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Trial Title:
Myocet, Docetaxel & Trastuzumab as 1st Line Treatment of Patients With HER-2/Neu Positive Metastatic Breast Cancer
NCT ID:
NCT00250874
Condition:
Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Docetaxel
Doxorubicin
Liposomal doxorubicin
Trastuzumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Liposomal Doxorubicin (Myocet), Docetaxel and Trastuzumab
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:
1. 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
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
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ospedale Pietrantoni
Address:
City:
Forli
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Professor Amadori
Email:
Principal Investigator
Start date:
December 2003
Lead sponsor:
Agency:
Zeneus Pharma
Agency class:
Industry
Source:
Zeneus Pharma
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00250874
