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
CompletedPhase 3Results postedLast updated 2 May 2017
What this trial tests
Phase 3 trial testing Everolimus in Breast Cancer in 724 participants. Completed in 4 December 2014.
18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessments.Primary· 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 up to about 19 months
Progression-free survival, the primary endpoint in this study, is defined as the time from the date of randomization to the date of first documented radiological progression or death due to any cause. Disease progression was based on the tumor assessment by the local radiologist or investigator using RECIST 1.0 criteria. If a patient did not progress or known to have died at the date of the analysis cut-off or start of another antineoplastic therapy, the PFS date was censored to the date of last adequate tumor assessment prior to cut-off date or start of antineoplastic therapy. For patients wi
Group
Value
95% CI
Everolimus + Exemestane
6.93
6.44 – 8.05
Placebo + Exemestane
2.83
2.76 – 4.14
Overall Survival (OS) by Number of DeathsSecondary· up to 53 months
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. If a patient is not known to have died, survival was censored at the date of last contact.
Group
Value
95% CI
Everolimus + Exemestane
267
Placebo + Exemestane
143
Overall Survival (OS) by MedianSecondary· up to 53 months
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.
Group
Value
95% CI
Everolimus + Exemestane
30.98
27.96 – 34.56
Placebo + Exemestane
26.55
22.57 – 33.08
Overall Response Rate (ORR)Secondary· up to 21 months
Overall response rate (ORR) is the percentage of patients with a best overall response of complete response (CR) or partial response (PR) according to RECIST 1.0. Per RECIST criteria 1.0, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.
Group
Value
95% CI
Everolimus + Exemestane
9.5
Placebo + Exemestane
0.4
Clinical Benefit Rate (CBR)Secondary· up to 21 months
CBR is defined as the percentage of patients with best overall response of either complete response (CR), a partial response (PR) or stable disease (SD) \>= 24 weeks, according to RECIST 1.0. Per RECIST criteria 1.0, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; PD = At least a 20% increase in the sum of the longest diameter of all measured
Group
Value
95% CI
Everolimus + Exemestane
33.4
Placebo + Exemestane
18.0
Proportion of Patients With no Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Using Kaplan-MeierSecondary· 2, 4, 6, 9 months
The ECOG PS (Eastern Cooperative Oncology Group Performance Scale) is a standard criteria for measuring how treatment of cancer impacts level of functioning in terms of the ability to care for oneself, daily activity, \& physical ability (walking, working, etc.). Scale score ranges:0 to 5, 5 being the worst. Scale index: 0: Fully active, able to carry on all pre-disease performance without restriction. 1: Restricted in physically strenuous activity but ambulatory \& able to carry out work of a light or sedentary nature. 2: Ambulatory \& capable of all self-care but unable to carry out any work
2 Months
Group
Value
95% CI
Everolimus + Exemestane
0.84
0.80 – 0.87
Placebo + Exemestane
0.87
0.82 – 0.91
4 Months
Group
Value
95% CI
Everolimus + Exemestane
0.74
0.70 – 0.78
Placebo + Exemestane
0.80
0.73 – 0.85
6 Months
Group
Value
95% CI
Everolimus + Exemestane
0.64
0.58 – 0.69
Placebo + Exemestane
0.67
0.57 – 0.75
9 Months
Group
Value
95% CI
Everolimus + Exemestane
0.57
0.50 – 0.63
Placebo + Exemestane
0.47
0.32 – 0.61
Patient-reported Outcomes (PROs): Time to Deterioration of PRO Scores Using Kaplan Meier - EORTC QLQ-C30Secondary· Up to 21 months
The QLQ-C30 is composed of both multi-item scales and single-item measures. These include 5 functional scales, 3 symptom scales, a global health status - QoL scale, and 6 single items. Each of the multi-item scales includes a different set of items - no item occurs in more than 1 scale. All of the scales measures range in score from 0 to 100. A high scale score = higher response level. Thus a high score for a functional scale represents a healthy level of function, a high score for the global health status / QoL represents a high quality of life but a high score for a symptom scale / item repr
Deterioration global health status score ≥ 5%
Group
Value
95% CI
Everolimus + Exemestane
4.53
4.17 – 5.68
Placebo + Exemestane
4.40
3.58 – 5.85
Deterioration in PF domain score of ≥ 5%
Group
Value
95% CI
Everolimus + Exemestane
4.83
4.17 – 6.97
Placebo + Exemestane
4.37
2.83 – 7.00
Deterioration in EF domain score of ≥ 5%
Group
Value
95% CI
Everolimus + Exemestane
6.93
5.55 – 8.41
Placebo + Exemestane
6.93
4.17 – 7.36
Deterioration in SF domain score of ≥ 5%
Group
Value
95% CI
Everolimus + Exemestane
8.34
6.93 – 10.87
Placebo + Exemestane
7.03
5.62 – NA
Proportion of Patients With Having no Overall Response Based on Investigator AssessmentSecondary· 2, 4, 6, 9 months
overall response = complete response (CR) + partial response (PR) per RECIST 1.0 Time to overall response (CR or PR) based on investigator is the time between date of randomization/start of treatment until first documented response (CR or PR). This analysis included all patients/responders. Patients who did not achieve a confirmed PR or CR were censored at last adequate tumor assessment date when they did not progress. Per RECIST criteria 1.0, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the b
2 months
Group
Value
95% CI
Everolimus + Exemestane
0.96
0.94 – 0.98
Placebo + Exemestane
1.00
0.97 – 1.00
4 months
Group
Value
95% CI
Everolimus + Exemestane
0.93
0.91 – 0.95
Placebo + Exemestane
1.00
0.97 – 1.00
6 months
Group
Value
95% CI
Everolimus + Exemestane
0.92
0.89 – 0.94
Placebo + Exemestane
1.00
0.97 – 1.00
9 months
Group
Value
95% CI
Everolimus + Exemestane
0.90
0.88 – 0.93
Placebo + Exemestane
1.00
0.97 – 1.00
Duration of Response (Among Participants With Best Overall Response of CR or PR) Estimated Per Kaplan-MeierSecondary· 21 months
Duration of response of CR or PR based on investigator applies only to patients whose best overall response was CR or PR (RECIST 1.0). The start date was the date of first documented response (CR or PR) and the end date and censoring is defined the same as that for time to progression. Per RECIST criteria 1.0, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.
Group
Value
95% CI
Everolimus + Exemestane
8.21
5.55 – NA
Placebo + Exemestane
NA
NA – NA
Everolimus Concentrations at Week 4Secondary· pre-dose, 2 hours post-dose
Characterize the pharmacokinetics (PK) of everolimus in combination with exemestane using Cmin (pre-dose) and C2h (post-dose) at week 4 in a small group of patients.
Pre-dose (Cmin) (n:22)
Group
Value
95% CI
Everolimus + Exemestane
16.04
± 9.356
2 hours post-dose (C2h) (n:24)
Group
Value
95% CI
Everolimus + Exemestane
46.50
± 17.954
Exemestane Concentrations at Week 4Secondary· predose, 2 hours post-dose
Characterize the PK of exemestane in combination with or without everolimus using Cmin and C2h at week 4 in a small group of patients.
There are no treatments specifically approved after recurrence or progression on a non steroidal aromatase inhibitors (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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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NCT07477548 — A Study to Evaluate the Efficacy and Safety of Everolimus in Patients With Teratment-refractory Vascular Anomalies
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NCT07405164 — Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)
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NCT06832189 — EVR and EPO for Liver Transplant Tolerance
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 2 May 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00863655.