NCT00162812

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
338

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Jan 2003

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

July 18, 2008

Status Verified

July 1, 2008

Enrollment Period

5.9 years

First QC Date

September 9, 2005

Last Update Submit

July 16, 2008

Conditions

Breast Cancer

Keywords

neoadjuvant chemotherapyearly breast cancerinflammatory breast cancer

Outcome Measures

Primary Outcomes (1)

  • correlation of topoisomerase II and pathologic complete response

    pCR at surgery

Interventions

EpirubicinDRUG

100 mg/m² every three weeks (4 cycles) or every two weeks (6 cycles)

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jules Bordet Institute

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Breast NeoplasmsInflammatory Breast Neoplasms

Interventions

Epirubicin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Veronique D'Hondt, MD, PhD

    Jules Bordet Institute

    PRINCIPAL INVESTIGATOR

  • Martine Piccart, MD, PhD

    Jules Bordet Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 13, 2005

Study Start

January 1, 2003

Primary Completion

December 1, 2008

Study Completion

April 1, 2009

Last Updated

July 18, 2008

Record last verified: 2008-07

Locations

BE(1)