Status:
TERMINATED
Topoisomerase II Alpha Gene Amplification and Protein Overexpression Predicting Efficacy of Epirubicin
Lead Sponsor:
Jules Bordet Institute
Collaborating Sponsors:
Gustave Roussy, Cancer Campus, Grand Paris
Centre Paul Strauss
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
prospective evaluation of topoisomerase II alpha gene amplification and protein overexpression as markers predicting the efficacy of epirubicin in the primary treatment of breast cancer patients.
Detailed Description
Clinical evaluation of topo II a as a predictive marker: Preliminary results from a clinical study suggest that complete remission after treatment with anthracyclines for advanced breast cancer is obs...
Eligibility Criteria
Inclusion
- Histologically-confirmed breast cancer (operable, locally advanced or inflammatory)
- Age less than 70 years
- Female patient
- Tumor size 2 cm at ultrasound examination.
- ER-negative tumors defined according to immunohistochemistry (i.e. \< 10% of positive cells after immunostaining).
- Multifocal and multicentric breast tumors are allowed if all foci are ER-negative.
- Fixed and frozen samples from the primary tumor, obtained before treatment with epirubicin, must be available for evaluation of biological markers (topo II alpha gene and protein, HER-2 gene, p-53 gene, oligonucleotides microarrays).
- Written informed consent before study registration.
- Performance status 0 or 1 (ECOG scale)
- Normal CBC, hepatic and renal functions
- Normal left ventricular ejection fraction by echocardiography or muga scan
- Negative pregnancy test for all women of childbearing potential. Patients of childbearing potential must implement adequate non-hormonal measures to avoid pregnancy during treatment.
Exclusion
- Metastatic breast cancer
- Serious medical conditions like:
- congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled arrhythmias.
- history of significant neurologic or psychiatric disorders
- active uncontrolled infection
- active peptic ulcer, unstable diabetes mellitus
- Concomitant contralateral invasive breast cancer
- Concurrent treatment with hormonal replacement therapy
- Concurrent treatment with any other anti-cancer therapy
- Previous treatment with anthracyclines for breast cancer
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2009
Estimated Enrollment :
338 Patients enrolled
Trial Details
Trial ID
NCT00162812
Start Date
January 1 2003
End Date
April 1 2009
Last Update
July 18 2008
Active Locations (1)
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1
Jules Bordet Institute
Brussels, Belgium, 1000