207_Combined course Presentations

Testing A Predictive Biomarker?

Adaptive Design (Biomarker Guided) (n=150-200)

Randomized Design (n=400-500)

Advanced Stage, ER+ HER2- Hormone Refractory

Advanced Stage, ER+ HER2- Hormone Refractory

PART 1 = Equal Randomization (1:1)

Equal Randomization (1:1)

BIOMARKER 1 PIK3CA mutation

Chemo only

Chemo + PI3Ki

Chemo only

Chemo + PI3Ki

Objective Response Rate, or Progressive Free Survival

BIOMARKER 2 LumA vs LumB

BIOMARKER 3 PTEN loss (IHC)

PART 2 = Adaptive Randomization testing two markers

BIOMARKER 4 AKT1 mutation

BIOMARKER 5 pAKT (IHC)

BIOMARKER 6 Expression Signature(s)

BIOMARKER 7 others

2 nd assessment of Objective Response Rate, or Progressive Free Survival

Progressive Free Survival BY BIOMARKER