Breast Cancer Clinical Trial
Official title:
Molecularly Stratified Parallel Cohort, Single Arm Phase II Trial of the Phosphoinositide 3-kinase (PI3K) Inhibitor Buparlisib (BKM120) in Combination With Tamoxifen in Patients With Hormone Receptor-positive, HER2-negative Inoperable (Locally Advanced or Metastatic) Breast Cancer With Prior Exposure to Antihormonal Therapy
This is a clinical trial with a molecularly stratified parallel cohort, single arm design to explore the efficacy and safety of BKM120 in combination with tamoxifen in patients with ER/PR-positive, HER2-negative breast cancer with prior exposure to antihormonal therapy, and different biomarker profiles, two of them potentially indicative of constitutive PI3K pathway activation.
This is a clinical trial with a molecularly stratified parallel cohort, single arm design to
explore the efficacy and safety of BKM120 in combination with tamoxifen in patients with
ER/PR-positive, HER2-negative breast cancer with prior exposure to antihormonal therapy, and
different biomarker profiles, two of them potentially indicative of constitutive PI3K pathway
activation:
- PIK3CA mutation/preserved PTEN expression
- PIK3CA wildtype or mutation/ loss of PTEN expression
- PIK3CA wildtype/preserved PTEN expression. This trial will explore, if the combination
of BKM120 and tamoxifen can overcome resistance to antihormonal therapies. BKM120 is
selective for class I PI3K enzymes with no mTOR inhibitory activity that has entered
Phase II and III clinical trials. The tumor suppressor PTEN is the most important
negative regulator of the PI3K signaling pathway. Therefore, in addition the trial will
prospectively evaluate PIK3CA mutations and/or loss of PTEN expression as predictive
biomarkers for clinical benefit from combined treatment with BKM120 and tamoxifen.
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