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NCT00005957 · STUDY IN CONTEXT

Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive 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

Duration of study

Intention-to-treat

→

secondary · POSTED

Disease-free survival (including locoregional and distant disease)

Intention-to-treat

→

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
NCT00005957
trial label
Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive 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
2
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00005957
    outcome key
    om-0000
    source section id
    NCT00005957-om-0000
    source outcome index
    0
    endpoint
    Overall Survival
    endpoint definition
    Duration of study
    time origin
    10 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intention-to-treat
    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
    NCT00005957
    outcome key
    om-0001
    source section id
    NCT00005957-om-0001
    source outcome index
    1
    endpoint
    Disease-free Survival
    endpoint definition
    Disease-free survival (including locoregional and distant disease)
    time origin
    10 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intention-to-treat
    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
    NCT00005957
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Standard Breast Irradiation
    regimen
    radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
    analyzed count
    916
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00005957-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00005957
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Breast Radiation Plus Regional Radiation
    regimen
    regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes) Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.
    analyzed count
    916
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00005957-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00005957
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Standard Breast Irradiation
    regimen
    radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
    analyzed count
    916
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00005957-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00005957
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Breast Radiation Plus Regional Radiation
    regimen
    regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes) Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.
    analyzed count
    916
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00005957-om-0001#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00005957
    harm key
    EG000
    source section id
    NCT00005957-ae
    event group key
    EG000
    event group label
    Standard Breast Irradiation
    serious affected
    1
    serious at risk
    927
    other affected
    745
    other at risk
    927
    frequency threshold
    5
    collection period
    10 years
    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
    NCT00005957
    harm key
    EG001
    source section id
    NCT00005957-ae
    event group key
    EG001
    event group label
    Breast Radiation Plus Regional Radiation
    serious affected
    3
    serious at risk
    893
    other affected
    752
    other at risk
    893
    frequency threshold
    5
    collection period
    10 years
    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