TriangleNCT01007942 · STUDY IN CONTEXT
Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer
Draft scope assessment: unclear. Attached because the study's own record names HER2 and names HER2 and names HER2 and describes metastatic disease. The study record does not state Low, low, so it may describe a different alteration of the same gene. 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
PFS was defined as the time from the date of randomization to the date of first radiologically documented tumor progression or death from any cause, whichever occurs first. PFS primary analysis performed when 415 events were reached. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
OS was defined as the time from date of randomization to the date of death from any cause. Final OS was conducted when 388 deaths occurred.
ORR was defined as the percentage of participants whose best overall response was either complete response (CR) or partial response (PR) according to RECIST version 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
CBR was defined as the percentage of participants whose best overall response, according to RECIST, was either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; 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 to deterioration of ECOG performance status score was summarized at time of assessment. ECOG (Eastern Cooperative Oncology Group)performance scale is a standard criteria for measuring how treatment of cancer impacts their level of functioning in terms of their ability to care for themselves, daily activity, \& physical ability (walking, working, etc.). Scale score ranges from 0 to 5, 5 being the worst. ECOG 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, e.g., light housework, office work. 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
PRO = patient reported outcomes; Time to deterioration (≥ 10% worsening from baseline), in the global health status of EORTC QLQ-C30 scale was done in the 3 functional scales (emotional, physical, \& social functioning \[EF, PF, \& SF\]). It contains 30 items \& is composed of multi-item scales \& single-item measures. These include 5 functional scales (physical, role, emotional, social \& cognitive functioning), 3 symptom scales (fatigue, pain, nausea, \& vomiting), a global health status/QoL scale, and 6 single items (dyspnea, diarrhea, constipation, anorexia, insomnia \& financial impact). Each of the multi-item scale includes a different set of items - no item occurs in more than 1 scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome. The global health domain score of the QLQ-C30 questionnaire was pre-specified as the primary QoL domain of interest \& disclosed here.
Reported safety
Quality of life and patient-reported measures
EORTC QLQ · PRO: Time to Deterioration in Global Health Status/QoL Domain Score of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) (by at Least 10%)
Score direction: Lower is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-enhertu-b23e8955
- nct id
- NCT01007942
- qol key
- qol-0005
- source section id
- NCT01007942-om-0005
- source outcome index
- 5
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- PRO: Time to Deterioration in Global Health Status/QoL Domain Score of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) (by at Least 10%)
- measure definition
- PRO = patient reported outcomes; Time to deterioration (≥ 10% worsening from baseline), in the global health status of EORTC QLQ-C30 scale was done in the 3 functional scales (emotional, physical, \& social functioning \[EF, PF, \& SF\]). It contains 30 items \& is composed of multi-item scales \& single-item measures. These include 5 functional scales (physical, role, emotional, social \& cognitive functioning), 3 symptom scales (fatigue, pain, nausea, \& vomiting), a global health status/QoL scale, and 6 single items (dyspnea, diarrhea, constipation, anorexia, insomnia \& financial impact). Each of the multi-item scale includes a different set of items - no item occurs in more than 1 scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome. The global health domain score of the QLQ-C30 questionnaire was pre-specified as the primary QoL domain of interest \& disclosed here.
- time frame
- Baseline, until disease progression or death up to about 41 months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 0
- direction quote
- higher number representing a worse
- population note
- The Full Analysis Set (FAS) consisted of all randomized patients.
- 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-enhertu-b23e8955
- nct id
- NCT01007942
- trial label
- Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer
- applicability
- unclear
- applicability note
- Attached because the study's own record names HER2 and names HER2 and names HER2 and describes metastatic disease. The study record does not state Low, low, so it may describe a different alteration of the same gene. 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-enhertu-b23e8955
- nct id
- NCT01007942
- outcome key
- om-0000
- source section id
- NCT01007942-om-0000
- source outcome index
- 0
- endpoint
- Progressive-free Survival (PFS) Per Investigator Assessment
- endpoint definition
- PFS was defined as the time from the date of randomization to the date of first radiologically documented tumor progression or death from any cause, whichever occurs first. PFS primary analysis performed when 415 events were reached. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- time origin
- Every 6 weeks until disease progression or death which ever occurred first up to about 41 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The Full Analysis Set (FAS) consisted of all randomized patients.
- 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-enhertu-b23e8955
- nct id
- NCT01007942
- outcome key
- om-0001
- source section id
- NCT01007942-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival (OS)
- endpoint definition
- OS was defined as the time from date of randomization to the date of death from any cause. Final OS was conducted when 388 deaths occurred.
- time origin
- Every 3 months until death up to 41 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The Full Analysis Set (FAS) consisted of all randomized patients.
- 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-enhertu-b23e8955
- nct id
- NCT01007942
- outcome key
- om-0002
- source section id
- NCT01007942-om-0002
- source outcome index
- 2
- endpoint
- Overall Response Rate (ORR)
- endpoint definition
- ORR was defined as the percentage of participants whose best overall response was either complete response (CR) or partial response (PR) according to RECIST version 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- time origin
- Every 6 weeks until disease progression or death which ever occurred first up to about 41 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The Full Analysis Set (FAS) consisted of all randomized patients.
- 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-enhertu-b23e8955
- nct id
- NCT01007942
- outcome key
- om-0003
- source section id
- NCT01007942-om-0003
- source outcome index
- 3
- endpoint
- Clinical Benefit Rate (CBR)
- endpoint definition
- CBR was defined as the percentage of participants whose best overall response, according to RECIST, was either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; 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
- Every 6 weeks until disease progression or death which ever occurred first up to about 41 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The Full Analysis Set (FAS) consisted of all randomized patients.
- 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-enhertu-b23e8955
- nct id
- NCT01007942
- outcome key
- om-0004
- source section id
- NCT01007942-om-0004
- source outcome index
- 4
- endpoint
- Median Time to Deterioration of the ECOG Performance Status Score
- endpoint definition
- Time to deterioration of ECOG performance status score was summarized at time of assessment. ECOG (Eastern Cooperative Oncology Group)performance scale is a standard criteria for measuring how treatment of cancer impacts their level of functioning in terms of their ability to care for themselves, daily activity, \& physical ability (walking, working, etc.). Scale score ranges from 0 to 5, 5 being the worst. ECOG 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, e.g., light housework, office work. 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
- time origin
- baseline, until disease progression or death up to about 41 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The Full Analysis Set (FAS) consisted of all randomized patients.
- 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-enhertu-b23e8955
- nct id
- NCT01007942
- outcome key
- om-0005
- source section id
- NCT01007942-om-0005
- source outcome index
- 5
- endpoint
- PRO: Time to Deterioration in Global Health Status/QoL Domain Score of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) (by at Least 10%)
- endpoint definition
- PRO = patient reported outcomes; Time to deterioration (≥ 10% worsening from baseline), in the global health status of EORTC QLQ-C30 scale was done in the 3 functional scales (emotional, physical, \& social functioning \[EF, PF, \& SF\]). It contains 30 items \& is composed of multi-item scales \& single-item measures. These include 5 functional scales (physical, role, emotional, social \& cognitive functioning), 3 symptom scales (fatigue, pain, nausea, \& vomiting), a global health status/QoL scale, and 6 single items (dyspnea, diarrhea, constipation, anorexia, insomnia \& financial impact). Each of the multi-item scale includes a different set of items - no item occurs in more than 1 scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome. The global health domain score of the QLQ-C30 questionnaire was pre-specified as the primary QoL domain of interest \& disclosed here.
- time origin
- Baseline, until disease progression or death up to about 41 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The Full Analysis Set (FAS) consisted of all randomized patients.
- 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-enhertu-b23e8955
- nct id
- NCT01007942
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Everolimus + Vinorelbine + Trastuzumab
- regimen
- Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
- analyzed count
- 284
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01007942-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-enhertu-b23e8955
- nct id
- NCT01007942
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Placebo + Vinorelbine + Trastuzumab
- regimen
- Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
- analyzed count
- 285
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01007942-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-enhertu-b23e8955
- nct id
- NCT01007942
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Everolimus + Vinorelbine + Trastuzumab
- regimen
- Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
- analyzed count
- 284
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01007942-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-enhertu-b23e8955
- nct id
- NCT01007942
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Placebo + Vinorelbine + Trastuzumab
- regimen
- Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
- analyzed count
- 285
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01007942-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-enhertu-b23e8955
- nct id
- NCT01007942
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Everolimus + Vinorelbine + Trastuzumab
- regimen
- Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
- analyzed count
- 284
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01007942-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-enhertu-b23e8955
- nct id
- NCT01007942
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Placebo + Vinorelbine + Trastuzumab
- regimen
- Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
- analyzed count
- 285
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01007942-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-enhertu-b23e8955
- nct id
- NCT01007942
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Everolimus + Vinorelbine + Trastuzumab
- regimen
- Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
- analyzed count
- 284
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01007942-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-enhertu-b23e8955
- nct id
- NCT01007942
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Placebo + Vinorelbine + Trastuzumab
- regimen
- Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
- analyzed count
- 285
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01007942-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-enhertu-b23e8955
- nct id
- NCT01007942
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Everolimus + Vinorelbine + Trastuzumab
- regimen
- Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
- analyzed count
- 284
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01007942-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-enhertu-b23e8955
- nct id
- NCT01007942
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Placebo + Vinorelbine + Trastuzumab
- regimen
- Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
- analyzed count
- 285
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01007942-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-enhertu-b23e8955
- nct id
- NCT01007942
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Everolimus + Vinorelbine + Trastuzumab
- regimen
- Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
- analyzed count
- 284
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01007942-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-enhertu-b23e8955
- nct id
- NCT01007942
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Placebo + Vinorelbine + Trastuzumab
- regimen
- Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
- analyzed count
- 285
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01007942-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-breast-cancer-enhertu-b23e8955
- nct id
- NCT01007942
- harm key
- EG000
- source section id
- NCT01007942-ae
- event group key
- EG000
- event group label
- Everolimus + Trastuzumab + Vinorelbine
- serious affected
- 122
- serious at risk
- 280
- other affected
- 280
- other at risk
- 280
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Source null
- 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-enhertu-b23e8955
- nct id
- NCT01007942
- harm key
- EG001
- source section id
- NCT01007942-ae
- event group key
- EG001
- event group label
- Placebo + Trastuzumab + Vinorelbine
- serious affected
- 58
- serious at risk
- 282
- other affected
- 280
- other at risk
- 282
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Source null
- 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-enhertu-b23e8955
- nct id
- NCT01007942
- qol key
- qol-0005
- source section id
- NCT01007942-om-0005
- source outcome index
- 5
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- PRO: Time to Deterioration in Global Health Status/QoL Domain Score of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) (by at Least 10%)
- measure definition
- PRO = patient reported outcomes; Time to deterioration (≥ 10% worsening from baseline), in the global health status of EORTC QLQ-C30 scale was done in the 3 functional scales (emotional, physical, \& social functioning \[EF, PF, \& SF\]). It contains 30 items \& is composed of multi-item scales \& single-item measures. These include 5 functional scales (physical, role, emotional, social \& cognitive functioning), 3 symptom scales (fatigue, pain, nausea, \& vomiting), a global health status/QoL scale, and 6 single items (dyspnea, diarrhea, constipation, anorexia, insomnia \& financial impact). Each of the multi-item scale includes a different set of items - no item occurs in more than 1 scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome. The global health domain score of the QLQ-C30 questionnaire was pre-specified as the primary QoL domain of interest \& disclosed here.
- time frame
- Baseline, until disease progression or death up to about 41 months
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 0
- direction quote
- higher number representing a worse
- population note
- The Full Analysis Set (FAS) consisted of all randomized patients.
- 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