10 results
The primary objective of this trial is to study the effect of the moderate CYP3A4 inhibitor erythromycin on the pharmacokinetics of palbociclib, measured as AUC0-24h, Cmax and Cmin.The secondary objective of this trial is to compare the incidence…
Primary Objective:To compare invasive disease-free survival (iDFS) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed…
To evaluate in a feasibility study whether low uptake on FES-PET at baseline is related to non-response to letrozole plus palbociclib treatment.
Primary Objective:- To demonstrate the superiority of palbociclib in combination with fulvestrant (with or without goserelin) over fulvestrant alone (with or without goserelin) in prolonging investigator-assessed PFS in women with HR+/HER2-negative…
The aim is to improve compliance to the ERAS protocol. Therefore an application for smartphone will be developed to be used by the patient undergoing colorectal surgery. Objective of this study is to generate evidence that a mobile app can activate…
The aim of this study is to better understand the role of mammary lactation physiology and breast composition in regulating breast milk transfer during milk extraction. The secondary aim is to validate the performance of diffuse optical…
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: To compare the efficacy of palbociclib in combination with TMZ and IRN vs TMZ and IRN chemotherapy alone in the treatment of children, adolescents, and young adults with recurrent or refractory EWS.Secundary: To further compare the efficacy…
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 aim of the study is to map the changes that occur in breast tissue composition during pregnancy, lactation and post-lactational involution. The secondary aims are to:• validate the performance of diffuse optical spectroscopic imaging (DOSI)…