Milademetan and Fulvestrant in GATA3-mutant, ER+HER- Advanced or Metastatic Breast Cancer
Status:
Terminated
Trial end date:
2023-11-30
Target enrollment:
Participant gender:
Summary
This is a single arm, multicentric phase II study of milademetan plus fulvestrant in patients
with ER+, HER2- ABC harboring GATA3 mutation(s) in the tumor and/or in ctDNA who have
progressed on or after prior treatments including a CDK4/6 inhibitor.
Frameshift or truncating GATA3 mutations will be identified by next generation sequencing
(NGS) performed on either tissue or circulating DNA. Given the well-known safety profile of
fulvestrant and the absence of significant toxicity expected from the association of
fulvestrant and milademetan, a safety run-in is planned. During the course of the study, the
Steering Committee will specifically review the occurrence of toxicities defined as DLTs in
the safety run-in.