early HER-2 breast cancer
Conditions
Interventions
Product Name: Xeloda
Product Code: RO 09-1978
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Capecitabine
Current Sponsor code: RO 09-1978
Concentration unit: mg milligram(s)
Concentrati
Sponsors
AUSTRIAN BREAST CANCER STUDY GROUP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female patients with histologic proven, core-biopsied, invasive breast cancer of any clinical and/or radiological T-stage (except T4d =inflammatory breast cancer) scheduled to receive preoperative chemotherapy. Patients with bilateral breast cancer can take part in the study if both tumours are histological proven. 2. Age 18-70 years 3. WHO performance-status =65 years) yes F.1.3.1 Number of subjects for this age range 536
Exclusion criteria
Exclusion criteria: 1. Stage T4d/ inflammatory breast cancer 2. Pregnant, or lactating patients; patients of childbearing potential must implement adequate contraceptive measures during study participation except hormonal methods incl. oral contraceptives, 3-month Depo-Provera shots, monthly injections, implants, contraceptive patches 3. Pre-existing motor or sensory neurotoxicity of a severity > grade 2 by WHO criteria 4. Preoperative local treatment for breast cancer (i.e. incomplete surgery, radiotherapy) 5. Prior or concurrent systemic antitumor therapy 6. Other serious illness or medical condition (a) congestive heart failure or unstable angina pectoris even if it is medically controlled. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high risk uncontrolled arrythmias (b) history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent (c) active uncontrolled infection. (d) unstable peptic ulcer, unstable diabetes mellitus or other contraindication for the use of corticosteroids 7. Concurrent treatment with corticosteroids except as use for the prophylactic medication 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) 8. Known hypersensitivity against taxanes and/or Epirubicin and/or Fluorouracil/Capecitabine and/or trastuzumab. 9. Known deficit of dihydropyrimidine-dehydrogenase (DPD) 10. Treatment with an investigational drug within 30 days prior to study entry. 11. Legally incapacitated and/or other circumstances which make it undesirable for the subject to understand the nature, meaning and consequences of the clinical study. 12. Concurrent psychiatric illness according to ICD (alcohol addiction) at the time of study entry. 13. Patients with New Yourk Heart Association (NYHA) class = II heart disease. 14. HER-2 positive Patients with a left ventricular ejection fraction (LVEF) of <55% by echocardiography or Muga Scan. 15. Serious uncontrolled infections (bacterial odr viral) or poorly controlled diabetes mellitus. 16. Positive infraclavicular or supraclavicular lymph node.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Rate (percentage) of pathological complete remissions at the time of final surgery after 6 cycles in Arm A (Epirubicin/Docetaxel/Capecitabine-containing chemotherapy) vs. Arm B (Epirubicin/Docetaxel/-containing chemotherapy) ;Secondary Objective: Rate (percentage) of axillary lymph node involvement at the time of final surgery in Arm A vs. Arm B. Rate (percentage) of breast-conserving procedures at the time of final surgery in Arm A vs. Arm B. ;Primary end point(s): Rate of pathological complete remissions in Arm A (Epirubicin/Docetaxel/Capecitabine-containing chemotherapy) vs. Arm B (Epirubicin/Docetaxel/-containing chemotherapy) ;Timepoint(s) of evaluation of this end point: at the time of final surgery after 6 cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Rate of axillary lymph node involvement of Arm A (± trastuzumab in HER-2 positive disease) vs. Arm B (± trastuzumab in HER-2 positive disease).;Timepoint(s) of evaluation of this end point: at the time of final surgery after 6 cycles | — |
Countries
Austria
Contacts
Public ContactTrial Office
ABCSG
Outcome results
None listed