for females ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion



The purpose of this study is to determine wether the addition of daily BKM120 to fulvestrant is effective and safe in treating patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer refractory to aromatase inhibitor.

Official Title

A Phase III Randomized, Double Blind Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative Locally Advanced or Metastatic Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment


Breast CancerHormone receptor positiveHER2-negativeMetastaticLocally advancedPI3KFulvestrantRefractoryAromatase inhibitorBreast NeoplasmsHormonesAromatase InhibitorsBKM120BKM120 and fulvestrant


You can join if…

Open to females ages 18 years and up

  • Locally advanced or metastatic breast cancer
  • HER2-negative and hormone receptor-positive status (common breast cancer classification tests)
  • Postmenopausal woman
  • A tumor sample must be shipped to a Novartis designated laboratory for identification of biomarkers (PI3K activation status)
  • Progression or recurrence of breast cancer while on or after aromatase inhibitor treatment
  • Measurable disease or non measurable disease bone lesions in the absence of measurable disease as per RECIST 1.1
  • Adequate bone marrow and organ function defined by laboratory values

You CAN'T join if...

  • Previous treatment with PI3K inhibitors, AKT inhibitors, mTOR inhibitor or fulvestrant
  • More than one prior chemotherapy line for metastatic disease
  • Symptomatic brain metastases
  • Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent
  • Active heart (cardiac) disease as defined in the protocol
  • Certain scores on an anxiety and depression mood questionnaires
  • Other protocol-defined inclusion/exclusion criteria may apply


  • University of California San Diego - Moores Cancer Center UCSD 3
    La JollaCalifornia92093-0658United States
  • St. Jude Heritage Medical Group Virginia Crosson Cancer Center
    FullertonCalifornia92835United States


in progress, not accepting new patients
Start Date
Completion Date
Novartis Pharmaceuticals
Phase 3
Study Type
Last Updated