BOLERO 2

BOOG 2009-05

General Information

BOOG number

BOOG 2009-05

Nickname

BOLERO 2

Status

Date: 28/12/2010

Other study number

CRAD001Y2301

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

Indication

Subindication

HER2- HR+

Target sample size

705

Actual accrual

653 (NL:18)
Date: 14/12/2010

Estimated study completion date

28/12/2010

Contact

Sponsor

Novartis

Principal Investigator(s)

C.H. Smorenburg

Monitoring

Novartis

Design

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

Objectives

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).

Endpoints

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

Eligibility Criteria

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

Regulatory Information

CCMO approval

Yes

EC

METC Noord-Holland

EudraCT number

2008-008698-69

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