Studieoverzicht - 2013-05 BELLE-3

Number 2013-05 BELLE-3
Nickname BELLE-3
Status Follow up Date: 04-03-2016
Inclusion closed 04-03-2016
Other study number(s) CBKM120F2303
Participating parties/groups
Full title A phase III randomized, double blind placebo controlled study of oral BKM120 in combination with fulvestrant, in the treatment of postmenopausal women with hormone receptor-positive HER2-negative locally advanced or metastatic breast cancer whose disease has progressed on or after aromatase and mTOR inhibitor treatment.
Phase and type Randomized Phase III
Age ≥18
Menopausal status Postmenopausal
Indication Advanced/metastatic
Subindication HER2- HR+
Target sample size 420
Actual accrual 432 (NL: 22) Date: 04-03-2016
Estimated study completion date 31-03-2016
CCMO approval Yes Date: Nr:
EudraCT nr.
Trial Register
METC approval Yes Date: METC: Nr:
Amendments Date:
KWF-CKS approval No Date: Nr:
News item
Sponsor Novartis
Principal Investigator(s) V.C.G. Tjan-Heijnen (MUMC)
Study manager G. Frans (Novartis)
A.E. van Leeuwen-Stok (BOOG Study Center)
Central datamanagement and randomization Novartis
Monitoring Novartis
Local datamanagement
Extra E. van Druten (Research Nurse - coordination, RdGG)


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.


Primary Outcome Measures: Progression Free Survival (PFS).

Secondary Outcome Measures: Overall survival (OS); Overall response rate (ORR); Clinical benefit rate (CBR); Type, frequency and severity of adverse events; Plasma concentration-time profiles of BKM120 - pharmacokinetics (PK); Patient reported outcome for global health status/QoL

Main eligibility criteria:

Inclusion criteria:

  • Postmenopausal women
  • Breast cancer that is locally advanced or metastatic
  • HER2 negative disease, and a known positive hormone receptor status (common breast cancer classification tests)
  • A tumor sample must be shipped to a central lab for identification of biomarkers (PI3K activation status) before randomization
  • 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
  • Certain drugs or radiation within 2-4 weeks of enrollment
  • Increasing or chronic treatment (>5 days) with corticosteroids or another immunosuppressive agent
  • Active heart (cardiac) disease or a history of cardiac dysfunction as defined in the protocol
  • Hypersensitivity to fulvestrant treatment excipients
  • Certain scores on an anxiety and depression mood questionnaire given at screening
  • Other protocol defined criteria may apply
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