West Cancer Center

BREAST: Metastatic: ER/PR+; HER2-; post-mTORi: "BELLE-3"

A Phase III Randomized, Double Blind, Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTOR Inhibitor Based Treatment_

Title

Novartis CBKM120F2303

Study Title

Site Link

NCT01633060

Malignancy

Breast, Metastatic Hormone Receptor Positive Breast Cancer

Stage

Stage 4

Disease Setting

Metastatic/palliative

Line Of Therapy

1st line chemo (after failure of mTOR inhibitor)2nd line chemo�(after failure of mTORi AND one line of chemo)

Investigational Agent

BKM120

Drug Class

Pan-class 1 PI3K inhibitor

Jason Chandler, MD

Sponsor

Novartis Pharmaceuticals

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT01633060?term=Novartis+CBKM120F2303&rank=1

Key Eligibility Criteria Details

Postmenopausal women
Locally advanced or metastatic breast cancer
HER2-, ER/PR+
Most recent progression must be on combination mTORi and AI
No more than one prior metastatic chemo regimen
No chronic steroid treatment
No active cardiac disease

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Objective

Primary- PFS: Secondary- OS, ORR, Clinical Benefit Rate, safety, QoL, PK

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

ER/PR positive (+)HER2 negative (-)

Dosing Frequency

BKM120 100mg daily, Fulvestrant 500mg q4 weeks (q2 weeks during first cycle)

Control Agents

Fulvestrant and placebo

Study Protocol

Randomized

Yes