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NCT00066573 · STUDY IN CONTEXT

Exemestane or Anastrozole in Treating Postmenopausal Women Who Have Undergone Surgery for Primary 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

Event free survival, the primary endpoint of this study, is defined as the time from randomization to the time of documented locoregional or distant recurrence, new primary breast cancer, or death from any cause.

Source null

→

secondary · POSTED

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

Intend to treat

→

secondary · POSTED

Time to distant disease-free survival (DDFS) is defined as the time from randomization to the time of documented distant recurrence. Distant recurrence is the cancer coming back in a part of the body away from the breast, such as the bones or liver.

Intent to treat

→

secondary · POSTED

Clinical fracture at any time, including hip, spine, wrist fractures and other bone fractures.

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
NCT00066573
trial label
Exemestane or Anastrozole in Treating Postmenopausal Women Who Have Undergone Surgery for Primary 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
4
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00066573
    outcome key
    om-0000
    source section id
    NCT00066573-om-0000
    source outcome index
    0
    endpoint
    Event-free Survival
    endpoint definition
    Event free survival, the primary endpoint of this study, is defined as the time from randomization to the time of documented locoregional or distant recurrence, new primary breast cancer, or death from any cause.
    time origin
    5 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
    NCT00066573
    outcome key
    om-0001
    source section id
    NCT00066573-om-0001
    source outcome index
    1
    endpoint
    Overall Survival: Percentage of Participants Alive at 5 Years
    endpoint definition
    Overall survival is defined as the time from randomization to the time of death from any cause.
    time origin
    5 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intend to treat
    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
    NCT00066573
    outcome key
    om-0002
    source section id
    NCT00066573-om-0002
    source outcome index
    2
    endpoint
    Distant Disease-free Survival: Number of Participants Without Documented Distant Recurrence
    endpoint definition
    Time to distant disease-free survival (DDFS) is defined as the time from randomization to the time of documented distant recurrence. Distant recurrence is the cancer coming back in a part of the body away from the breast, such as the bones or liver.
    time origin
    5 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent to treat
    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
    NCT00066573
    outcome key
    om-0003
    source section id
    NCT00066573-om-0003
    source outcome index
    3
    endpoint
    Clinical Fracture Rate: Number of Participants With Bone Fractures.
    endpoint definition
    Clinical fracture at any time, including hip, spine, wrist fractures and other bone fractures.
    time origin
    8 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
    NCT00066573
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Exemestane
    regimen
    Patients receive oral exemestane (25 mg) once daily for 5 years. exemestane: Given orally
    analyzed count
    3789
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00066573-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00066573
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Anastrozole
    regimen
    Patients receive oral anastrozole (1 mg) once daily for 5 years. anastrozole: Given orally
    analyzed count
    3787
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00066573-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00066573
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Exemestane
    regimen
    Patients receive oral exemestane (25 mg) once daily for 5 years. exemestane: Given orally
    analyzed count
    3789
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00066573-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00066573
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Anastrozole
    regimen
    Patients receive oral anastrozole (1 mg) once daily for 5 years. anastrozole: Given orally
    analyzed count
    3787
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00066573-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00066573
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Exemestane
    regimen
    Patients receive oral exemestane (25 mg) once daily for 5 years. exemestane: Given orally
    analyzed count
    3789
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00066573-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00066573
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Anastrozole
    regimen
    Patients receive oral anastrozole (1 mg) once daily for 5 years. anastrozole: Given orally
    analyzed count
    3787
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00066573-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00066573
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Exemestane
    regimen
    Patients receive oral exemestane (25 mg) once daily for 5 years. exemestane: Given orally
    analyzed count
    3789
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00066573-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00066573
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Anastrozole
    regimen
    Patients receive oral anastrozole (1 mg) once daily for 5 years. anastrozole: Given orally
    analyzed count
    3787
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00066573-om-0003#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00066573
    harm key
    EG000
    source section id
    NCT00066573-ae
    event group key
    EG000
    event group label
    Exemestane
    serious affected
    19
    serious at risk
    3761
    other affected
    3556
    other at risk
    3761
    frequency threshold
    5
    collection period
    8 years
    event definition
    Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
    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
    NCT00066573
    harm key
    EG001
    source section id
    NCT00066573-ae
    event group key
    EG001
    event group label
    Anastrozole
    serious affected
    7
    serious at risk
    3759
    other affected
    3543
    other at risk
    3759
    frequency threshold
    5
    collection period
    8 years
    event definition
    Participants at Risk of Adverse Event or SAE were those who received at least one dose of protocol therapy.
    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