18 results
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…
To compare the safety and efficacy of different doses and regimens of Allocetra-OTS to that of Placebo in the treatment of organ failure in adult sepsis patients
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:• Determine if ribociclib plus letrozole gives a >=100% improvement in complete cell cycle arrest (CCCA; defined as Ki67 IHC <1%) as compared to chemotherapy in the surgical specimen*.Secondary objective• Study 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…
• 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…
PrimaryTo investigate whether 5 years of extended adjuvant treatment with letrozole results in an improved DFS compared to 2.5 years treatment in patients with early breast cancer previously treated with endocrine agents for 5 yearsSecondaryTo…
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…
Primary objective: To estimate the difference in anti-proliferative activity of LEE011 600 mg QD and LEE011 400 mg QD in combination with letrozole 2.5 mg QD vs single agent letrozole 2.5 mg QD as measured by changes in Ki-67 levels from baseline to…
To evaluate the effects of COS with tamoxifen or letrozole compared to standard COS, on oocytes retrieved.
Primary objective: Determine whether treatment with a PI3K inhibitor (BYL719 or buparlisib) plus letrozole leads to an increase in pathologic response compared to treatment with placebo plus letrozole in patients with hormone receptor-positive HER2-…
Primary: 1/ To evaluate the safety and tolerability of ribociclib with letrozole in men and postmenopausal women with HR+, HER2- aBC who received no prior hormonal therapy for advanced disease.Secondary: To assess the clinical efficacy of ribociclib…
This study aims to investigate the progression-free survival (PFS) according to RECIST 1.1 criteria on matched targeted therapy by STA-analysis (PFS2) in comparison to the PFS recorded on the therapy administered immediately prior to enrolment (PFS1…
The primary objective of this study is to determine whether SAR439859 in combination with palbociclib improves progression free survival (PFS) compared to letrozole in combination with palbociclib in patients with ER +, HER2-advanced breast cancer…
The purpose of this study is to compare STZ vs everolimus as first line treatment for advanced pNET and elucidate which sequence of STZ based chemotherapy and the mTOR inhibitor, everolimus, gives better results in terms of PFS in well…
Primary objective: Progression free survival (PFS) of treatment with letrozole plus LEE011 compared to treatment with letrozole plus placebo .Secondary objectives: Overall survival (OS), overall response rate (OR), overall clinical benefit rate,…
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…