Trial · NCT00863655
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
NCT00863655, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2012-08-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT00863655. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00863655
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT00863655
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 724 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Breast Cancer
- Interventions
- Everolimus, Exemestane, Everolimus Placebo
- First posted
- 2009-03-18
- Last updated
- 2017-05-02
- Other registries' IDs
- eudract:2008-008698-69
- Results first posted
- 2012-08-31
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessments. | 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 with lytic or mixed (lytic+sclerotic) bone lesions, the following is considered progression: appearance of ≥1 new lytic lesions in bone; the appearance of ≥ new lesions outside of bone and unequivocal progression of existing bone lesions. |
| Secondary | Overall Survival (OS) by Number of Deaths | 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. |
| Secondary | Overall Survival (OS) by Median | 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. |
| Secondary | Overall Response Rate (ORR) | 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. |
| Secondary | Clinical Benefit Rate (CBR) | 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 target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline. |
| Secondary | Proportion of Patients With no Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Using Kaplan-Meier | 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 activities. Up \& about more than 50% of waking hours. 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 - Dead. A deterioration of ECOG is an increase of 1 of the ECOG PS without improvement back to initial level at a subsequent time of measurement. |
| Secondary | Patient-reported Outcomes (PROs): Time to Deterioration of PRO Scores Using Kaplan Meier - EORTC QLQ-C30 | 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 represents a high level of symptomatology / problems. The principle for scoring these scales: 1.) Estimate the average of the items that contribute to the scale = raw score. 2.) Linear transformation to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms. |
| Secondary | Proportion of Patients With Having no Overall Response Based on Investigator Assessment | 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 baseline sum of the longest diameters. |
| Secondary | Duration of Response (Among Participants With Best Overall Response of CR or PR) Estimated Per Kaplan-Meier | 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. |
| Secondary | Everolimus Concentrations at Week 4 | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessments. | 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 | All randomized patients were included in the Full Analysis Set. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) by Number of Deaths | up to 53 months | All randomized patients were included in the Full Analysis Set. | Participants | NUMBER |
| SECONDARY | Overall Survival (OS) by Median | up to 53 months | All randomized patients were included in the Full Analysis Set. | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) | up to 21 months | All randomized patients were included in the Full Analysis Set. | Percentage of participants | NUMBER |
| SECONDARY | Clinical Benefit Rate (CBR) | up to 21 months | All randomized patients were included in the Full Analysis Set. | Percentage of participants | NUMBER |
| SECONDARY | Proportion of Patients With no Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Using Kaplan-Meier | 2, 4, 6, 9 months | All randomized patients were included in the Full Analysis Set. | Proportion of patients | NUMBER |
| SECONDARY | Patient-reported Outcomes (PROs): Time to Deterioration of PRO Scores Using Kaplan Meier - EORTC QLQ-C30 | Up to 21 months | All randomized patients were included in the Full Analysis Set. | Months | MEDIAN |
| SECONDARY | Proportion of Patients With Having no Overall Response Based on Investigator Assessment | 2, 4, 6, 9 months | All randomized patients were included in the Full Analysis Set. | Proportion of patients | NUMBER |
| SECONDARY | Duration of Response (Among Participants With Best Overall Response of CR or PR) Estimated Per Kaplan-Meier | 21 months | Randomized patients with best overall response of CR or PR. | Months | MEDIAN |
| SECONDARY | Everolimus Concentrations at Week 4 | pre-dose, 2 hours post-dose | Safety Set population consisted of all patients who received at least one dose of study treatment and who had at least one valid post-baseline safety assessment. Although the safety set was considered for the analysis (N), only participants (n) who had pre-dose \& 2 hours post-dose values for the given time points were analyzed for that time point. | ng/mL | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessments. | Everolimus + Exemestane | 6.93 | 95% Confidence Interval 6.44 to 8.05 | months | |
| Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessments. | Placebo + Exemestane | 2.83 | 95% Confidence Interval 2.76 to 4.14 | months | |
| Overall Survival (OS) by Number of Deaths | Everolimus + Exemestane | 267 | Participants | ||
| Overall Survival (OS) by Number of Deaths | Placebo + Exemestane | 143 | Participants | ||
| Overall Survival (OS) by Median | Everolimus + Exemestane | 30.98 | 95% Confidence Interval 27.96 to 34.56 | Months | |
| Overall Survival (OS) by Median | Placebo + Exemestane | 26.55 | 95% Confidence Interval 22.57 to 33.08 | Months | |
| Overall Response Rate (ORR) | Everolimus + Exemestane | 9.5 | Percentage of participants | ||
| Overall Response Rate (ORR) | Placebo + Exemestane | 0.4 | Percentage of participants | ||
| Clinical Benefit Rate (CBR) | Everolimus + Exemestane | 33.4 | Percentage of participants | ||
| Clinical Benefit Rate (CBR) | Placebo + Exemestane | 18.0 | Percentage of participants |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Everolimus + Exemestane | 485 | |
| Overall Study | STARTED | Placebo + Exemestane | 239 | |
| Overall Study | COMPLETED | Everolimus + Exemestane | 0 | |
| Overall Study | COMPLETED | Placebo + Exemestane | 0 | |
| Overall Study | NOT COMPLETED | Everolimus + Exemestane | 485 | |
| Overall Study | NOT COMPLETED | Placebo + Exemestane | 239 |
Source ClinicalTrials.gov
Adverse events970
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Everolimus + Exemestane | 93 | 482 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Exemestane | 9 | 238 | |
| other | Leukopenia | Blood and lymphatic system disorders | Everolimus + Exemestane | 27 | 482 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo + Exemestane | 3 | 238 | |
| other | Neutropenia | Blood and lymphatic system disorders | Everolimus + Exemestane | 39 | 482 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo + Exemestane | 3 | 238 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Everolimus + Exemestane | 61 | 482 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo + Exemestane | 1 | 238 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Everolimus + Exemestane | 34 | 482 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo + Exemestane | 7 | 238 |
1 to 10 of 970Source ClinicalTrials.gov
See all 970 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Everolimus + Exemestane | ||
| Total, all-cause mortality | Placebo + Exemestane | ||
| Total, other adverse events | Everolimus + Exemestane | 479 | 482 |
| Total, other adverse events | Placebo + Exemestane | 209 | 238 |
| Total, serious adverse events | Everolimus + Exemestane | 158 | 482 |
| Total, serious adverse events | Placebo + Exemestane | 37 | 238 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Everolimus + Exemestane vs Placebo + Exemestane: Overall Survival (OS) by Number of Deaths | Trial comparisons |
| Everolimus + Exemestane vs Placebo + Exemestane: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00863655
GET https://conductscience.org/api/trials/v1/NCT00863655/results?page=2