26 results
To determine the influence of morning versus evening administration on the pharmacokinetics of tamoxifen and its metabolites. Amendment: To determine the influence of time of administration (morning (8 a.m.), afternoon (1 p.m.) and evening (8 p.m…
Inhibition of CYP2D6 enzymes by SSRIs may lead to reduced endoxifen plasma concentrations and thereby possibly influence tamoxifen treatment outcome. Paroxetine is a potent CYP2D6 inhibitor and strongly reduces endoxifen plasma concentrations.…
-To optimize DM-BT by addition of multiple breath sampling and improve it for use in clinical practice-To create a population based pharmacokinetic model based on DM-BT predicting endoxifen serum levels-To identify ideal single or two time points…
- To examine the effects of cytochrome P450 induction by rifampicin on the metabolism and pharmacokinetics of tamoxifen and its metabolites. Induction of cytochrome P450 enzyme expression (including CYP3A4, CYP2C and CYP2D6) by rifampicin will…
Primary: To evaluate the effect of a dose increase to 40mg tamoxifen QD for 4 weeks in patients with at least one CYP2D6 variant allele and/or the presence of a CYP2D6 inhibitorSecondary:To evaluate the effect of concomitant use of (potential)…
To investigate prospectively how the "TAMRO-profile" performs in a pre-operative treatment setting. In addition we can examine whether the profile is specific for tamoxifen or is predictive for endocrine resistance in general. Also the…
• To evaluate the effect of olaparib on exposure to anastrozole by determination of steady-state exposure to anastrozole in the presence and absence of steady-state exposure to olaparib• To evaluate the effect of anastrozole on exposure to olaparib…
This trial studies the effects on quality of life and on time to second progression of the sequence endocrine therapy-capecitabine versus the sequence capecitabine-endocrine treatment. It is anticipated that the time on study (which is the time…
The main objective is: To determine the influence of curcumin with or without piperine, in patients with breast cancer, on endoxifen plasma pharmacokinetics (AUC).Secundary objectives are:1. Other pharmacokinetic outcomes (i.e. clearance, minimum…
The primary efficacy objectives for this study are as follows:* To evaluate the efficacy of etrolizumab (105 mg SC every 4 weeks [Q4W]) compared with placebo for the induction of remission as determined by the MCS at W14* To evaluate the efficacy of…
The objectives of this open-label extension*safety monitoring (OLE-SM) study are as follows: Part 1 (Open-Label Extension; OLE) • To assess the long-term safety and efficacy of etrolizumab in patients eligible for Part 1 (OLE) Part 2 (Safety…
The primary efficacy objective for this study is as follows:* To evaluate the efficacy of etrolizumab (105 mg subcutaneous [SC] every 4 weeks [Q4W]) compared with infliximab in achieving both clinical response at Week (W) 10, and clinical remission…
To determine the influence of concomitant administration of tamoxifen and probenecid on tamoxifen and endoxifen(-glucuronide) plasma concentrations
To compare the plasma concentration of edoxaban in women with breast cancer before and during treatment with tamoxifen.
Primary objective:1. To compare the change from baseline of the Area under the curve (AUC) of tamoxifen in patients with breast cancer treated with tamoxifen with and without green tea supplements.Secondary objectives:1. To compare the Area under…
Induction Phase (IP)* To independently evaluate the efficacy of etrolizumab dose regimens compared with placebo in inducing clinical remission and endoscopic improvement at the end of the Induction Phase (Week 14)Maintenance Phase (MP)* To…
To evaluate the effects of COS with tamoxifen or letrozole compared to standard COS, on oocytes retrieved.
Primary objective1. To compare the Area under the curve (AUC) of endoxifen in patients with breast cancer treated with tamoxifen with and without diclofenac.Secondary objectives1. To compare the Area under the Curve (AUC) of tamoxifen and endoxifen-…
Objective: The primary objective is to assess the effects of continuous monitoring of patients in the acute admission ward (AAW) with a wearable sensor on the percentage of patients who can be discharged home. Secondary objectives are to assess the…
Primary objectives1. To assess the safety of Tam added to Ven. Venetoclax will be dosed at 800 mg once daily. After 2 days of venetoclax, tamoxifen will be orally administrated in a ramp-up phase (2 days 10mg, 2 days 20mg, to a final dose of 40 once…