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Randomized Neoadjuvant Study of Epirubicin and Docetaxel With/Without Capecitabine in Early Breast Cancer

Information source: Austrian Breast & Colorectal Cancer Study Group
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Early-Stage Breast Cancer

Intervention: Epirubicin (Drug); Docetaxel (Drug); Capecitabine (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Austrian Breast & Colorectal Cancer Study Group

Official(s) and/or principal investigator(s):
Guenther Steger, MD, Principal Investigator, Affiliation: Austrian Breast & Colorectal Cancer Study Group

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Rates of pathologic complete remissions

Secondary outcome: Rates of axillary lymph node involvement and breast-conserving procedures

Eligibility

Minimum age: 19 Years. Maximum age: 80 Years. Gender(s): Female.

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

Locations and Contacts

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

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

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

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

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

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

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

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

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

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 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

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

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

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

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

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
Sabine Poestlberger, MD, Phone: +43-732-7677, Ext: 7300, Email: sabine.poestlberger@bhs.at
Sabine Poestlberger, 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

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

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

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

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

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

Additional Information

Starting date: February 2005
Last updated: March 31, 2006

Page last updated: December 08, 2011

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