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

This study has been terminated.
(Low accrual rate)
Sponsor:
Collaborators:
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
Information provided by:
Jules Bordet Institute
ClinicalTrials.gov Identifier:
NCT00162812
First received: September 9, 2005
Last updated: July 16, 2008
Last verified: July 2008
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Epirubicin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Jules Bordet Institute:

Primary Outcome Measures:
  • correlation of topoisomerase II and pathologic complete response [ Time Frame: pCR at surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 338
Study Start Date: January 2003
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Epirubicin
    100 mg/m² every three weeks (4 cycles) or every two weeks (6 cycles)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162812

Locations
Belgium
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
Investigators
Principal Investigator: Veronique D'Hondt, MD, PhD Jules Bordet Institute
Study Chair: Martine Piccart, MD, PhD Jules Bordet Institute
  More Information

No publications provided

Responsible Party: Veronique D'Hondt, Jules Bordet Institute
ClinicalTrials.gov Identifier: NCT00162812     History of Changes
Other Study ID Numbers: TOP Trial, CE1141
Study First Received: September 9, 2005
Last Updated: July 16, 2008
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Epirubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014