Studieoverzicht - 2009-05 BOLERO 2

Number 2009-05 BOLERO 2
Nickname BOLERO 2
Status Closed Date: 28-12-2010
Inclusion closed
Other study number(s) CRAD001Y2301
Participating parties/groups
Full title A Randomized Double-Blind, Placebo-Controlled Study of Everolimus in Combination with Exemestane in the Treatment of Postmenopausal Women with Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer who are refractory to Letrozole or anastrozole
Phase and type Double-Blind, Placebo-Controlled
Age ≥ 18
Menopausal status Postmenopausal
Indication Advanced/metastatic
Subindication HER2- HR+
Target sample size 705
Actual accrual 653 (NL:18) Date: 14-12-2010
Estimated study completion date 28-12-2010
CCMO approval Not applicable Date: Nr:
EudraCT nr. 2008-008698-69
Trial Register
METC approval Date: 30-07-2009 METC: METC Noord-Holland Nr:
Amendments Date:
KWF-CKS approval Not applicable Date: Nr:
News item
Sponsor Novartis
Principal Investigator(s) C.H. Smorenburg
Study manager
Central datamanagement and randomization
Monitoring Novartis
Local datamanagement


Randomization in 2:1 ratio:
Arm A: Exemestane 25 mg/day p.o. + everolimus 5 mg x 2/day p.o.
Arm B: Exemestane 25 mg/day p.o. + placebo x 2/day p.o


To compare the combination treatment of everolimus and exemestane to exemestane alone with respect to progression-free survival in postmenopausal women with estrogen receptor positive breast cancer that is refractory to non steroidal aromatase inhibitors(NSAIs).


Primary endpoint:

  • Progression-free survival

Secondary endpoints:

  • Overall survival
  • Overall response rate
  • Time to deterioration of ECOG erformance Status
  • Safety
  • Change in QoL scores over time
  • Clinical benefit rate
  • Time to response 
  • Duration of response
Main eligibility criteria:

Postmenopausal women with locally advanced or metastatic ER positive breast cancer refractory to non steroidal aromatase inhibitors (NSAIs)

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