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 (BOLERO 2)
There are no treatments specifically approved after recurrence or progression on a NSAI. In light of the need for new treatment options for postmenopausal women after failure of prior NSAI therapy, the purpose of this Phase III study is to compare efficacy and safety of a treatment with exemestane + everolimus to exemestane + placebo in postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer refractory to NSAI.
Drug: Everolimus, Exemestane
Drug: Placebo, Exemestane
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official 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|
- Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessments. [ Time Frame: date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first ,reported between day of first patient randomized, 27 July 2009, until cut-off date 11 February 2011. ] [ Designated as safety issue: No ]Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST 1.0). For patients with no target lesion, in the absence of new lesions, the overall lesion response at each assessment was one of following: Complete Response CR), Stable Disease SD), Unknown, or Progressive Disease (PD) based on non-target lesion responses. The following is considered progression among patients with lytic or mixed (lytic+sclerotic) bone lesions: appearance of ≥1 new lytic lesions in bone; the appearance of ≥ new lesions outside of bone and unequivocal progression of existing bone lesions.
- Overall Survival (OS) [ Time Frame: Every 3 months after End of Treatment + 28 days (every 6 weeks before) ] [ Designated as safety issue: No ]Overall survival, the key secondary endpoint in this study, is defined as the time from date of randomization to the date of death due to any cause.
- Overall Response Rate (ORR) [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]ORR is defined as the proportion of patients whose best overall response is either complete response (CR) or partial response (PR) according to RECIST.
- Incidence of Adverse Events (AEs)/Serious Adverse Events (SAEs) [ Time Frame: Continuous and every 6 weeks ] [ Designated as safety issue: Yes ]In addition to AEs/SAEs, shift from baseline in vital signs and laboratory results (hematology, blood chemistry) will be reported.
- Qol Scores ECOG Performance Status [ Time Frame: Every 6 weeks ] [ Designated as safety issue: Yes ]Change in QoL scores over time and time to deterioration of ECOG performance status.
- Clinical Benefit Rate (CBR) [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]CBR is defined as the proportion of patients whose best overall response is either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks, according to RECIST.
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Everolimus + Exemestane
Everolimus 10 mg daily in combination with exemestane 25 mg daily
Drug: Everolimus, Exemestane
Other Name: RAD001
Active Comparator: Placebo + Exemestane
Placebo of everolimus in combination with exemestane 25 mg daily
|Drug: Placebo, Exemestane|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00863655
Show 201 Study Locations
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|
|Study Director:||Novartis Pharmaceuticlas||Novartis Pharmaceuticals|