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.
Conditions
Interventions
Trade Name: Ferinject
Product Name: Ferinject
Product Code: 1-27299
Pharmaceutical Form: Concentrate and solvent for solution for infusion
CAS Number: 0009007-72-1
Concentration unit: mg milligram(s)
Sponsors
Medizinische Universität Wien - Universitätsklinik für Frauenheilkunde
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate treatment efficacy of Darbepoetin alfa and Ferric(III)-Carboxymaltose in comparison to Ferric(III)-Carboxymaltose and Darbepoetin alfa alone in patients with chemotherapy-induced anemia, when given at the last chemotherapy cycle.;Secondary Objective: To assess safety and tolerability of Darbepoetin alfa and Ferric(III)-Carboxymaltose in comparison to Ferric(III)-Carboxymaltose and Darbepoetin alfa alone in patients with chemotherapy-induced anemia, when given at the last chemotherapy cycle. To assess the effect of Darbepoetin alfa and Ferric(III)-Carboxymaltose in comparison to Ferric(III)-Carboxymaltose and Darbepoetin alfa alone in patients with chemotherapy-induced anemia, when given at the last chemotherapy cycle. To assess the incidence of transfusions in patients receiving a combination of Darbepoetin alfa and Ferric(III)-Carboxymaltose in comparison to Ferric(III)-Carboxymaltose and Darbepoetin alfa alone in patients with chemotherapy-induced anemia, when given at the last chemotherapy cycle. ;Primary end point(s): Subjects achieving the target Hb level =11g/dl or an Hb increase of =2g/dl.;Timepoint(s) of evaluation of this end point: end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Proportion of subjects receiving transfusions in 6 weeks after study drug administration • Fatigue and QoL as measured by QLQ-C30 and QLQ-BR23 • Overall 6-month survival ;Timepoint(s) of evaluation of this end point: end of study | — |
Countries
Austria
Contacts
Public ContactAbeitlung für Gynäkologie - Senolog
Medizinische Universität Wien - Universitätsklinik für Frauenheilkunde
Outcome results
None listed