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Randomized Neoadjuvant Study of Epirubicin and Docetaxel With/Without Capecitabine in Early Breast Cancer
This study is currently recruiting participants.
Verified by Austrian Breast & Colorectal Cancer Study Group, February 2006
First Received: March 31, 2006   No Changes Posted
Sponsor: Austrian Breast & Colorectal Cancer Study Group
Information provided by: Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier: NCT00309556
  Purpose

Primarily, this clinical investigation compares the rates (percentages) of pathological complete remissions attained at the time of final surgery following 6 cycles each of epirubicin + docetaxel + capecitabine-containing chemotherapy vs. epirubicin + docetaxel-containing chemotherapy.


Condition Intervention Phase
Early-Stage Breast Cancer
Drug: Epirubicin
Drug: Docetaxel
Drug: Capecitabine
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title: A Randomized Phase III Study Comparing Epirubicin, Docetaxel and Capecitabine + G-CSF Vs. Epirubicin and Docetaxel + G-CSF as Neoadjuvant Treatment for Early Breast Cancer

Resource links provided by NLM:


Further study details as provided by Austrian Breast & Colorectal Cancer Study Group:

Primary Outcome Measures:
  • Rates of pathologic complete remissions

Secondary Outcome Measures:
  • Rates of axillary lymph node involvement and breast-conserving procedures

Estimated Enrollment: 460
Study Start Date: February 2005
  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients with histologically proven, core-biopsied, invasive breast cancer of any clinical and/or radiological T-stage (except for T4d)
  • Age 18-70 years
  • WHO performance status ≤ 2
  • No prior or current neoplasm except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix
  • No distant disease / secondary carcinoma judged clinically and at least by chest X-ray, liver sonography, and bone scan upon randomization
  • No medical and/or cardiologic contraindication to receive an anthracycline- and taxane-containing chemotherapy regimen. Normal cardiac function must be confirmed by LVEF (echocardiography or Muga scan). The result must be above 50% or above the institution’s ULN
  • Results of the following assessments at the time of randomization must be available:

    1. chest wall CT, abdomen CT, bilateral mammography: within 4 weeks before enrolment;
    2. laboratory requirements: within 2 weeks before enrolment
    3. hematology: neutrophils ≥ 4.0 x 109/l, platelets ≥ 150 x 109/l, haemoglobin ≥ 13 g/dl
    4. hepatic function: total bilirubin < 1 x ULN, ASAT (SGOT) and ALAT (SGPT) < 1x ULN, alkaline phosphatase < 1 x ULN. In case of abnormal values, liver function tests have to be repeated within 3 days before study treatment.
    5. renal function: creatinine ≤ 1 x ULN,
    6. histology, grading, hormone receptor status, HER-2/neu status
  • Signed and dated informed consent before the start of specific protocol procedures
  • Negative pregnancy test in the presence of childbearing potential

Exclusion Criteria:

  • Stage T4d / inflammatory breast cancer
  • Pregnant or lactating patients; patients of childbearing potential must implement adequate contraceptive measures during study participation
  • Pre-existing motor or sensory neurotoxicity of a severity ≥ WHO grade 2
  • Preoperative local treatment for breast cancer (i.e. incomplete surgery, radiotherapy)
  • Prior or concomitant systemic antitumor therapy
  • Other serious illness or medical condition

    1. congestive heart failure or unstable angina pectoris, even if medically controlled.

      Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrythmias

    2. history of significant neurologic or psychiatric disorders, including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent
    3. active uncontrolled infection
    4. unstable peptic ulcer, unstable diabetes mellitus or other contraindication for the use of corticosteroids
  • Concurrent treatment with corticosteroids except as use for the prophylactic regimen, inhalational use, treatment of acute hypersensitivity reactions, treatment of nausea/vomiting or chronic treatment (initiated > 6 months prior to study entry) at low dose (≤ 20 mg methylprednisolone or equivalent)
  • Known hypersensitivity against taxanes and/or epirubicin and/or fluorouracil/capecitabine
  • Known dihydropyrimidine-dehydrogenase (DPD) deficit
  • Treatment with an investigational drug within 30 days prior to study entry
  • Legally incapacitated and/or other circumstances which make it unfeasible for the subject to understand the nature, meaning and consequences of the clinical study
  • Concurrent psychiatric illness according to ICD (alcohol addiction) at the time of study entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309556

Locations
Austria
Paracelsus Medical University Salzburg - Oncology Recruiting
Salzburg, Austria, 5020
Contact: Richard Greil, MD     +43-662-4482 ext 2881     r.greil@salk.at    
Principal Investigator: Richard Greil, MD            
Hanusch Hospital Recruiting
Vienna, Austria, 1140
Contact: Michael Stierer, MD     +43-1-91021 ext 2560     michael.stierer@wgkk.sozvers.at    
Principal Investigator: Michael Stierer, MD            
Medical University Vienna, General Hospital Recruiting
Vienna, Austria, 1090
Contact: Guenther Steger, MD     +43-1-40400 ext 4426     guenther.steger@meduniwien.ac.at    
Principal Investigator: Guenther Steger, MD            
Medical University Vienna, General Hospital Recruiting
Vienna, Austria, 1090
Contact: Ernst Kubista, MD     +43-1-40400 ext 2880     ernst.kubista@meduniwien.ac.at    
Principal Investigator: Ernst Kubista, MD            
State Hospital Vienna-Lainz Recruiting
Vienna, Austria, 1130
Contact: Paul Sevelda, MD     +43-1-80110 ext 2294     paul.sevelda@wienkav.at    
Principal Investigator: Paul Sevelda, MD            
Austria, Burgenland
Hospital Guessing Recruiting
Guessing, Burgenland, Austria, 7540
Contact: Wilfried Horvath, MD     +43-3322-33260     chirurgie.khguessing@krages.at    
Principal Investigator: Wilfried Horvath, MD            
Hospital Oberpullendorf Recruiting
Oberpullendorf, Burgenland, Austria, 7350
Contact: Friedrich Hofbauer, MD     +43-05-7979 ext 34201     Friedrich.Hofbauer@krages.at    
Principal Investigator: Friedrich Hofbauer, MD            
Hospital Oberwart Recruiting
Oberwart, Burgenland, Austria, 7400
Contact: Eduard Klug, MD     +43-3352-400 ext 33405     eue.klug@aon.at    
Principal Investigator: Eduard KLug, MD            
Austria, Carinthia
Hospital BHB St. Veit/Glan, Surgery Recruiting
St. Veit a. d. Glan, Carinthia, Austria, 9330
Contact: Joerg Tschmelitsch, MD     +43-4212-499 ext 495     joerg.tschmelitsch@bbstveit.at    
Principal Investigator: Joerg Tschmelitsch, MD            
Ordination Dr. Wette Recruiting
St. Veit a. d. Glan, Carinthia, Austria, 9300
Contact: Viktor Wette, MD     +43-4212-33222     wetteviktor@aon.at    
Principal Investigator: Viktor Wette, MD            
State Hospital Klagenfurt Recruiting
Klagenfurt, Carinthia, Austria, 9026
Contact: Ernst-Pius Forsthuber, MD     +43 463 538 ext 39610     ernst.forsthuber@lkh-klu.at    
Principal Investigator: Ernst-Pius Forsthuber, MD            
State Hospital Wolfsberg Recruiting
Wolfsberg, Carinthia, Austria, 9400
Contact: Elisabeth Melbinger-Zeinitzer, MD     +43-4352-533 ext 240     elisabeth.melbinger-zeinitzer@lkh-wo.at    
Principal Investigator: Elisabeth Melbinger-Zeinitzer, MD            
State Hospital Villach Recruiting
Villach, Carinthia, Austria, 9500
Contact: Georg Erich Keckstein, MD     +43-4242-208 ext 2547     joerg.keckstein@lkh-vil.or.at    
Principal Investigator: Georg Erich Keckstein, MD            
Austria, Lower Austria
Hospital Baden Recruiting
Baden bei Wien, Lower Austria, Austria, 2500
Contact: Harald Trapl, MD     +43-2252-205     harald.trapl@baden.lknoe.at    
Principal Investigator: Harald Trapl, MD            
Hospital Krems Recruiting
Krems, Lower Austria, Austria, 3500
Contact: Klaus Toegel, MD     +43-2732-804 ext 528     k.toegel@gmx.at    
Principal Investigator: Klaus Toegel, MD            
Hospital of Wiener Neustadt Recruiting
Wiener Neustadt, Lower Austria, Austria, 2700
Contact: Werner Kwasny, MD     +43-2622-23521 ext 0     werner.kwasny@chello.at    
Principal Investigator: Werner Kwasny, MD            
Hospital St. Poelten Recruiting
St. Poelten, Lower Austria, Austria, 3100
Contact: Peter Balcke, MD     +43-2742-300 ext 2971     prof.balcke@kh-st-poelten.at    
Principal Investigator: Peter Balcke, MD            
Austria, Styria
Gynaegological Medical University Graz Recruiting
Graz, Styria, Austria, 8036
Contact: Gero Luschin-Ebengreuth, MD     +43-316-385 ext 83698     gero.luschin@meduni-graz.at    
Principal Investigator: Gero Luschin-Ebengreuth, MD            
Medical University of Graz, Oncology Recruiting
Graz, Styria, Austria, 8036
Contact: Hellmut Samonigg, MD     +43-316-385 ext 3112     hellmut.samonigg@klinikum-graz.at    
Principal Investigator: Hellmut Samonigg, MD            
State Hospital Leoben Recruiting
Leoben, Styria, Austria, 8700
Contact: Felix Keil, MD     +43-3842-401     felix.keil@lkh-leoben.at    
Principal Investigator: Felix Keil, MD            
Austria, Tyrol
Medical University of Innsbruck Recruiting
Innsbruck, Tyrol, Austria, 6020
Contact: Christian Marth, MD     +43-512-504 ext 23050     christian.marth@uibk.ac.at    
Principal Investigator: Christian Marth, MD            
District Hospital Kufstein Recruiting
Kufstein, Tyrol, Austria, 6330
Contact: August Zabernigg, MD     +43-5372-6966     august.zabernigg@bkh-kufstein.at    
Principal Investigator: August Zabernigg, MD            
Austria, Upper Austria
Hospital BHS Linz Recruiting
Linz, Upper Austria, Austria, 4010
Contact: Sabine Poestlberger, MD     +43-732-7677 ext 7300     sabine.poestlberger@bhs.at    
Principal Investigator: Sabine Poestlberger, MD            
Hospital Kreuzschwestern Wels Recruiting
Wels, Upper Austria, Austria, 4600
Contact: Josef Thaler, MD     +43-7242-415 ext 3452     josef.thaler@klinikum-wels.at    
Principal Investigator: Josef Thaler, MD            
Ordination Dr. Tausch Recruiting
Linz, Upper Austria, Austria, 4020
Contact: Christoph Tausch, MD     +43-732-784999     ordination@chirurgie-tausch.at    
Principal Investigator: Christoph Tausch, MD            
State Hospital Steyr Recruiting
Steyr, Upper Austria, Austria, 4400
Contact: Johannes Andel, MD     +43-7252-880 ext 1558     Johannes.andel@gespag.at    
Principal Investigator: Johannes Andel, MD            
State Hospital Kirchdorf Recruiting
Kirchdorf, Upper Austria, Austria, 4560
Contact: Bruno Schneeweiss, MD     +43-7582-696 ext 0        
Principal Investigator: Bruno Schneeweiss, MD            
Hospital BHS Linz Recruiting
Linz, Upper Austria, Austria, 4010
Contact: Andreas Petzer, MD     +43-732-7677     andreas.petzer@bhs.at    
Principal Investigator: Andreas Petzer, MD            
General Hospital Linz Recruiting
Linz, Upper Austria, Austria, 4020
Contact: Michael Fridrik, MD     +43-732-7806 ext 1943     michael.fridrik@akh.linz.at    
Principal Investigator: Michael Fridrik, MD            
Austria, Vorarlberg
State Hospital Feldkirch Recruiting
Feldkirch, Vorarlberg, Austria, 6807
Contact: Alois Lang, MD     +43-5522-303 ext 9231     alois.lang@lkhf.at    
Principal Investigator: Alois Lang, MD            
Sponsors and Collaborators
Austrian Breast & Colorectal Cancer Study Group
Investigators
Principal Investigator: Guenther Steger, MD Austrian Breast & Colorectal Cancer Study Group
  More Information

Additional Information:
No publications provided

Study ID Numbers: ABCSG-24, Ro 09-1978
Study First Received: March 31, 2006
Last Updated: March 31, 2006
ClinicalTrials.gov Identifier: NCT00309556     History of Changes
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Austrian Breast & Colorectal Cancer Study Group:
Epirubicin
Docetaxel
Capecitabine
Breast cancer

Additional relevant MeSH terms:
Antimetabolites
Capecitabine
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Breast Neoplasms
Antibiotics, Antineoplastic
Epirubicin
Pharmacologic Actions
Docetaxel
Neoplasms
Neoplasms by Site
Therapeutic Uses
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010