TriangleNCT00863655 · STUDY IN CONTEXT
Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory t
Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
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.
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.
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) 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.
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.
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.
Reported safety
Quality of life and patient-reported measures
EORTC QLQ · Patient-reported Outcomes (PROs): Time to Deterioration of PRO Scores Using Kaplan Meier - EORTC QLQ-C30
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00863655
- qol key
- qol-0006
- source section id
- NCT00863655-om-0006
- source outcome index
- 6
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Patient-reported Outcomes (PROs): Time to Deterioration of PRO Scores Using Kaplan Meier - EORTC QLQ-C30
- measure definition
- 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.
- time frame
- Up to 21 months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- All randomized patients were included in the Full Analysis Set.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00863655
- trial label
- Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory t
- applicability
- unclear
- applicability note
- Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 1
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00863655
- outcome key
- om-0000
- source section id
- NCT00863655-om-0000
- source outcome index
- 0
- endpoint
- Progression-free Survival (PFS) Based on Local Radiology Review of Tumor Assessments.
- endpoint definition
- 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.
- time origin
- 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
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized patients were included in the Full Analysis Set.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00863655
- outcome key
- om-0001
- source section id
- NCT00863655-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival (OS) by Number of Deaths
- endpoint definition
- 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.
- time origin
- up to 53 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized patients were included in the Full Analysis Set.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00863655
- outcome key
- om-0002
- source section id
- NCT00863655-om-0002
- source outcome index
- 2
- endpoint
- Overall Survival (OS) by Median
- endpoint definition
- 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.
- time origin
- up to 53 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized patients were included in the Full Analysis Set.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00863655
- outcome key
- om-0003
- source section id
- NCT00863655-om-0003
- source outcome index
- 3
- endpoint
- Overall Response Rate (ORR)
- endpoint definition
- 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.
- time origin
- up to 21 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized patients were included in the Full Analysis Set.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00863655
- outcome key
- om-0004
- source section id
- NCT00863655-om-0004
- source outcome index
- 4
- endpoint
- Clinical Benefit Rate (CBR)
- endpoint definition
- 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.
- time origin
- up to 21 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized patients were included in the Full Analysis Set.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00863655
- outcome key
- om-0005
- source section id
- NCT00863655-om-0005
- source outcome index
- 5
- endpoint
- Proportion of Patients With no Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Using Kaplan-Meier
- endpoint definition
- 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.
- time origin
- 2, 4, 6, 9 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized patients were included in the Full Analysis Set.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00863655
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Everolimus + Exemestane
- regimen
- Everolimus 10 mg daily in combination with exemestane 25 mg daily
- analyzed count
- 485
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00863655-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00863655
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Placebo + Exemestane
- regimen
- Placebo of everolimus in combination with exemestane 25 mg daily
- analyzed count
- 239
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00863655-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00863655
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Everolimus + Exemestane
- regimen
- Everolimus 10 mg daily in combination with exemestane 25 mg daily
- analyzed count
- 485
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00863655-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00863655
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Placebo + Exemestane
- regimen
- Placebo of everolimus in combination with exemestane 25 mg daily
- analyzed count
- 239
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00863655-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00863655
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Everolimus + Exemestane
- regimen
- Everolimus 10 mg daily in combination with exemestane 25 mg daily
- analyzed count
- 485
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00863655-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00863655
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Placebo + Exemestane
- regimen
- Placebo of everolimus in combination with exemestane 25 mg daily
- analyzed count
- 239
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00863655-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00863655
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Everolimus + Exemestane
- regimen
- Everolimus 10 mg daily in combination with exemestane 25 mg daily
- analyzed count
- 485
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00863655-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00863655
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Placebo + Exemestane
- regimen
- Placebo of everolimus in combination with exemestane 25 mg daily
- analyzed count
- 239
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00863655-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00863655
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Everolimus + Exemestane
- regimen
- Everolimus 10 mg daily in combination with exemestane 25 mg daily
- analyzed count
- 485
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00863655-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00863655
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Placebo + Exemestane
- regimen
- Placebo of everolimus in combination with exemestane 25 mg daily
- analyzed count
- 239
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00863655-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00863655
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Everolimus + Exemestane
- regimen
- Everolimus 10 mg daily in combination with exemestane 25 mg daily
- analyzed count
- 485
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00863655-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00863655
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Placebo + Exemestane
- regimen
- Placebo of everolimus in combination with exemestane 25 mg daily
- analyzed count
- 239
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00863655-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00863655
- harm key
- EG000
- source section id
- NCT00863655-ae
- event group key
- EG000
- event group label
- Everolimus + Exemestane
- serious affected
- 158
- serious at risk
- 482
- other affected
- 479
- other at risk
- 482
- frequency threshold
- 5
- collection period
- Source null
- event definition
- 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00863655
- harm key
- EG001
- source section id
- NCT00863655-ae
- event group key
- EG001
- event group label
- Placebo + Exemestane
- serious affected
- 37
- serious at risk
- 238
- other affected
- 209
- other at risk
- 238
- frequency threshold
- 5
- collection period
- Source null
- event definition
- 4 patients were excluded from the Safety Set; all 4 of these patients (3 in the everolimus plus exemestane arm and 1 in the placebo plus exemestane group) were randomized but subsequently didn't receive study treatment and didn't have an AE reported.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-paclitaxel-protein-bound-particles-albumin-bound-0d516855
- nct id
- NCT00863655
- qol key
- qol-0006
- source section id
- NCT00863655-om-0006
- source outcome index
- 6
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Patient-reported Outcomes (PROs): Time to Deterioration of PRO Scores Using Kaplan Meier - EORTC QLQ-C30
- measure definition
- 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.
- time frame
- Up to 21 months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- All randomized patients were included in the Full Analysis Set.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice