Topoisomerase II Alpha Gene Amplification and Protein Overexpression Predicting Efficacy of Epirubicin

• Status: Terminated
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jules Bordet Institute
• Collaborators: Centre Hospitalier du Luxembourg; Centre Paul Strauss; Clinique Louis Cathy - Baudour - Belgium; Clinique Saint Pierre - Ottignies -Belgium; Clinique Saint Pierre Ottignies; Clinique Ste Elisabeth - Namur - Belgium; Feculdade de Medicina da Universidade de Sao Paulo - Brasil; Gustave Roussy, Cancer Campus, Grand Paris; HIS - Site Etterbeek - Ixelles - Belgium; University Hospital of Crete
• Treatments: Epirubicin

Criteria

Inclusion Criteria:

1. Histologically-confirmed breast cancer (operable, locally advanced or inflammatory)

2. Age less than 70 years

3. Female patient

4. Tumor size 2 cm at ultrasound examination.

5. ER-negative tumors defined according to immunohistochemistry (i.e. < 10% of positive cells after immunostaining).

6. Multifocal and multicentric breast tumors are allowed if all foci are ER-negative.

7. 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).

8. Written informed consent before study registration.

9. Performance status 0 or 1 (ECOG scale)

10. Normal CBC, hepatic and renal functions

11. Normal left ventricular ejection fraction by echocardiography or muga scan

12. 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 Criteria:

1. Metastatic breast cancer

2. Serious medical conditions like:

1. congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled arrhythmias.

2. history of significant neurologic or psychiatric disorders

3. active uncontrolled infection

4. active peptic ulcer, unstable diabetes mellitus

3. Concomitant contralateral invasive breast cancer

4. Concurrent treatment with hormonal replacement therapy

5. Concurrent treatment with any other anti-cancer therapy

6. Previous treatment with anthracyclines for breast cancer