patients with metastacic breast cancer disease and anemia
Conditions
Interventions
Trade Name: NeoRecormon
Product Name: NeoRecormon
Pharmaceutical Form: Solution for injection
INN or Proposed INN: epoetin beta
Concentration unit: IU international unit(s)
Concentration type: equal
C
Sponsors
UAB "Roche Lietuva"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Form of informed individual consent signed prior to applying any specific trial selection procedure 2. Patients willing and capable to follow the requirements indicated in the protocol 3. Patients older than 18 years 4. Histologically confirmed metastatic breast carcinoma 5. Patients having no contraindications against capecitabine/docetaxsel treatment 6. Hb = 110g/l 7. Grade according to ECOG Performance Status: 0-2 8. Estimated term of life = 6 months 9. Agreement of pre-menopausal patients to use contraceptives during the trial terms Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Other malignant tumours during the last 5 years (other than completely treated basal cells and (or) squamous cell skin carcinoma (or) squamous cell skin carcinoma and (or) cervical in situ carcinoma) 2. Pregnancy (positive serum pregnancy test) and breast feeding 3. Earlier or detected during inspection disease of CNS (e.g., primary brain tumour, seizures not controllable by standard drug medication, any brain metastases) 4. Clinically significant heart disease, not controllable by drug medication: 4.1. Heart insufficiency, symptomatic coronary heart disease or heart arrhythmia (NYHA class 3 or 4, see. Appendix III) 4.2. Myocardial infarction during the last 12 months 4.3. Treatment resistant hypertension 5. Peripheral neuropathy = 1 grade 6. Transfusion of erythrocyte mass during the last month prior to involvement into clinical trial 7. Anaemia not related directly to chemotherapy and (or) tumour itself 7.1. Iron deficiency anaemia (Fe 105 fL and/or vitamin B12 concentration 105 fL and/or folic acid concentration ULN and indirect bilirubine >ULN ± LDH > ULN) 8. Any laboratory indication value as given below: 8.1. General blood test: number of neutrophils 1,5 x upper norm limit (ULN), ASAT, ALT > 2,5 x ULN, alkaline phosphatase > 2,5 x ULN, serum creatinine > 1,5 x ULN or creatinine clearance = 50 ml/min (calculated according to Cockroft and Gault formula or formula presented in the internet web page: http://www.globalrph.com/crcl.htm) 9. Present or recent (28 days prior to randomisation) uptake of another trial drug or participation in another clinical trial 10. Thrombophylia detected by anamnesis and/or clinically confirmed deep venous thrombosis 11. Acute or chronic bleeding requiring treatment during the last month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to compare response to treatment and time to disease progression in patients with metastatic breast cancer, which have detected Hb levels =110g/l and are treated with capecetabine/docetaxel with or without epoetin beta.;Secondary Objective: ;Primary end point(s): - objective response to treatment, based on tumor evaluation by criteria. Response to treatment is considered like partial remission (PR), complete remission, stable disease (SD), progressive disease (PD); - time to disease progression | — |
Countries
Lithuania
Outcome results
None listed