82 / 1851
PART 1 = Equal Randomization
(1:1)
Chemo only
Chemo + PI3Ki
Objective Response Rate,
or Progressive Free Survival
Adaptive Design
(Biomarker Guided) (n=150-200)
PART 2 = Adaptive
Randomization
testing
two markers
2
nd
assessment of
Objective Response Rate,
or Progressive Free Survival
Equal Randomization (1:1)
Chemo only
Chemo + PI3Ki
Randomized Design
(n=400-500)
Progressive Free Survival
BY BIOMARKER
Advanced Stage, ER+ HER2-
Hormone Refractory
Advanced Stage, ER+ HER2-
Hormone Refractory
BIOMARKER 1
PIK3CA mutation
BIOMARKER 2
LumA vs LumB
BIOMARKER 3
PTEN loss (IHC)
BIOMARKER 4
AKT1 mutation
BIOMARKER 5
pAKT (IHC)
BIOMARKER 6
Expression Signature(s)
BIOMARKER 7
others
Testing A Predictive Biomarker?