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Sasikiran Goteti

Novartis

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BELLE-3: A Phase III study of the pan-phosphatidylinositol 3-kinase (PI3K) inhibitor buparlisib (BKM120) with fulvestrant in postmenopausal women with HR+/HER2- locally advanced/metastatic breast cancer (BC) pretreated with aromatase inhibitors (AIs) and refractory to mTOR inhibitor (mTORi)-based treatment.

2015 Journal of Clinical Oncology
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Insummary,Freidlinetal 1 giveanexcellentoverviewofdifferent approaches to designs that integrate B, B-, and overall populations. For implementation in practice, several considerations need to be taken into account, such as the role of B-, how to address complex objectiveswithmultipleendpointsandpopulations,andtheutilityof adaptive designs with population selection.

2014
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Some Practical Considerations for Phase III Studies With Biomarker Evaluations

2014 Journal of Clinical Oncology
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