De Optimal studie:Optimaliseren van Everolimus behandeling door het splitsen van innamemomenten.
- Conditions
- Advanced hormone positive, HER2 negative, breast cancer.
- Registration Number
- NL-OMON21051
- Lead Sponsor
- etherlands Cancer Intitute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
1.Age >18 years;
2.Able and willing to give written informed consent;
Exclusion Criteria
1.Woman who are pregnant or breast feeding;
2.Known hypersensitivity to any of the study drugs or excipients;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics of 10 mg QD vs 5 mg BID Everolimus: evaluated PK parameters will be a.o. Cmax/Cmin ratio, AUC,<br>Cmax, Cmin, Tmax.
- Secondary Outcome Measures
Name Time Method Incidence and severity of stomatitis and other adverse events between the two dosing schedules, according to CTC-AE<br>v4.03.