Myocet, Docetaxel & Trastuzumab as 1st Line Treatment of Patients With HER-2/Neu Positive Metastatic Breast Cancer
NCT ID: NCT00250874
Last Updated: 2005-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
45 participants
INTERVENTIONAL
2003-12-31
Brief Summary
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Detailed Description
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2. To enhance the proportion of complete remission
3. To allow the feasibility of the combination of Herceptin with both Myocet and Taxotere without an enhanced risk of cardiotoxicity
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Liposomal Doxorubicin (Myocet), Docetaxel and Trastuzumab
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
70 Years
FEMALE
No
Sponsors
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Zeneus Pharma
INDUSTRY
Principal Investigators
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Professor Amadori
Role: PRINCIPAL_INVESTIGATOR
Ospedale Pietrantoni, Forli, Italy
Professor Gasparini
Role: PRINCIPAL_INVESTIGATOR
San Filippo Neri, Rome, Italy
Locations
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Ospedale Pietrantoni
Forlì, , Italy
Countries
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Central Contacts
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Professor Gasparini
Role: CONTACT
Other Identifiers
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Myocet 008 (L017)
Identifier Type: -
Identifier Source: org_study_id