A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi (BELLE-3)

December 07, 2012
BELLE-3
Breast Cancer
Joseph Kash, MD

Naperville, Plainfield

This study will evaluate whether the addition of daily BKM120 to fulvestrant is effective and safe in treating patients with HR+, HER2-, AI treated locally advanced or metastatic breast cancer who progressed on or after mTor inhibitor based treatment.

Sponsor: Novartis Pharmaceuticals Corp

http://clinicaltrials.gov/ct2/show/NCT01633060?term=NCT01633060&rank=1

  • Postmenopausal women
  • Breast cancer that is locally advanced or metastatic
  • HER2 negative disease
  • Prior treatment with AIs
  • Evidence of progression to the combination of mTORi and endocrine therapy given as the last therapy prior to study entry
  • Adequate bone marrow and organ function

Exclusion Criteria:
  • More than 1 prior chemotherapy given for locally advanced or metastatic disease
  • Previous treatment with PI3K inhibitors, AKT inhibitors or fulvestrant
  • Symptomatic CNS metastases
  • Concurrent malignancy or malignancy within 3 years prior to start of study treatment
  • Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent
  • Active heart (cardiac) disease or a history of cardiac dysfunction 

2-5 years

Accepting Participants
Interventional
III
Kathy Seymour, BSN
630-646-6056
630-646-6110
630-646-6075