A prospective, randomized, multicenter study to evaluate the impact of Darbepoetin alfa in combination with Ferric(III)-Carboxymaltose in comparison to Darbepoetin alfa and Ferric(III)-Carboxymaltose alone in patients with breast cancer and chemotherapy-induced anemia - CIA-Study

Conditions: This is a prospective, multicenter, randomized, comparative, parallel group, phase IV study to assess the efficacy and safety of FCM 800mg or Darbepoetin alfa 500µg or the combination of FCM 800mg and Darbepoetin alfa 500µg within 24h last chemotherapy administration in patients with breast cancer and chemotherapy induced anemia.
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-001664-22-AT

Lead Sponsor: Medizinische Universität Wien - Universitätsklinik für Frauenheilkunde

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 75

Inclusion Criteria

•Signed informed consent prior to study specific procedures
•Female sex, 18 years of age or older at the time the written informed consent is obtained.
•Negative pregnancy test (serum or urine human chorionic gonadotropin (hCG) from women with childbearing age at screening.
•Subjects must have a confirmed adenocarcinoma of the breast and receive neoadjuvant or adjuvant multicycle chemotherapy.
•Subjects must have Haemoglobin levels ranging from 8-10g/dl prior to last chemotherapy.
•Subjects must have iron levels of ferritin =800ng/mL and transferrin saturation <20%

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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

•Haemoglobin levels =7,9g/dl or =10,1g/dl
•Subjects with absolute iron deficiency, defined as ferritin <30 ng/mL and transferrin saturation < 15%.
•Subjects with known haemoglobinopathy or haemochromatose.
•History of arterial or venous thrombosis, including transient ischemic attack (TIA), within 1 year prior to randomization.
•Active infection.
•Known human immunodeficiency virus (HIV), hepatitis C, or hepatitis B infection.
•Uncontrolled hypertension as defined a systolic blood pressure = 150 mmHg and diastolic pressure = 90mmHg. Anti-hypertensive medications are allowed if the subject is stable on their dose at the time of randomization.
•Known hypersensitivity to FCM or to any other iron preparation.
•Any condition which in the investigator’s opinion makes the subject unsuitable for study participation.
•Pregnant (ie, positive beta-human chorionic gonadotropin test) or breast feeding.
•Use of recombinant human erythropoietins 3 weeks prior to screening.
•Known hypo- or hyperthyroidism
•Intake of i.v. or oral iron preparation within 4 weeks prior to screening.
•Subject previously has entered this study.
•Inability to comply with protocol and/or not available for follow-up assessments.