NCT00162812

TerminatedPhase 2

Topoisomerase II Alpha Gene Amplification and Protein Overex...

Jules Bordet Institute Source

Jules Bordet Institute

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

TOP Trial

Secondary identifiers

CE1141

Study Type

interventional

Estimated enrollment

338

Locations

1 country

Sites

1

Timeline

Study Start

January 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2008

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

April 2009

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Estimated enrollment: 338 participants
Study completion date: April 2009
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2003
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 9, 2005
Actual (reported)
First Posted
September 13, 2005
Actual (reported)
Primary Completion
December 2008
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2009
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: July 18, 2008
Status Verified: July 2008
Last Update Submitted: 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)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Sponsors & Collaborators

Clinique Louis Cathy - Baudour - Belgium
Type not reportedcollaborator
HIS - Site Etterbeek - Ixelles - Belgium
Type not reportedcollaborator

Study Sites (1)

Jules Bordet Institute

Brussels, 1000, Belgium

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 Hydrocarbons

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 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2008

Estimated (date passed)

NCT00193206

Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer

Phase 2Completed

NCT04224922

Phase II Study of Neoadjuvant Weekly Paclitaxel and Carboplatin Followed by Dose Dense Epirubicin and Cyclophosphamide in Stage II and III Triple Negative Breast Cancer

Phase 2Completed

NCT00199134

FRAGRANCE Part A Safety: Study to Find a Genetic Signature of de Novo Resistance to Letrozole

Phase 2Completed

NCT02846428

To Evaluate the Efficacy and Safety of Capecitabine Prior to Surgery in Women With Breast Cancer

Phase 2Completed

NCT00066339

Gefitinib in Treating Patients With Metastatic Breast Cancer That Has Progressed After Antiestrogen and Nonsteroidal Aromatase Inhibitor Therapy

Phase 2Completed

NCT00253500

Epirubicin in Treating Women Who Are Undergoing Surgery for Stage I, Stage II, or Stage III Breast Cancer

Phase 2Completed

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.

Clinique Ste Elisabeth - Namur - Belgium

Type not reportedcollaborator

Centre Paul Strauss

Othercollaborator

Clinique Saint Pierre Ottignies

Othercollaborator

Jules Bordet Institute

Otherlead

University Hospital of Crete

Othercollaborator

Centre Hospitalier du Luxembourg

Othercollaborator

Feculdade de Medicina da Universidade de Sao Paulo - Brasil

Othercollaborator

Gustave Roussy, Cancer Campus, Grand Paris

Othercollaborator

Hydrocarbons, Aromatic

Hydrocarbons, Cyclic

Hydrocarbons

Organic Chemicals

Polycyclic Compounds

Aminoglycosides

Glycosides

Carbohydrates

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

April 2009

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

July 18, 2008

Record last verified: 2008-07

Source record

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Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00162812
Data provider: ClinicalTrials.gov
Source updated: 2008-07-18
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:31:19 UTC

Locations

BE(1)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations