22 results
Primary* To determine the maximum tolerated dose or recommended phase 2 dose of oral BYL719 as single agent and in combination with fulvestrantSecondary* To assess the overall safety and tolerability of BYL719 as single agent and in combination with…
Primary: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (full…
Primary: treatment effect of TKI258 in combination with fulvestrant vs. fulvestrant plus placebo on Progression-Free Survival (voor for each of the 2 groups, namely FGF pathway amplified and regardless of FGF pathway amplification status).Secondary…
to improve RV function adult patients with RV dysfunction due to tetralogy of Fallot
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 aim of this study is to quantify residual ER binding sites during fulvestrant therapy, compared to the tracer uptake prior to fulvestrant therapy.
This study is intended to assess the safety and performance of the ACT Catheter for ablation of right atrial isthmus dependent flutter, also known as typical atrial flutter.
In this single centre pilot intervention study, we will investigate the effects of short-term administration of the angiotensin-receptor antagonist losartan on insulin sensitivity (assessed by using the homeostasis model assessment of insulin…
1. The effect of Losartan on the joint excursions and the Hardening of the skin in a patient with SSS.2. Gain insight in the pathogenesis of SSS3. Gain insight in the functional effect of Losartan in SSS.
2.1 Primary objectiveTo assess the rate of no progression (NPR) at 8 weeks following treatment with the combination of gefitinib and fulvestrant in EGFR mutated patients who failed previous treatment with reversible EGFR TKI*s (gefitinib or…
Primary: The primary objective is to determine whether treatment with alpelisib in combination with fulvestrant prolongs progression free survival (PFS) compared to treatment with placebo in combination with fulvestrant based on local radiological…
To assess the effect of Ziverel on esophageal sensitivity to acid, mucosal barrier function and reflux symptoms in patients with PPI-refractory reflux symptoms.
Primary: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (unkown status…
Primary ObjectiveTo evaluate the antitumor activity of tucatinib given in combination with trastuzumab in subjects with previously treated, locally-advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2) overexpressing/…
To examine the impact of medication induced systolic BP (SBP) reductions >=10 mmHg, while reaching a treatment target of <=140 mmHg, on cerebral blood flow (CBF) in frail elderly with untreated or uncontrolled systolic hypertension at…
Evaluate the efficacy of the ER-antagonist Fulvestrant in women with estrogen receptor positive (ER+) low grade gynecological cancers
To assess the proportion of patients who are alive without disease progression at 6 months based on local investigator assessment per RECIST v1.1 in cohort A and cohort B 13-03-2019: new cohort added (3 cohorts now)
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…
Primary objective:To test the hypothesis that the calcium channel blocker amlodipine has a superior beneficial effect on cerebrovascular reactivity in patients with symptomatic SVDs when compared to either the Angiotensin II type 1 (AT1) receptor…
Primary: To compare PFS between ribociclib plus fulvestrant to fulvestrant monotherapy (plus placebo) among men and postmenopausal women with HR+, HER2-negative advanced breast cancer who received no or only one prior endocrine treatment for…