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