24 results
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…
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…
- 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 assess the feasibility and efficacy of 90Y-ibritumomab tiuxetan consolidation treatment after R-PECC chemotherapy as second or third line treatment in patients with refractory or relapsed aggressive B-cell NHL, after or not eligible for…
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.…
The primary objective of the study is to demonstrate clinically relevant statistical superiority in progression-free survival (PFS) with GClb compared to RClb and Clb alone and RClb compared to Clb [GClb vs Clb; GClb vs RClb; RClb vs Clb] in…
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…
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…
To compare invasive disease-free survival (iDFS) for ribociclib + ET versus placebo + ET in patients with HR-positive, HER2-negative, EBCwith high risk of recurrence.
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 determine the influence of concomitant administration of tamoxifen and probenecid on tamoxifen and endoxifen(-glucuronide) plasma concentrations
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-…
Primary objective:-To assess whether ixekizumab is superior to adalimumab at Week 24 in the treatment of patients with active PsA as measured by American Collegeof Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI 100)Major…
Co-Primary- to assess whether ixekizumab Q4W is superior to placebo at Week 12 (Visit 7) in the treatment of pediatric subjects(children and adolescents) with moderate-to-severe plaque psoriasis as measured by PASI 75 and by sPGA (0,1)Gated…
To evaluate the effects of COS with tamoxifen or letrozole compared to standard COS, on oocytes retrieved.
The primary goal is to investigate whether controlled dose reduction of IL17 or IL23 inhibiting biologics is not inferior compared to usual care. This is measured by comparing the proportion of long-term disease flares between the two groups (dose…
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…
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…