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NCT00382070 · STUDY IN CONTEXT

Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-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

Percentage of patients free from DFS events. DFS events include local, regional, or distant recurrence, second primary cancer or death from any cause prior to recurrence or second primary cancer.

Source null

→

secondary · POSTED

Percentage of patients alive

Patients with any type of follow up.

→

secondary · POSTED

Cumulative incidence of breast-cancer-free interval events. BCFI events include local-regional recurrence, distant recurrence or contralateral breast cancer as a first event.

Source null

→

secondary · POSTED

Cumulative incidence of distant recurrences.

Source null

→

secondary · POSTED

Cumulative incidence of osteoporotic-related fractures defined as Colles', hip or spinal fractures

Source null

→

secondary · POSTED

Cumulative incidence of arterial thrombotic events, as defined by CTCAE version 4.0 (grade ≥1 stroke or transient ischaemic attack; grade ≥2 acute coronary syndrome or cerebrovascular ischaemia; grade ≥3 myocardial infarction, peripheral ischaemia, or visceral arterial ischaemia; and grade ≥4 selected thromboembolic events \[cerebrovascular event, arterial insufficiency\]).

Source null

→

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
NCT00382070
trial label
Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-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
    NCT00382070
    outcome key
    om-0000
    source section id
    NCT00382070-om-0000
    source outcome index
    0
    endpoint
    Disease-free Survival
    endpoint definition
    Percentage of patients free from DFS events. DFS events include local, regional, or distant recurrence, second primary cancer or death from any cause prior to recurrence or second primary cancer.
    time origin
    7 years.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population 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
    NCT00382070
    outcome key
    om-0001
    source section id
    NCT00382070-om-0001
    source outcome index
    1
    endpoint
    Overall Survival
    endpoint definition
    Percentage of patients alive
    time origin
    7 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients with any type of follow up.
    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
    NCT00382070
    outcome key
    om-0002
    source section id
    NCT00382070-om-0002
    source outcome index
    2
    endpoint
    Breast Cancer-free Interval
    endpoint definition
    Cumulative incidence of breast-cancer-free interval events. BCFI events include local-regional recurrence, distant recurrence or contralateral breast cancer as a first event.
    time origin
    7 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    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
    NCT00382070
    outcome key
    om-0003
    source section id
    NCT00382070-om-0003
    source outcome index
    3
    endpoint
    Distant Recurrence
    endpoint definition
    Cumulative incidence of distant recurrences.
    time origin
    7 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    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
    NCT00382070
    outcome key
    om-0004
    source section id
    NCT00382070-om-0004
    source outcome index
    4
    endpoint
    Osteoporotic-related Fractures
    endpoint definition
    Cumulative incidence of osteoporotic-related fractures defined as Colles', hip or spinal fractures
    time origin
    7 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    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
    NCT00382070
    outcome key
    om-0005
    source section id
    NCT00382070-om-0005
    source outcome index
    5
    endpoint
    Arterial Thrombotic Events
    endpoint definition
    Cumulative incidence of arterial thrombotic events, as defined by CTCAE version 4.0 (grade ≥1 stroke or transient ischaemic attack; grade ≥2 acute coronary syndrome or cerebrovascular ischaemia; grade ≥3 myocardial infarction, peripheral ischaemia, or visceral arterial ischaemia; and grade ≥4 selected thromboembolic events \[cerebrovascular event, arterial insufficiency\]).
    time origin
    7 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    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
    NCT00382070
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Group 2 Letrozole
    regimen
    Patients receive oral letrozole once daily for up to 5 years. Letrozole: Letrozole 2.5 mg taken orally once daily for 5 years
    analyzed count
    1950
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00382070-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00382070
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Group 1 Placebo
    regimen
    Patients receive oral placebo once daily for up to 5 years. Placebo: Placebo tablet taken orally once daily for 5 years
    analyzed count
    1953
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00382070-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00382070
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Group 2 Letrozole
    regimen
    Patients receive oral letrozole once daily for up to 5 years. Letrozole: Letrozole 2.5 mg taken orally once daily for 5 years
    analyzed count
    1959
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00382070-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00382070
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Group 1 Placebo
    regimen
    Patients receive oral placebo once daily for up to 5 years. Placebo: Placebo tablet taken orally once daily for 5 years
    analyzed count
    1964
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00382070-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00382070
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Group 2 Letrozole
    regimen
    Patients receive oral letrozole once daily for up to 5 years. Letrozole: Letrozole 2.5 mg taken orally once daily for 5 years
    analyzed count
    1950
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00382070-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00382070
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Group 1 Placebo
    regimen
    Patients receive oral placebo once daily for up to 5 years. Placebo: Placebo tablet taken orally once daily for 5 years
    analyzed count
    1953
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00382070-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00382070
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Group 2 Letrozole
    regimen
    Patients receive oral letrozole once daily for up to 5 years. Letrozole: Letrozole 2.5 mg taken orally once daily for 5 years
    analyzed count
    1950
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00382070-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00382070
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Group 1 Placebo
    regimen
    Patients receive oral placebo once daily for up to 5 years. Placebo: Placebo tablet taken orally once daily for 5 years
    analyzed count
    1953
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00382070-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00382070
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Group 2 Letrozole
    regimen
    Patients receive oral letrozole once daily for up to 5 years. Letrozole: Letrozole 2.5 mg taken orally once daily for 5 years
    analyzed count
    1950
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00382070-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00382070
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Group 1 Placebo
    regimen
    Patients receive oral placebo once daily for up to 5 years. Placebo: Placebo tablet taken orally once daily for 5 years
    analyzed count
    1953
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00382070-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00382070
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Group 2 Letrozole
    regimen
    Patients receive oral letrozole once daily for up to 5 years. Letrozole: Letrozole 2.5 mg taken orally once daily for 5 years
    analyzed count
    1950
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00382070-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00382070
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Group 1 Placebo
    regimen
    Patients receive oral placebo once daily for up to 5 years. Placebo: Placebo tablet taken orally once daily for 5 years
    analyzed count
    1953
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00382070-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00382070
    harm key
    EG000
    source section id
    NCT00382070-ae
    event group key
    EG000
    event group label
    Placebo
    serious affected
    87
    serious at risk
    1938
    other affected
    336
    other at risk
    1938
    frequency threshold
    5
    collection period
    Source null
    event definition
    Participants at Risk includes any patient who submitted an AE form.
    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
    NCT00382070
    harm key
    EG001
    source section id
    NCT00382070-ae
    event group key
    EG001
    event group label
    Letrozole
    serious affected
    80
    serious at risk
    1951
    other affected
    400
    other at risk
    1951
    frequency threshold
    5
    collection period
    Source null
    event definition
    Participants at Risk includes any patient who submitted an AE form.
    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