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| 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 |
Eligibility| Ages Eligible for Study: | 19 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Results of the following assessments at the time of randomization must be available:
Exclusion Criteria:
Other serious illness or medical condition
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
Contacts and 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 | |
| Principal Investigator: | Guenther Steger, MD | Austrian Breast & Colorectal Cancer Study Group |
More Information
| 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 |
|
Epirubicin Docetaxel Capecitabine Breast cancer |
|
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 |