Ignite Creation Date:
2024-05-06 @ 3:55 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02404844
Status:
COMPLETED
Last Update Posted:
2018-04-20
First Post:
2015-02-20
Brief Title:
Trial of BKM120Tamoxifen-combination in Patients With HR-pos HER2-neg Breast Cancer
Sponsor:
University Hospital Essen
Organization:
University Hospital Essen
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIKTAM
Brief Summary:
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 ERPR-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
Detailed Description:
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 ERPR-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 mutationpreserved PTEN expression
PIK3CA wildtype or mutation loss of PTEN expression
PIK3CA wildtypepreserved 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 andor loss of PTEN expression as predictive biomarkers for clinical benefit from combined treatment with BKM120 and tamoxifen
PIK3CA mutationpreserved PTEN expression
PIK3CA wildtype or mutation loss of PTEN expression
PIK3CA wildtypepreserved 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 andor loss of PTEN expression as predictive biomarkers for clinical benefit from combined treatment with BKM120 and tamoxifen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AIO-MAM-0114ass | OTHER_GRANT | AIO | None |
| 2014-000599-24 | EUDRACT_NUMBER | None | None |
| CBKM120ZDE02T | OTHER_GRANT | None | None |