Phase II clinical trial - Sein métastatique RH+

SERENA-2 (D8530C00002)
Sein métastatique RH+
Essai clinique fermé
Public cible
SERENA-2: A Randomised, Open-Label, Parallel-Group, Multicentre Phase;2 Study Comparing the Efficacy and Safety of Oral AZD9833 versus;Fulvestrant in Women with Advanced ER-Positive HER2-Negative Breast;Cancer
Description de l'essai
The oestrogen receptor (ER) alpha (ERa) is a well-established drug target in breast cancer;with anti-hormonal endocrine therapies being the mainstay of treatment (Early Breast Cancer;TrialistsÀ Collaborative Group 2005). The selective ER degrader (SERD) and antagonist;fulvestrant is used as a standard-of-care treatment for ER-positive metastatic breast cancer;(Cardoso et al 2018).;Although fulvestrant has demonstrated superior clinical efficacy to other endocrine therapies;in this metastatic setting, it is not orally bioavailable and the monthly intramuscular (IM) route;of administration may limit its efficacy (Robertson 2007, Robertson et al 2014).;AZD9833 is an orally bioavailable SERD which is being developed for the treatment of;women with ER-positive breast cancer.;AZD9833 has the potential to provide superior clinical benefit to existing endocrine therapies;through enhanced bioavailability, target engagement and modulation in patients with;ER-positive breast cancer.
Investigateur principal