Status:
COMPLETED
Randomized Neoadjuvant Study of Epirubicin and Docetaxel With/Without Capecitabine in Early Breast Cancer
Lead Sponsor:
Austrian Breast & Colorectal Cancer Study Group
Collaborating Sponsors:
Amgen
Ebewe Pharma GmbH
Conditions:
Breast Cancer
Eligibility:
FEMALE
19-80 years
Phase:
PHASE3
Brief 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 + ca...
Detailed Description
This study is a prospective, randomized, multicentre, phase III trial in the neoadjuvant treatment of patients with primary breast cancer and no distant metastases. Patients will be stratified at incl...
Eligibility Criteria
Inclusion
- 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:
- chest wall CT, abdomen CT, bilateral mammography: within 4 weeks before enrolment;
- laboratory requirements: within 2 weeks before enrolment
- hematology: neutrophils ≥ 4.0 x 109/l, platelets ≥ 150 x 109/l, haemoglobin ≥ 13 g/dl
- 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.
- renal function: creatinine ≤ 1 x ULN,
- 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
- 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
- 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
- history of significant neurologic or psychiatric disorders, including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent
- active uncontrolled infection
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
536 Patients enrolled
Trial Details
Trial ID
NCT00309556
Start Date
February 1 2005
End Date
November 1 2011
Last Update
December 30 2011
Active Locations (26)
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1
Hospital Guessing
Güssing, Burgenland, Austria, 7540
2
Hospital Oberpullendorf
Oberpullendorf, Burgenland, Austria, 7350
3
Hospital Oberwart
Oberwart, Burgenland, Austria, 7400
4
State Hospital Klagenfurt
Klagenfurt, Carinthia, Austria, 9026