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“Genome-Forward” Trials
Mutation
Present
2-week
Biopsy for Ki67
S
U
R
G
E
R
Y
Ki67 > 10%
Surgery or Chemotherapy at the
discretion of treating physician
B
I
O
P
S
Y
16 weeks (4 x 28-day Cycle)
Tumor
PIK3CA
Mutation Analysis
Clinical
Stage II
or III
ER+
(Allred 6-
8)
HER2-
Breast
Cancer
Cycle 0
(days -28 to -1)
Anastrozole
AKT inhibitor Trial
MK-2206 PO (Days 1, 8, 15, 22)
+ Anastrozole PO Daily
Primary endpoint: pCR rate
Cdk4/6 inhibitor Trial
PD991 PO (Days 1-21) x 4 cycles
+ Anastrozole PO Daily
Mutation
Absent
SURGERY
2 stage design:
1
st
stage: n=13
2
nd
stage: n=16