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Clinical Trials

Date: 2016-11-16

Type of information: Presentation of results at a congress

phase: 3

Announcement: presentation of results at the San Antonio Breast Cancer Symposium (SABCS), San Antonio, December 6-10

Company: Novartis (Switzerland)

Product: buparlisib (BKM120)

Action mechanism:

phosphoinositide 3-kinase (PI3K) inhibitor. Buparlisib is an orally bioavailable specific oral inhibitor of the pan-class I phosphatidylinositol 3-kinase (PI3K) family of lipid kinases. It specifically inhibits class I PIK3 in the PI3K/AKT kinase (or protein kinase B) signaling pathway in an ATP-competitive manner, thereby inhibiting activation of the PI3K signaling pathway. This may result in inhibition of tumor cell growth and survival in susceptible tumor cell populations. Activation of the PI3K signaling pathway is frequently associated with tumorigenesis. Dysregulated PI3K signaling may contribute to tumor resistance to a variety of antineoplastic agents. 

Disease: metastatic breast cancer HR+, HER2-

Therapeutic area: Cancer - Oncology

Country: Argentina, Austria, Belgium, Bulgaria, Canada, Colombia, Finland, France, Germany, Greece, Hungary, Italy, Republic of Korea, Lebanon, The Netherlands, Norway, Poland, Spain, Sweden, Thailand, UK, USA, Russian Federation

Trial details:

This study will evaluate whether the addition of daily BKM120 to fulvestrant is effective and safe in treating patients with HR+, HER2-, AI treated locally advanced or metastatic breast cancer who progressed on or after mTor inhibitor based treatment. (NCT01633060 )

Latest news:

* On November 16, 2016,  Novartis announced that it will present data demonstrating the latest advancements from BELLE-3 study at the San Antonio Breast Cancer Symposium (SABCS), San Antonio, December 6-10. BKM120 This Phase III study is evaluating buparlisib and fulvestrant in postmenopausal women with HR+/HER2-, aromatase inhibitor-treated, locally advanced or metastatic breast cancer, who progressed on or after mTOR inhibitor-based treatment. 

Is general: Yes