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← Breast Cancer

NCT00248170 · STUDY IN CONTEXT

Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. 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

Disease-free survival was defined as the time from the date of randomization to the date of the first documentation of re-occurrence of invasive breast cancer in local, regional or distant sites, new invasive breast cancer in the contra-lateral breast, or death from any cause.

Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.

→

secondary · POSTED

Overall survival was defined as the time from the date of randomization to the date of death from any cause.

Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.

→

secondary · POSTED

Time to development of distant metastases was defined as the time from date of randomization to the date of the first development of any recurrent or metastatic disease in sites other than the local mastectomy scar, the ipsilateral breast in case of breast conservation or the contra lateral breast.

Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.

→

secondary · POSTED

Time to development of contra lateral breast cancer was defined as the time from the date of randomization to the date of the first development of any disease in the contra lateral breast.

Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.

→

secondary · POSTED

Distant disease-free survival was defined as the time from date of randomization to the date of the first development of any relapse at a distant site or death from any cause.

Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.

→

secondary · POSTED

Total cholesterol was analyzed to assess the impact on serum lipids profiles. The adjusted means was calculated.

Safety Set: The safety set included randomized participants who received at least one of study medication and had at least one post baseline assessment.

→

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

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer
nct id
NCT00248170
trial label
Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
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
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00248170
    outcome key
    om-0000
    source section id
    NCT00248170-om-0000
    source outcome index
    0
    endpoint
    Disease Free Survival
    endpoint definition
    Disease-free survival was defined as the time from the date of randomization to the date of the first documentation of re-occurrence of invasive breast cancer in local, regional or distant sites, new invasive breast cancer in the contra-lateral breast, or death from any cause.
    time origin
    84 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.
    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
    nct id
    NCT00248170
    outcome key
    om-0001
    source section id
    NCT00248170-om-0001
    source outcome index
    1
    endpoint
    Overall Survival
    endpoint definition
    Overall survival was defined as the time from the date of randomization to the date of death from any cause.
    time origin
    84 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.
    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
    nct id
    NCT00248170
    outcome key
    om-0002
    source section id
    NCT00248170-om-0002
    source outcome index
    2
    endpoint
    Time to Development of Distant Metastases
    endpoint definition
    Time to development of distant metastases was defined as the time from date of randomization to the date of the first development of any recurrent or metastatic disease in sites other than the local mastectomy scar, the ipsilateral breast in case of breast conservation or the contra lateral breast.
    time origin
    84 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.
    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
    nct id
    NCT00248170
    outcome key
    om-0003
    source section id
    NCT00248170-om-0003
    source outcome index
    3
    endpoint
    Time to Development of Contra Lateral Breast Cancer
    endpoint definition
    Time to development of contra lateral breast cancer was defined as the time from the date of randomization to the date of the first development of any disease in the contra lateral breast.
    time origin
    84 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.
    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
    nct id
    NCT00248170
    outcome key
    om-0004
    source section id
    NCT00248170-om-0004
    source outcome index
    4
    endpoint
    Distant Disease-free Survival
    endpoint definition
    Distant disease-free survival was defined as the time from date of randomization to the date of the first development of any relapse at a distant site or death from any cause.
    time origin
    84 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat (ITT) - the ITT contained randomized participants who had no protocol deviations.
    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
    nct id
    NCT00248170
    outcome key
    om-0005
    source section id
    NCT00248170-om-0005
    source outcome index
    5
    endpoint
    Change From Baseline in Serum Lipid Profiles
    endpoint definition
    Total cholesterol was analyzed to assess the impact on serum lipids profiles. The adjusted means was calculated.
    time origin
    baseline, 6, 12, 24, 36, 48 and 60 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Safety Set: The safety set included randomized participants who received at least one of study medication and had at least one post baseline assessment.
    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
    nct id
    NCT00248170
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Letrozole
    regimen
    2.5 mg by mouth (p.o.) once daily
    analyzed count
    2061
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00248170-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00248170
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Anastrozole
    regimen
    1 mg p.o. once daily
    analyzed count
    2075
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00248170-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00248170
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Letrozole
    regimen
    2.5 mg by mouth (p.o.) once daily
    analyzed count
    2061
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00248170-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00248170
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Anastrozole
    regimen
    1 mg p.o. once daily
    analyzed count
    2075
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00248170-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00248170
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Letrozole
    regimen
    2.5 mg by mouth (p.o.) once daily
    analyzed count
    2061
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00248170-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00248170
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Anastrozole
    regimen
    1 mg p.o. once daily
    analyzed count
    2075
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00248170-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00248170
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Letrozole
    regimen
    2.5 mg by mouth (p.o.) once daily
    analyzed count
    2061
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00248170-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00248170
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Anastrozole
    regimen
    1 mg p.o. once daily
    analyzed count
    2075
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00248170-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00248170
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Letrozole
    regimen
    2.5 mg by mouth (p.o.) once daily
    analyzed count
    2061
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00248170-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00248170
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Anastrozole
    regimen
    1 mg p.o. once daily
    analyzed count
    2075
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00248170-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00248170
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Letrozole
    regimen
    2.5 mg by mouth (p.o.) once daily
    analyzed count
    2049
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00248170-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00248170
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Anastrozole
    regimen
    1 mg p.o. once daily
    analyzed count
    2062
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00248170-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00248170
    harm key
    EG000
    source section id
    NCT00248170-ae
    event group key
    EG000
    event group label
    Letrozole
    serious affected
    486
    serious at risk
    2049
    other affected
    1747
    other at risk
    2049
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00248170
    harm key
    EG001
    source section id
    NCT00248170-ae
    event group key
    EG001
    event group label
    Anastrozole
    serious affected
    520
    serious at risk
    2062
    other affected
    1762
    other at risk
    2062
    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
    setting source links

      Preserved source evidence · Not medical advice