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S1207 An Upcoming Trial for High-Risk Breast Cancer - SWOG

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4/22/2013<br />

BOLERO‐2<br />

• Addition of everolimus to exemestane prolongs<br />

PFS in patients with ER+ HER2‐ breast cancer<br />

refractory to nonsteroidal aromatase inhibitors.<br />

◦ Local: median 7.4 vs. 3.2 months (HR = 0.44, P < 1 x 10 ‐16)<br />

◦ Central: median 11.0 vs. 4.1 months (HR = 0.36, P < 1 x 10 ‐16)<br />

• Benefit is observed in all subgroups.<br />

• QOL was similar in the two arms.<br />

• Adverse events were consistent with previous<br />

experience with everolimus.<br />

10<br />

Benefit of Systemic Therapy- Ox<strong>for</strong>d Overview<br />

Ox<strong>for</strong>d Overview, 2006<br />

<strong>S1207</strong> Background<br />

• Abnormalities of the PI3kinase/AKT/mTOR<br />

signaling network are some of the most<br />

common molecular anomalies in breast cancer.<br />

• This pathway has been associated with<br />

resistance to endocrine therapies among HRpositive<br />

breast tumors.<br />

• Everolimus, an mTOR-inhibitor, has been<br />

shown to increase the biological activity of<br />

aromatase inhibitors.<br />

4

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