13 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…
• 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…
Primary• To assess the safety profile and determine the pediatric maximum tolerated dose and/or recommended phase 2 dose of brentuximab vedotin• To assess the pharmacokinetics of brentuximab vedotin• To determine the overall response rate (complete…
To compare the clinical and cost-effectiveness of an anterior colporraphy repair with a cystocele repair with the use of the non-absorbable synthetic Avaulta® mesh.
The primary objective of Study I3Y-MC-JPBY (JPBY) is to compare the biological activity ofabemaciclib in combination with anastrozole, abemaciclib monotherapy, and anastrozole monotherapy byassessing the percentage change from the baseline value in…
Lead in phase 1Primary objective:• To identify the feasibility and RDL (recommended dose level) of brentuximab vedotin in combination with R-DHAPSecondary objective:• To assess the toxicity of brentuximab vedotin in combination with R-DHAP• To…
The primary objective of the study is to evaluate if treatment with a non-steroidal aromatase inhibitor combined with CDK4/6 inhibition in first line followed at progression by fulvestrant in second line (strategy A) improves progression-free…
There are two treatment groups in this study: one with participants at low risk of deterioration and one with participants at standard risk of deterioration. The primary objective for each group is described below.-Low Risk group: To describe the…
The primary objective of Study I3Y-MC-JPBM is to compare treatment with LY2835219 plus NSAI therapy versus placebo plus NSAI therapy with respect to PFS in postmenopausal women with HR+, HER2- locoregionally recurrent or metastatic breast cancer who…
primary objective of the trial is to demonstrate non-inferior efficacy of 4-6 cycles of BrECADD compared to 4-6 cycles of escalated BEACOPP, each followed by radiotherapy on PET-positive residual lesions, in terms of progression free survival (…
• Determine a feasible 89Zr-brentuximab-PET imaging schedule, to allow assessment of the biodistribution of 89Zr-brentuximab in tumor and non-target lesions or -organs.• Establish safety profile, pharmacokinetics (PK), and pharmacodynamics (PD) of…
Primary Objective: To determine the effect of sex hormones on bone marrow fat. and visceral fatSecondary Objective(s): * To determine the effect of sex hormones on visceral and liver fat.* To test whether DXA can be used to calculate the amount of…
To demonstrate superiority of giredestrant over the control treatment in preventing breast cancer recurrence.Secondary objectives• To evaluate the efficacy of giredestrant compared with TPC in terms of overall survival andother measures• To evaluate…