Advanced hormone positive, HER2 negative, breast cancer.
Conditions
Interventions
5 mg BID Everolimus plus 25 mg QD Exemestane vs 10 mg QD Everolimus plus 25 mg QD Exemestane
Sponsors
Netherlands Cancer Intitute
Eligibility
Inclusion criteria
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 cancer for which everolimus is considered standard of care, who will start with or are already receiving everolimus therapy (breast cancer patients will also receive exemestane (in accordance with the summary of product characteristics), other patients will receive everolimus monotherapy). 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 ¡Ü 1.5 x ULN, ASAT and ALAT ¡Ü2.5 x ULN d.Renal function as defined by serum creatinine ¡Ü1.5 x ULN or creatinine clearance >50 mL/min (by Cockcroft- Gault formula);
Exclusion criteria
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; 8.CT or other tumour response evaluation planned during the 4 weeks of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of 10 mg QD vs 5 mg BID Everolimus: evaluated PK parameters will be a.o. Cmax/Cmin ratio, AUC, Cmax, Cmin, Tmax. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of stomatitis and other adverse events between the two dosing schedules, according to CTC-AE v4.03. | — |
Contacts
Public ContactR.B. Verheijen
Dept. Pharmacy & Pharmacology, Netherlands Cancer Institute - Antoni van Leeuwenhoek
Outcome results
None listed