13 results
A phase Ib / II randomized study of BI 836845 in combination with exemestane and everolimus versus exemestane and everolimus alone in women with locally advanced or metastatic breast cancer.With following objectives:Phase Ib part: To determine the…
The primary objective is to assess safety and efficacy of abiraterone acetate plus prednisone and abiraterone acetate plus prednisone plus exemestane, each compared with exemestane alone, in postmenopausal women with ER+ metastatic breast cancer…
Primary: to estimate progression-free survival in patients treated with everolimus + letrozole in the first line setting.Secondary: overall response rate, clinical benefit rate, overall survival in the first line setting, progression free survival…
To compare the combination treatment of everolimus and exemestane to exemestane alone with respect to progression-free survival in postmenopausal women with estrogen receptor positive breast cancer that is refractory to non-steroidal aromatase…
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…
The primary objective is to demonstrate the efficacy using 2 co-primary endpoints (as measured by thechanges from baseline to the end of Week 16 in Western Ontario and McMaster UniversityOsteoarthritis Index [WOMAC] pain and physical function…
Objecive of phase I was the determination of the maximum tolerated dose (MTD) and recommended phase II dose of BI836845 in combination with exemestane and everolimus in women with HR+ / HER2- locally advanced or metastatic breast cancer.Ojective of…
In this side-study proposal we plan to gain more insight in tumor characteristics in order to predict which patients will have a high chance of a long progression-free survival. Study objectives: 1. It is proposed to compare progression-free…
To describe and compare pharmacokinetics of everolimus in a 10 mg QD and everolimus 5mg BID schedule, evaluated PK parameters will be a.o. Cmax/Cmin ratio, AUC, Cmax, Cmin, Tmax.
The objective of this study is to assess efficacy and safety of radium 223 dichloride in combination with exemestane and everolimus in subjects with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor positive breast cancer…
Main objective:•To compare the progression-free survival of imlunestrant (Arm A) to the standard comparator of Investigator's Choice Endocrine Therapy of either fulvestrant or exemestane (Arm B) in the ITT population•To compare the PFS of Arm…
Primary objectives:- To confirm the haemostatic effect of Mim8 as treatment prophylaxis for adult and adolescent patients with haemophilia A with or without inhibitors.Secondary objectives:- To investigate safety of Mim8 prophylaxis in adults and…
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…