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Association details:
Evidence:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

LBA20 - Vandetanib plus fulvestrant versus placebo plus fulvestrant after relapse or progression on an aromatase inhibitor in metastatic ER positive breast cancer (FURVA): A randomised, double-blind, placebo-controlled, phase II trial

Published date:
09/19/2020
Excerpt:
AI resistant patients were recruited from 19 UK sites and randomly assigned (1:1) to fulvestrant 500mg (day 1 and 15 of cycle 1 and day 1 only of subsequent 28 day cycles) with either vandetanib 300mg (f+v) or placebo (f+p) daily until disease progression, unacceptable toxicity or withdrawal of consent. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), safety, and the influence of RET signalling pathway component expression (e.g. total RET immunostaining) on vandetanib activity....high total RET protein expression was associated with a significant PFS advantage of 8.87m vs 3.94m in the low RET group (HR 0.493: 95% CI 0.32 to 0.77; p=0.002), which was independent of treatment arm.
Secondary therapy:
fulvestrant