Evaluation of Everolimus (EVE) in HER2+ Advanced Breast Cancer (BC) with Activated PI3K/mTOR Pathway: Exploratory Biomarker Observations from the BOLERO-3 Trial Guy Jerusalem, 1 Fabrice André, 2 David Chen, 3 Douglas Robinson, 3 Mustafa Ozguroglu, 4 Istvan Lang, 5 Michelle White, 6 Masakazu Toi, 7 Tetiana Taran, 3 Luca Gianni 8 1 CHU Sart Tilman Liège and University of Liège, Liège, Belgium; 2 Institut Gustav Roussy, Villejuif, France; 3 Novartis Pharmaceuticals, East Hanover, New Jersey, USA; 4 Cerrahpasa Medical Faculty, Istanbul University, Istanbul, Turkey; 5 Országos Onkológiai Intézet, Budapest, Hungary; 6 Monash Medical Center Moorabbin, Victoria, Australia; 7 Kyoto University, Kyoto, Japan; 8 Ospedale San Raffaele, Milan, Italy
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Evaluation of Everolimus (EVE) in
HER2+ Advanced Breast Cancer (BC)
with Activated PI3K/mTOR Pathway:
Exploratory Biomarker Observations
from the BOLERO-3 Trial
Guy Jerusalem,1 Fabrice André,2 David Chen,3
Douglas Robinson,3 Mustafa Ozguroglu,4
Istvan Lang,5 Michelle White,6 Masakazu Toi,7
Tetiana Taran,3 Luca Gianni8 1CHU Sart Tilman Liège and University of Liège, Liège, Belgium;
2Institut Gustav Roussy, Villejuif, France; 3Novartis Pharmaceuticals,
East Hanover, New Jersey, USA; 4Cerrahpasa Medical Faculty, Istanbul
University, Istanbul, Turkey; 5Országos Onkológiai Intézet, Budapest,
Hungary; 6Monash Medical Center Moorabbin, Victoria, Australia; 7Kyoto University, Kyoto, Japan; 8Ospedale San Raffaele, Milan, Italy
Disclosures
• Study supported by funding from Novartis
– ClinicalTrials.gov identifier NCT01007942
• Ownership: D. Chen, D. Robinson, and T. Taran are
Novartis stockholders
• Advisory board: G. Jerusalem, A. Fabrice, M. Ozguroglu,
and M. White for Novartis; L. Gianni for Novartis, Roche,
Genentech, GSK, Pfizer, BI, Celgene, Tahio
• Corporate-sponsored research: G. Jerusalem, F. Andre,
D. Chen, D. Robinson, M. Ozguroglu, M. Toi, and T. Taran
for Novartis
• Other substantive relationships: G. Jerusalem is a
consultant to Novartis; M. Ozguroglu is a steering
committee member for Novartis-sponsored trials
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BOLERO-3: Study Design
*Actual enrollment was 569. †Following a 4-mg/kg loading dose on day 1, cycle 1 (1 cycle = every 21 days).