E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Kvinder, som har modtaget definitiv kirurgi for histologisk verificeret operabel ikke-metastatisk HER2-positiv brystkræft stratificeret i gruppen med øget risiko i hht. DBCG´s retningslinier, og som har modtaget mindst fire serier adjuverende kemoterapi.
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10006204 |
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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 |
Forsøgets formål er at introducere adjuverende behandling med trastuzumab til danske patienter med tidlig HER2-positiv operabel brystkræft på populationsbaseret basis med monitorering af kli-nisk status samt kardiologisk toksicitet. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Kvinde 2. Alder > 17 år, < 69 år 3. Performancestatus < 2 4. Ikke-metastatisk operabelt histologisk konfirmeret primært adenokarcinom i brystet opereret radikalt helst i.h.t. DBCG´s retningslinier 5. Node+ eller højrisiko node- i.h.t. DBCG´s retningslinier 6. Afsluttet behandling omfattende mindst fire serier præoperativ og/eller postoperativ adjuve-rende kemoterapi 7. Afsluttet eventuel adjuverende radioterapi 8. Normal hjertefunktion ( LVEF55% ved ekkokardiografi eller MUGA-skanning) bestemt ef-ter afsluttet præoperativ og/eller adjuverende kemoterapi. Såfremt LVEF er nedsat (med < 5% point) kan ny bestemmelse eventuelt foretages 1-2 måneder senere 9. Overekspression af HER2 i den invasive komponent af primær tumor. HER2-status be-stemmes på primærtumor ved immunohistokemi og/eller FISH. HER2-positiv status er im-munohistokemisk score 3+ og/eller FISH-positiv. HER2-bestemmelse foretages efter lokale retningslinier, men med kvalitetskontrol monitoreret af Patologiudvalget i DBCG. 10. Mundtligt og skriftligt informeret samtykke fra patienten
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E.4 | Principal exclusion criteria |
1. Samtidig eller tidligere anden malign sygdom (eksklusiv cancer mammae) indenfor de se-neste 5 år 2. Modtaget kumulativ dosis af doxorubicin>360 mg/m2 eller epirubicin>720 mg/m2 3. Tidligere strålebehandling omfattende mediastinum bortset fra eventuel strålebehandling af mammaria interna-lymfeknuder som led i adjuverende strålebehandling 4. Alvorlige medicinske tilstande, herunder hjertesygdomme, så som a. aktuel eller tidligere dokumenteret kongestiv hjerteinsufficiens b. højrisiko ukontrolleret hjertearrytmi c. behandlingskrævende angina pectoris d. klinisk betydende hjerteklapsygdom e. EKG-verificeret transmuralt myokardieinfarkt f. dårligt kontrolleret arteriel hypertension g. andre konkurrerende alvorlige syfdomme, som kan interfere med behandlingen, herunder iltkrævende eller svær dyspnoe 5. Kendt hypersensitivitet over for trastuzumab eller for murine proteiner 6. Gravid eller lakterende kvinde
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E.5 End points |
E.5.1 | Primary end point(s) |
Primære: Hyppighed af og beskrivelse af omfang og forløb af tilfælde af symptomatisk hjertesygdom |
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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 | No |
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 | Information not present in EudraCT |
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 | No |
E.8.1.1 | Randomised | No |
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) | No |
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.8.5 | 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 | Information not present in EudraCT |
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 | 6 |
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 | 6 |