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← SOLTAMOX: metastatic Breast cancer

NCT01602380 · STUDY IN CONTEXT

A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer.

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

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

PFS was defined as the time from randomisation until objective disease progression according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1), surgery or radiotherapy to manage worsening of disease or death by any cause (in the absence of progression). Outcome measure is reported as median time from randomisation to PFS, calculated using the Kaplan-Meier technique.

The ITT analysis set included all randomised patients.

→

secondary · POSTED

OS was defined as the time from randomisation until death by any cause. The current OS data correspond to that of the final analysis and the outcome measure is reported as percentage of patients with events.

The ITT analysis set included all randomised patients. Date of death of 2 participants were unknown in the Anastrozole 1mg arm, hence they were censored for OS analysis.

→

secondary · POSTED

ORR was defined as the percentage patients with an objective response (i.e. those recording a partial response \[PR\] or complete response \[CR\]) at some point during the study, prior to disease progression. ORR was assessed in patients with measurable disease at baseline only. The determination of measurable disease at baseline was done using baseline RECIST data. CR was disappearance of all target lesions since baseline; was any pathological lymph nodes selected as target lesions (TL) to have a reduction in short axis to \<10 millimeter. PR was at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.

Percentages for ORR were calculated based on the number of patients in the ITT analysis set (which included all randomised patients) who had measurable disease at baseline (n=193 for Fulvestrant arm and n=196 for Anastrozole arm).

→

secondary · POSTED

DoR was defined only for patients who had an objective response, as the time in days from date of first documentation of response (CR/PR) until date of disease progression. CR was disappearance of all target lesions since baseline; any pathological lymph nodes selected as TL to have a reduction in short axis to \<10 mm. At least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.

Only patients in the ITT analysis set (which included all randomised patients), who also had an objective response and had measurable disease at baseline were included in the DoR analysis (n=89 for Fulvestrant arm and n=88 for Anastrozole arm).

→

secondary · POSTED

EDoR was estimated using the formula EDoR = p Efp(x), where x = DoR, p = proportion of responders, and Efp(x) = mean duration of response for responders. The estimation was completed by using the maximum likelihood estimates of p and Efp(x), as described by Ellis (Ellis S et al. Analysis of duration of response in oncology trials, Contemp Clin Trials 2008; 29:456-65).

EDoR analysis was based on the number of patients in the ITT analysis set (which included all randomised patients) who had measurable disease at baseline (n=193 for Fulvestrant arm and n=196 for Anastrozole arm).

→

secondary · POSTED

CBR was defined as the percentage of patients who had a clinical benefit (i.e. best objective response of CR, PR or stable disease), that was maintained for at least 24 weeks, prior to any evidence of progression. Note that a minimum duration of 22 weeks for CBR was applicable in the analysis (rather than 24 weeks) to allow for the protocolled window of +/-2 weeks.

The ITT analysis set included all randomised patients.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

FACT · Comparison of the Effect of Fulvestrant Treatment Versus Anastrozole Treatment on Time to Deterioration of Health-Related Quality of Life (HRQoL)

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-soltamox-0c061d28
nct id
NCT01602380
qol key
qol-0008
source section id
NCT01602380-om-0008
source outcome index
8
instrument
FACT
instrument basis
matched 'fact-b' in the study's own wording
scale title
Comparison of the Effect of Fulvestrant Treatment Versus Anastrozole Treatment on Time to Deterioration of Health-Related Quality of Life (HRQoL)
measure definition
The Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire was the instrument selected to assess HRQoL and comprised of following subscales: physical well-being (PWB), functional well-being (FWB), social well-being, emotional well-being, and breast cancer subscale (BCS). The main outcome measure from the FACT-B questionnaire was the Trial Outcome Index (TOI), which was a summary of the following subscales: PWB, FWB, and BCS. Outcome measure is reported as median time to deterioration, defined as the interval from the date of baseline of final analysis to the first assessment of worsened without an improvement in the next 12 weeks in FACT-B TOI, or the date of death (by any cause in the absence of symptom deterioration). Time to deterioration as measured by FACT-B total score was derived similarly and is also reported.
time frame
Quality of life questionnaires administered at 3 months post objective disease progression, then at 6-monthly intervals (approximately 75 months)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The ITT analysis set included all randomised patients.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-soltamox-0c061d28
nct id
NCT01602380
trial label
A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer.
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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-soltamox-0c061d28
    nct id
    NCT01602380
    outcome key
    om-0000
    source section id
    NCT01602380-om-0000
    source outcome index
    0
    endpoint
    Comparison of Progression-Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole
    endpoint definition
    PFS was defined as the time from randomisation until objective disease progression according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1), surgery or radiotherapy to manage worsening of disease or death by any cause (in the absence of progression). Outcome measure is reported as median time from randomisation to PFS, calculated using the Kaplan-Meier technique.
    time origin
    Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until the earliest of disease progression evident, patient dies or has surgery/radiotherapy for their disease (up to approximately 38 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The ITT analysis set included all randomised patients.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-soltamox-0c061d28
    nct id
    NCT01602380
    outcome key
    om-0001
    source section id
    NCT01602380-om-0001
    source outcome index
    1
    endpoint
    Comparison of Overall Survival (OS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole; Percentage of Patients With Events
    endpoint definition
    OS was defined as the time from randomisation until death by any cause. The current OS data correspond to that of the final analysis and the outcome measure is reported as percentage of patients with events.
    time origin
    Baseline (Day 0) up to data cut-off for final analysis (up to approximately 116 months). Following disease progression, patients were to be contacted at 12 weekly intervals to determine survival status
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The ITT analysis set included all randomised patients. Date of death of 2 participants were unknown in the Anastrozole 1mg arm, hence they were censored for OS analysis.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-soltamox-0c061d28
    nct id
    NCT01602380
    outcome key
    om-0002
    source section id
    NCT01602380-om-0002
    source outcome index
    2
    endpoint
    Objective Response Rate (ORR) for Fulvestrant Treatment Versus Anastrozole Treatment
    endpoint definition
    ORR was defined as the percentage patients with an objective response (i.e. those recording a partial response \[PR\] or complete response \[CR\]) at some point during the study, prior to disease progression. ORR was assessed in patients with measurable disease at baseline only. The determination of measurable disease at baseline was done using baseline RECIST data. CR was disappearance of all target lesions since baseline; was any pathological lymph nodes selected as target lesions (TL) to have a reduction in short axis to \<10 millimeter. PR was at least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.
    time origin
    Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Percentages for ORR were calculated based on the number of patients in the ITT analysis set (which included all randomised patients) who had measurable disease at baseline (n=193 for Fulvestrant arm and n=196 for Anastrozole arm).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-soltamox-0c061d28
    nct id
    NCT01602380
    outcome key
    om-0003
    source section id
    NCT01602380-om-0003
    source outcome index
    3
    endpoint
    Duration of Response (DoR) for Fulvestrant Treatment Versus Anastrozole Treatment
    endpoint definition
    DoR was defined only for patients who had an objective response, as the time in days from date of first documentation of response (CR/PR) until date of disease progression. CR was disappearance of all target lesions since baseline; any pathological lymph nodes selected as TL to have a reduction in short axis to \<10 mm. At least a 30% decrease in the sum of the diameters of TL, taking as reference the baseline sum of diameters.
    time origin
    Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Only patients in the ITT analysis set (which included all randomised patients), who also had an objective response and had measurable disease at baseline were included in the DoR analysis (n=89 for Fulvestrant arm and n=88 for Anastrozole arm).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-soltamox-0c061d28
    nct id
    NCT01602380
    outcome key
    om-0004
    source section id
    NCT01602380-om-0004
    source outcome index
    4
    endpoint
    Expected Duration of Response (EDoR) for Fulvestrant Treatment Versus Anastrozole Treatment
    endpoint definition
    EDoR was estimated using the formula EDoR = p Efp(x), where x = DoR, p = proportion of responders, and Efp(x) = mean duration of response for responders. The estimation was completed by using the maximum likelihood estimates of p and Efp(x), as described by Ellis (Ellis S et al. Analysis of duration of response in oncology trials, Contemp Clin Trials 2008; 29:456-65).
    time origin
    Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    EDoR analysis was based on the number of patients in the ITT analysis set (which included all randomised patients) who had measurable disease at baseline (n=193 for Fulvestrant arm and n=196 for Anastrozole arm).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-soltamox-0c061d28
    nct id
    NCT01602380
    outcome key
    om-0005
    source section id
    NCT01602380-om-0005
    source outcome index
    5
    endpoint
    Clinical Benefit Rate (CBR) for Fulvestrant Treatment Versus Anastrozole Treatment
    endpoint definition
    CBR was defined as the percentage of patients who had a clinical benefit (i.e. best objective response of CR, PR or stable disease), that was maintained for at least 24 weeks, prior to any evidence of progression. Note that a minimum duration of 22 weeks for CBR was applicable in the analysis (rather than 24 weeks) to allow for the protocolled window of +/-2 weeks.
    time origin
    Baseline RECIST 1.1 assessments (Day 0) and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The ITT analysis set included all randomised patients.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-soltamox-0c061d28
    nct id
    NCT01602380
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Fulvestrant 500 mg
    regimen
    Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
    analyzed count
    230
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01602380-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-soltamox-0c061d28
    nct id
    NCT01602380
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Anastrozole 1 mg
    regimen
    Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).
    analyzed count
    232
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01602380-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-soltamox-0c061d28
    nct id
    NCT01602380
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Fulvestrant 500 mg
    regimen
    Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
    analyzed count
    230
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01602380-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-soltamox-0c061d28
    nct id
    NCT01602380
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Anastrozole 1 mg
    regimen
    Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).
    analyzed count
    232
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01602380-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-soltamox-0c061d28
    nct id
    NCT01602380
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Fulvestrant 500 mg
    regimen
    Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
    analyzed count
    193
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01602380-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-soltamox-0c061d28
    nct id
    NCT01602380
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Anastrozole 1 mg
    regimen
    Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).
    analyzed count
    196
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01602380-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-soltamox-0c061d28
    nct id
    NCT01602380
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Fulvestrant 500 mg
    regimen
    Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
    analyzed count
    89
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01602380-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-soltamox-0c061d28
    nct id
    NCT01602380
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Anastrozole 1 mg
    regimen
    Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).
    analyzed count
    88
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01602380-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-soltamox-0c061d28
    nct id
    NCT01602380
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Fulvestrant 500 mg
    regimen
    Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
    analyzed count
    193
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01602380-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-soltamox-0c061d28
    nct id
    NCT01602380
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Anastrozole 1 mg
    regimen
    Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).
    analyzed count
    196
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01602380-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-soltamox-0c061d28
    nct id
    NCT01602380
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Fulvestrant 500 mg
    regimen
    Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
    analyzed count
    230
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01602380-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-soltamox-0c061d28
    nct id
    NCT01602380
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Anastrozole 1 mg
    regimen
    Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).
    analyzed count
    232
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01602380-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-soltamox-0c061d28
    nct id
    NCT01602380
    harm key
    EG000
    source section id
    NCT01602380-ae
    event group key
    EG000
    event group label
    Fulvestrant 500 mg
    serious affected
    39
    serious at risk
    228
    other affected
    125
    other at risk
    228
    frequency threshold
    5
    collection period
    116 months (duration from first patient enrolled to data cut-off for the final analysis)
    event definition
    All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-soltamox-0c061d28
    nct id
    NCT01602380
    harm key
    EG001
    source section id
    NCT01602380-ae
    event group key
    EG001
    event group label
    Anastrozole 1 mg
    serious affected
    36
    serious at risk
    232
    other affected
    127
    other at risk
    232
    frequency threshold
    5
    collection period
    116 months (duration from first patient enrolled to data cut-off for the final analysis)
    event definition
    All-Cause Mortality: The ITT analysis set included all randomised patients. For serious adverse events and other (non-serious) adverse events: Safety population was defined as all patients who received at least 1 dose of randomised study medication. 2 patients in the Fulvestrant 500 mg arm did not receive treatment and were not included in the safety population.
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-soltamox-0c061d28
    nct id
    NCT01602380
    qol key
    qol-0008
    source section id
    NCT01602380-om-0008
    source outcome index
    8
    instrument
    FACT
    instrument basis
    matched 'fact-b' in the study's own wording
    scale title
    Comparison of the Effect of Fulvestrant Treatment Versus Anastrozole Treatment on Time to Deterioration of Health-Related Quality of Life (HRQoL)
    measure definition
    The Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire was the instrument selected to assess HRQoL and comprised of following subscales: physical well-being (PWB), functional well-being (FWB), social well-being, emotional well-being, and breast cancer subscale (BCS). The main outcome measure from the FACT-B questionnaire was the Trial Outcome Index (TOI), which was a summary of the following subscales: PWB, FWB, and BCS. Outcome measure is reported as median time to deterioration, defined as the interval from the date of baseline of final analysis to the first assessment of worsened without an improvement in the next 12 weeks in FACT-B TOI, or the date of death (by any cause in the absence of symptom deterioration). Time to deterioration as measured by FACT-B total score was derived similarly and is also reported.
    time frame
    Quality of life questionnaires administered at 3 months post objective disease progression, then at 6-monthly intervals (approximately 75 months)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
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    population note
    The ITT analysis set included all randomised patients.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
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    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice