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A phase II, multicenter, open-label study of EGF816 in combination with Nivolumab in adult patients with EGFR mutated non-small cell lung cancer and of INC280 in combination with Nivolumab in adult patients with cMet positive non-small cell lung cancer (CEGF816X2201C)

Primary: To assess 6 month PFS rate of Nivolumab in combination with EGF816 in EGFR mutated NSCLC patients and of Nivolumab in combination with INC280 in patients with cMET positive NSCLC patientsSecondary: 1: To assess clinical activity of…

Image quality of MR-Imaging on the MR-High Intensity Focused Ultrasound breast system

Primary objectivesWhat is the quality of MR images acquired on the MR-HIFU breast system in volunteers and patients with a fibroadenoma relative to the quality of MR images acquired on a conventional diagnostic 3-Tesla MRI scanner? We will assess…

The influence of time of administration on tamoxifen pharmacokinetics.

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…

Safety of TKI concurrent with cranial radiotherapy in NSCLC patients; the SATIN platform trial

Primary Objectives: - To assess whether there is an increase in acute severe toxicity (per TKI cohort) 2 weeks after completion of cranial radiotherapy measured with CTCAE v 4.0. - To assess whether there is an increase in neurotoxicity (measured…

A Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator*s Choice of Endocrine Therapy, and Imlunestrant plus Abemaciclib in Patients with Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated with Endocrine Therapy

This study has been transitioned to CTIS with ID 2023-506786-63-00 check the CTIS register for the current data. Main objective:•To compare the progression-free survival of imlunestrant (Arm A) to the standard comparator of Investigator's…

Pilot study: Dystrophyc pathways in human hair follicles after chemotherapy with or without scalp cooling.

We will explore the influence of chemotherapy on hair follicles. Scalp cooling works, but not in every patient. When we understand the working mechanism of chemotherapy induced alopecia, we can possibly explain why scalp cooling works in one patient…

A phase III, multicenter, randomized, double-blind, placebo-controlled study to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, high risk early breast cancer

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.