E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Breast cancer high risk stage II, III or IV according to AJCC classification |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006200 |
E.1.2 | Term | Breast cancer stage II |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006201 |
E.1.2 | Term | Breast cancer stage III |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006202 |
E.1.2 | Term | Breast cancer stage IV |
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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 |
Demonstration of non-inferiority of XM22 versus pegfilgrastim (Neulasta® – Amgen) in patients with breast cancer during the first cycle of chemotherapy with respect to the duration of severe neutropenia (DSN). |
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E.2.2 | Secondary objectives of the trial |
1. Demonstration of efficacy and safety of XM22 in comparison to pegfilgrastim in patients with breast cancer under chemotherapy based on the secondary efficacy and safety endpoints. 2. Evaluation of pharmacokinetic properties of XM22 in comparison to pegfilgrastim. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
1. PK substudy 2. Substudy for CD34+ cells mobilization properties of XM22 |
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E.3 | Principal inclusion criteria |
• Written informed consent. • Men and women aged ≥18 years. • The patient must be able to understand and follow instructions and must be able to participate in the study for the entire period. • Breast cancer high risk stage II, III or IV according to American Joint Committee on Cancer (AJCC) classification • Patients planned and eligible to receive 4 cycles of treatment with docetaxel/doxorubicin as routine chemotherapy for their breast cancer disease. • Chemotherapy naive. • Eastern Cooperative Oncology Group (ECOG) performance status ≤2. • ANC ≥1.5 x 10(9)/L. • Platelet count ≥100 x 10(9)/L. • Adequate cardiac function (including left ventricular ejection fraction ≥50% as assessed by echocardiography or equivalent method within 4 weeks prior to randomisation). • Adequate hepatic function, i.e. alanine and aspartate aminotransferases (ALT and AST) <2.5 x upper limit of normal (ULN), alkaline phosphatase <5 x ULN, bilirubin <ULN. • Adequate renal function, i.e. creatinine <1.5 x ULN. |
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E.4 | Principal exclusion criteria |
• Participation in a clinical trial within 30 days before randomisation. • Previous exposure to filgrastim, pegfilgrastim or lenograstim or other G-CSFs in clinical development less than 6 months before randomisation. • Known hypersensitivity to docetaxel or doxorubicin, filgrastim, pegfilgrastim or lenograstim. • Underlying neuropathy of grade 2 or higher. • Treatment with systemically active antibiotics within 72 hours before chemotherapy. • Treatment with lithium at inclusion or planned during the entire study. • Chronic use of oral corticosteroids. • Prior radiation therapy or tumour surgery within 4 weeks before randomisation. • Prior bone marrow or stem cell transplantation. • Prior malignancy within the previous 5 years other than basal cell or squamous cell carcinomas or in situ carcinoma of the cervix. • Any illness or condition that in the opinion of the investigator may affect the safety of the patient or the evaluation of any study endpoint. • Pregnant or nursing women. Women of child-bearing potential who do not agree to use a highly effective method of birth control during the entire duration of the study |
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E.5 End points |
E.5.1 | Primary end point(s) |
DSN in cycle 1, defined as grade 4 neutropenia with an ANC <0.5 x 10(9)/L.
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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The study will end when the last patient has completed his/her last visit (last antibody assessment on day 360) |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |