The OPTIMAL study: Optimizing Performance of afiniTor by splitting Intake Moments and decreasing Adverse events whilst maintaining outcome quaLity.

Recruiting

Conditions: Breast Cancer
HER-2 negative
Hormone Positieve
10006291

Registration Number: NL-OMON41877

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

1.Age >= 18 years;
2.Able and willing to give written informed consent;
3.Able and willing to undergo blood sampling for PK analysis;
4.Histopathologically confirmed advanced hormone positive, HER2 negative, breast cancer for which everolimus in combination with exemestane is considered standard of care.
5.Minimal acceptable safety laboratory values
a.ANC of >= 1.5 x 10^9 /L
b.Platelet count of >= 100 x 10^9 /L
c.Hepatic function as defined by serum bilirubin <= 1.5 x ULN, ASAT and ALAT <=2.5 x ULN
d.Renal function as defined by serum creatinine <= 1.5 x ULN or creatinine clearance >= 50 mL/min (by Cockcroft-Gault formula);

Exclusion Criteria

1.Woman who are pregnant or breast feeding;
2.Known hypersensitivity to any of the study drugs or excipients;
3.Unable or unwilling to undergo pharmacokinetic sampling;
4.Use of any concomitant medication (including OTC and herbal medication) which may induce or inhibit function of CYP3A4, including but not limited to efavirenz, etravirine, nevirapine, rifampicine, boceprevir, claritromycine, elvitegravir, erytromycine, fluconazol, itraconazol, ketoconazol, posaconazol, telaprevir, verapamil, cyclosporine, voriconazol, dexamethason, St John*s Wort and grapefruit juice;
5.Patients with known alcoholism, drug addiction and/or psychiatric of physiological condition which in the opinion of the investigator would impair study compliance;
6.Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications;
7.Legal incapacity

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetics of 10 mg QD vs 5 mg BID Everolimus: evaluated PK parameters<br /><br>will be a.o. Cmax/Cmin ratio, AUC, Cmax, Cmin, Tmax.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Incidence and severity of stomatitis and other adverse events between the two<br /><br>dosing schedules, according to CTC-AE v4.03.<br /><br>Exploratory objective: Quantifying Everolimus in the oral fluid of patients.</p><br>