E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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E.1.1.1 | Medical condition in easily understood language |
patients with breast cancer and chemotherapy induced anemia |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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%
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Subjects achieving the target Hb level ≥11g/dl or an Hb increase of ≥2g/dl. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
The combination of FCM and Aranesp |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |