We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00162812
Recruitment Status : Terminated (Low accrual rate)
First Posted : September 13, 2005
Last Update Posted : July 18, 2008
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Epirubicin Phase 2

  Show Detailed Description

Study Design

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

Arms and Interventions

Intervention Details:
    Drug: Epirubicin
    100 mg/m² every three weeks (4 cycles) or every two weeks (6 cycles)

Outcome Measures

Primary Outcome Measures :
  1. correlation of topoisomerase II and pathologic complete response [ Time Frame: pCR at surgery ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

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

Jules Bordet Institute
Brussels, Belgium, 1000
Sponsors and Collaborators
Jules Bordet Institute
Gustave Roussy, Cancer Campus, Grand Paris
Centre Paul Strauss
Centre Hospitalier du Luxembourg
Clinique Louis Cathy - Baudour - Belgium
HIS - Site Etterbeek - Ixelles - Belgium
Clinique Saint Pierre - Ottignies -Belgium
Clinique Ste Elisabeth - Namur - Belgium
University Hospital of Crete
Feculdade de Medicina da Universidade de Sao Paulo - Brasil
Principal Investigator: Veronique D'Hondt, MD, PhD Jules Bordet Institute
Study Chair: Martine Piccart, MD, PhD Jules Bordet Institute
More Information

Responsible Party: Veronique D'Hondt, Jules Bordet Institute
ClinicalTrials.gov Identifier: NCT00162812     History of Changes
Other Study ID Numbers: TOP Trial
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: July 18, 2008
Last Verified: July 2008

Keywords provided by Jules Bordet Institute:
neoadjuvant chemotherapy
early breast cancer
inflammatory breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action