Back to resultsMyocet, Docetaxel & Trastuzumab as 1st Line Treatment of Patients With HER-2/Neu Positive Metastatic Breast Cancer
Primary Purpose
Metastatic Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Liposomal Doxorubicin (Myocet), Docetaxel and Trastuzumab
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Ospedale PietrantoniRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00250874
Brief Title
Myocet, Docetaxel & Trastuzumab as 1st Line Treatment of Patients With HER-2/Neu Positive Metastatic Breast Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Unknown status
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Zeneus Pharma
4. Oversight
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Liposomal Doxorubicin (Myocet), Docetaxel and Trastuzumab
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Professor Amadori
Phone
+39 0543 731737
Email
segronco@ausl.fo.it
First Name & Middle Initial & Last Name or Official Title & Degree
Professor Gasparini
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor Amadori
Organizational Affiliation
Ospedale Pietrantoni, Forli, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Professor Gasparini
Organizational Affiliation
San Filippo Neri, Rome, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Pietrantoni
City
Forli
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Professor Amadori
12. IPD Sharing Statement
Learn more about this trial
Myocet, Docetaxel & Trastuzumab as 1st Line Treatment of Patients With HER-2/Neu Positive Metastatic Breast Cancer
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