by FISH test or with immunohistochemical methods: Dako(the result must be 3+ with dakotest); if the immunohistochemical test results 2+ it is needed a positive FISH test
- Female < 70yrs
- Histologically or cytologically proven breast cancer.
- Metastatic or locally advanced breast cancer (clinical stage: III-IV)
- Adequate hematological, hepatic, renal and cardiac function, the latter confirmed by echocardiography with FEVS ≥50%
Key exclusion criteria (8 listed)
- History of cardiopathy
- Severe hepatic and renal diseases
- Brain metastases as the only parameter of disease
- Contraindication to the use of corticosteroids as premedication
- Acute infectious diseases
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 |
|---|---|---|
| Liposomal Doxorubicin (Myocet), Docetaxel and Trastuzumab | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2005.
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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.
Professor Gasparini contact
Professor Amadori principal investigator
Ospedale Pietrantoni, Forli, Italy
Professor Gasparini principal investigator
San Filippo Neri, Rome, Italy
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 Liposomal Doxorubicin (Myocet), Docetaxel and Trastuzumab in people with Metastatic Breast Cancer, run by Zeneus Pharma at 1 site in Italy.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 8 Nov 2005. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Professor Amadori (+39 0543 731737, segronco@ausl.fo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 8 Nov 2005.