Prospective controlled clinical trial of metastatic breast cancer treatment with capecitabine/docetaxel in combination with beta epoetin as compared with sole capecitabine/docetaxel treatment

• Conditions: patients with metastacic breast cancer disease and anemia

• Registration Number: EUCTR2006-000137-35-LT
• Lead Sponsor: AB Roche Lietuva

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 60

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

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 < LLN or feritine <10 µg/l), which can not be corrected with iron supplements
7.2. Vitamin B12 deficiency anaemia (MCV >105 fL and/or vitamin B12 concentration < LLN), which can not be corrected with vitamin B12
7.3. Folic acid deficiency anaemia (MCV >105 fL and/or folic acid concentration < LLN), which can not be corrected with folic acid preparations
7.4. Haemolytic anaemia (laboratory indications of haemolysis: reticulocytes > 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 109/l, number of thrombocites < 50 x 109/l,
8.2. Biochemical blood test: total bilirubine > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified