15 results
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* 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: 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 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.
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…
To determine in all-comers patients undergoing PCI under standardised treatment (including the BioMatrix family of drug-eluting stents and bivalirudin), whether treatment with 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor…
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: 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…
Evaluate the efficacy of the ER-antagonist Fulvestrant in women with estrogen receptor positive (ER+) low grade gynecological cancers
Primary Objective:• To investigate the efficacy of KVD900 compared to placebo in halting the progression of a peripheral or abdominal attack of hereditary angioedema (HAE).Secondary Objectives:• To investigate the safety and tolerability of KVD900…
Primary Objective: To demonstrate the clinical efficacy of KVD900 compared with placebo for the on-demand treatment of HAE attacks.Secondary Objective: To investigate the safety and tolerability of KVD900.
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 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)
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…