Topoisomerase II Alpha Gene Amplification and Protein Overexpression Predicting Efficacy of Epirubicin (TOP)
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ClinicalTrials.gov Identifier: NCT00162812 |
Recruitment Status :
Terminated
(Low accrual rate)
First Posted : September 13, 2005
Last Update Posted : July 18, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Drug: Epirubicin | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 338 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | January 2003 |
Estimated Primary Completion Date : | December 2008 |
Estimated Study Completion Date : | April 2009 |

- Drug: Epirubicin
100 mg/m² every three weeks (4 cycles) or every two weeks (6 cycles)
- correlation of topoisomerase II and pathologic complete response [ Time Frame: pCR at surgery ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- Metastatic breast cancer
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162812
Belgium | |
Jules Bordet Institute | |
Brussels, Belgium, 1000 |
Principal Investigator: | Veronique D'Hondt, MD, PhD | Jules Bordet Institute | |
Study Chair: | Martine Piccart, MD, PhD | Jules Bordet Institute |
Responsible Party: | Veronique D'Hondt, Jules Bordet Institute |
ClinicalTrials.gov Identifier: | NCT00162812 |
Other Study ID Numbers: |
TOP Trial CE1141 |
First Posted: | September 13, 2005 Key Record Dates |
Last Update Posted: | July 18, 2008 |
Last Verified: | July 2008 |
neoadjuvant chemotherapy early breast cancer inflammatory breast cancer |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Epirubicin |
Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |