26 results
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…
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…
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 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…
-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…
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 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…
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…
To compare the plasma concentration of edoxaban in women with breast cancer before and during treatment with tamoxifen.
To test if tamoxifen treatment, compared to placebo, reduces the progression of the disease in 6.5-12 years old ambulant DMD patients by at least 50% (using the MFM D1 subscore as primary clinical endpoint in group A patients).To test if tamoxifen…
Primary Objective1. To prove that TDM of tamoxifen is feasible in clinical practice. Secondary Objectives1. To determine the relation between the pharmacokinetics (PK) of tamoxifen and its metabolites and relevant adverse effects.2. To investigate…
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 Monitoring…
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…
• 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…
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…
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-…
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…