E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Breast cancer |
mammacarcinoom |
|
E.1.1.1 | Medical condition in easily understood language |
Breast cancer |
Borstkanker |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10070575 |
E.1.2 | Term | Estrogen receptor positive breast cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
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 determine the influence of morning versus evening administration on the pharmacokinetics of tamoxifen and its metabolites. |
Bepalen van de invloed van inname in de ochtend versus inname in de avond op de farmacokinetiek van tamoxifen en de metabolieten |
|
E.2.2 | Secondary objectives of the trial |
To determine differences in adverse effects between morning and evening administration of tamoxifen. |
Bepalen van verschillen in bijwerkingen tamoxifen tussen inname in de ochtend en avond |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Histological or cytological confirmed diagnosis of breast cancer, for which treatment with tamoxifen is indicated (to be evaluated by the treating physician);
-Use of tamoxifen for at least 4 weeks and willing to continue the treatment until the end of the study;
-Age > 18 years;
-WHO performance ≤ 1;
-Written informed consent;
-Adequate renal and hepatic functions;
-Adequate hematological blood counts;
-No chemotherapy within the last 4 weeks before start;
-No radiotherapy within the last 4 weeks before start.
|
-Histologisch bewezen diagnose van borstkanker, waarvoor behandeling met tamoxifen is geindiceerd (bepaald door behandelend arts);
-Gebruik van tamoxifen voor tenminste 4 weken en de intentie tot het continueren van de therapie tot het einde van de studie;
-Leeftijd > 18 jaar;
-WHO performance ≤ 1;
-Written informed consent;
-Adequate renale en hepatische functies;
-Adequate hematologische bloedwaarden;
-Geen chemotherapie in de afgelopen 4 weken voor de start van de studie;
-Geen radiotherapie in de afgelopen 4 weken voor de start van de studie.
|
|
E.4 | Principal exclusion criteria |
-Pregnant or lactating patients;
-Serious illness or medical unstable condition requiring treatment, symptomatic CNS metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent;
-More than one dose of tamoxifen (20 or 40 mg) per day;
-Non-compliance.
|
-Zwangere, lacterende patiënten;
-Ernstige ziekte of een medisch instabiele conditie waarvoor behandeling noodzakelijk is, symptomatische CZS-metastasen of een geschiedenis van psychiatrische stoornissen wat zorgt voor het niet kunnen begrijpen van de informatie en waardoor informed consent niet mogelijk is;
-Meer dan één dosering van tamoxifen per dag (20 of 40 mg);
-Therapieontrouw.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
-Determine differences in tamoxifen pharmacokinetics during tamoxifen administration in the morning compared to administration in the evening. |
-Bepalen van verschillen in tamoxifen farmacokinetiek tijdens inname in de ochtend vergeleken met inname in de avond |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
-Determine differences in adverse effects during tamoxifen administration in the morning compared to administration in the evening. |
- Bepalen van verschillen in tamoxifen bijwerkingen tijdens inname in de ochtend vergeleken met inname in de avond. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
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 | Yes |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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
|
18 patients will be included and analysis will be performed on 18 patients |
18 patienten zullen geincludeerd en geanalyseerd worden |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
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 |