NCT01248494

PhIb BKM120 or BEZ235+Endocrine Treatment in Post-Menopausal Patients With Hormone Receptor + Metastatic Breast Cancer

A Phase Ib Trial of BKM120 (a PI3K Inhibitor) or BEZ235 (a PI3K/mTOR Inhibitor) in Combination With Endocrine Therapy in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label phase Ib multi-institution trial that evaluates the safety profile/tolerability and preliminary anti-tumor effect of BKM120 (a PI3K inhibitor) and endocrine therapy combination and BEZ235 (a PI3K/ mTOR inhibitor) and endocrine therapy combination in postmenopausal patients with hormone receptor-positive metastatic breast cancer.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	BEZ235	* Dose level 1: 400mg PO BID * Dose level -1: 400mg PO in AM and 200mg PO in PM * Dose level -2: 200mg PO BID
DRUG	BKM 120	* Dose Level 1: BKM120, 100 mg PO daily * Dose level -1: BKM120, 80 mg PO daily * Dose Level -2: BKM120, 60 mg PO daily
DRUG	Letrozole	All levels: 2.5mg/day PO
DRUG	BKM120	* Dose Level 1: BKM120, 100 mg PO from Mondays through Fridays, weekly * Dose level -1: BKM120, 80 mg PO from Mondays through Fridays, weekly * Dose Level -2: BKM120, 60 mg PO from Mondays through Fridays, weekly

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-12-01
• Completion: 2016-05-01
• First posted: 2010-11-25
• Last updated: 2016-07-25

Locations

6 sites across 1 country: United States