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 | |||||
| Website | http://www.boogstudycenter.nl | ||||
| Sponsor | Novartis | ||||
| Principal Investigator(s) | C.H. Smorenburg | |||
| Study manager | ||||
| Central datamanagement and randomization | ||||
| Monitoring | Novartis | |||
| Local datamanagement | ||||
| Funding | ||||
| Extra | ||||
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
Main eligibility criteria:
Postmenopausal women with locally advanced or metastatic ER positive breast cancer refractory to non steroidal aromatase inhibitors (NSAIs)
Documents (public):
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