E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
proven invasive adenocarcinoma of the breast |
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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 |
The primary objective is to assess differences in endogenous hypoxia markers (CA9, PAI-1, VEGF [Rademakers et al. 2008]) and autophagy (LC3b [Rouschop et al. 2010]) before and after treatment with HCQ. These parameters will be quantified by immunohistochemistry on formalin fixed paraffin embedded tissue from both pretreatment biopsy, and posttreatment surgically obtained material |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives will be to assess differences in putative crucial mediators in the autophagy pathway currently under investigation, i.e. TRB3, ATF4, GRP78, LAMP3, etc |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Patients with core-biopsy proven invasive adenocarcinoma of the breast •Any tumor with a size ≥ 1cm (NOT inflammatory breast cancer) •WHO-performance score 0 or 1 •Written informed consent
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E.4 | Principal exclusion criteria |
•Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol •Hampered liver or kidney function •Serious gastro-intestinal disease •Neurological disease (including epilepsy) •Hematological disease •Psoriasis •Porphyry •G6PD deficiency •Hypersensitivity for quinine •Use of gold containing drugs, oxyfenbutazone, fenylbutazone, digoxin •Operation for breast cancer foreseen within 14 days after inclusion in the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective is to assess differences in endogenous hypoxia markers (CA9, PAI-1, VEGF [Rademakers et al. 2008]) and autophagy (LC3b [Rouschop et al. 2010]) before and after treatment with HCQ. These parameters will be quantified by immunohistochemistry on formalin fixed paraffin embedded tissue from both pretreatment biopsy, and posttreatment surgically obtained material |
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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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.5 | 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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |