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Efficacy and Safety of Continued Zoledronic Acid every 4 Weeks versus every 12 Weeks in Women with Bone Metastases from Breast Cancer: Results of the OPTIMIZE-2 Trial Presented By Gabriel Hortobagyi at 2014 ASCO Annual Meeting

Efficacy and Safety of Continued Zoledronic Acid every 4 Weeks versus every 12 Weeks in Women with Bone Metastases from Breast Cancer: Results of the OPTIMIZE-2

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Page 1: Efficacy and Safety of Continued Zoledronic Acid every 4 Weeks versus every 12 Weeks in Women with Bone Metastases from Breast Cancer: Results of the OPTIMIZE-2

Efficacy and Safety of Continued Zoledronic Acid every 4 Weeks versus every 12 Weeks in Women with Bone Metastases from Breast Cancer: Results of the OPTIMIZE-2 Trial

Presented By Gabriel Hortobagyi at 2014 ASCO Annual Meeting

Page 2: Efficacy and Safety of Continued Zoledronic Acid every 4 Weeks versus every 12 Weeks in Women with Bone Metastases from Breast Cancer: Results of the OPTIMIZE-2

Disclosure

Presented By Gabriel Hortobagyi at 2014 ASCO Annual Meeting

Page 3: Efficacy and Safety of Continued Zoledronic Acid every 4 Weeks versus every 12 Weeks in Women with Bone Metastases from Breast Cancer: Results of the OPTIMIZE-2

Outline Slide

Presented By Gabriel Hortobagyi at 2014 ASCO Annual Meeting

Page 4: Efficacy and Safety of Continued Zoledronic Acid every 4 Weeks versus every 12 Weeks in Women with Bone Metastases from Breast Cancer: Results of the OPTIMIZE-2

Background

Presented By Gabriel Hortobagyi at 2014 ASCO Annual Meeting

Page 5: Efficacy and Safety of Continued Zoledronic Acid every 4 Weeks versus every 12 Weeks in Women with Bone Metastases from Breast Cancer: Results of the OPTIMIZE-2

Primary Objective

Presented By Gabriel Hortobagyi at 2014 ASCO Annual Meeting

Page 6: Efficacy and Safety of Continued Zoledronic Acid every 4 Weeks versus every 12 Weeks in Women with Bone Metastases from Breast Cancer: Results of the OPTIMIZE-2

Secondary Objectives

Presented By Gabriel Hortobagyi at 2014 ASCO Annual Meeting

Page 7: Efficacy and Safety of Continued Zoledronic Acid every 4 Weeks versus every 12 Weeks in Women with Bone Metastases from Breast Cancer: Results of the OPTIMIZE-2

Design

Presented By Gabriel Hortobagyi at 2014 ASCO Annual Meeting

Page 8: Efficacy and Safety of Continued Zoledronic Acid every 4 Weeks versus every 12 Weeks in Women with Bone Metastases from Breast Cancer: Results of the OPTIMIZE-2

Final OPTIMIZE-2 study design

Presented By Gabriel Hortobagyi at 2014 ASCO Annual Meeting

Page 9: Efficacy and Safety of Continued Zoledronic Acid every 4 Weeks versus every 12 Weeks in Women with Bone Metastases from Breast Cancer: Results of the OPTIMIZE-2

Demographics, Baseline Characteristics

Presented By Gabriel Hortobagyi at 2014 ASCO Annual Meeting

Page 10: Efficacy and Safety of Continued Zoledronic Acid every 4 Weeks versus every 12 Weeks in Women with Bone Metastases from Breast Cancer: Results of the OPTIMIZE-2

SRE Rate (Primary Endpoint)

Presented By Gabriel Hortobagyi at 2014 ASCO Annual Meeting

Page 11: Efficacy and Safety of Continued Zoledronic Acid every 4 Weeks versus every 12 Weeks in Women with Bone Metastases from Breast Cancer: Results of the OPTIMIZE-2

Time-to-First SRE

Presented By Gabriel Hortobagyi at 2014 ASCO Annual Meeting

Page 12: Efficacy and Safety of Continued Zoledronic Acid every 4 Weeks versus every 12 Weeks in Women with Bone Metastases from Breast Cancer: Results of the OPTIMIZE-2

Skeletal Morbidity Rate (SMR)

Presented By Gabriel Hortobagyi at 2014 ASCO Annual Meeting

Page 13: Efficacy and Safety of Continued Zoledronic Acid every 4 Weeks versus every 12 Weeks in Women with Bone Metastases from Breast Cancer: Results of the OPTIMIZE-2

Safety Summary

Presented By Gabriel Hortobagyi at 2014 ASCO Annual Meeting

Page 14: Efficacy and Safety of Continued Zoledronic Acid every 4 Weeks versus every 12 Weeks in Women with Bone Metastases from Breast Cancer: Results of the OPTIMIZE-2

Bone Markers Change from Baseline

Presented By Gabriel Hortobagyi at 2014 ASCO Annual Meeting

Page 15: Efficacy and Safety of Continued Zoledronic Acid every 4 Weeks versus every 12 Weeks in Women with Bone Metastases from Breast Cancer: Results of the OPTIMIZE-2

Conclusions

Presented By Gabriel Hortobagyi at 2014 ASCO Annual Meeting

Page 16: Efficacy and Safety of Continued Zoledronic Acid every 4 Weeks versus every 12 Weeks in Women with Bone Metastases from Breast Cancer: Results of the OPTIMIZE-2

Back Ups

Presented By Gabriel Hortobagyi at 2014 ASCO Annual Meeting

Page 17: Efficacy and Safety of Continued Zoledronic Acid every 4 Weeks versus every 12 Weeks in Women with Bone Metastases from Breast Cancer: Results of the OPTIMIZE-2

Number of Infusions Prior to Study

Presented By Gabriel Hortobagyi at 2014 ASCO Annual Meeting

Page 18: Efficacy and Safety of Continued Zoledronic Acid every 4 Weeks versus every 12 Weeks in Women with Bone Metastases from Breast Cancer: Results of the OPTIMIZE-2

Renal Adverse Events

Presented By Gabriel Hortobagyi at 2014 ASCO Annual Meeting