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← Breast Cancer

NCT00003830 · STUDY IN CONTEXT

Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With 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

Morbidity as measured by residual shoulder abduction deficit. Shoulder Abduction Deficit definition: Shoulder range of motion decreased by greater than or equal to 10% as compared with that measured prior to surgery.

Data missing or unknown for some patients

→

primary · POSTED

Morbidity as measured by residual arm volume difference. Residual Arm Volume Difference definition: Arm volume differences greater than or equal to 10% as compared with that measured prior to surgery

Data missing or unknown for some patients.

→

primary · POSTED

Morbidity as measured by residual arm numbness

Data missing or unknown for some patients

→

primary · POSTED

Morbidity as measured by residual arm tingling

Data missing or unknown for some patients

→

primary · POSTED

Measured at the time from randomization to any death to determine the percentage of patients alive at 8 years

Data missing or unknown for some patients

→

primary · POSTED

Measured at time from randomization to recurrence, second primary, or death to determine the percentage of patients disease free at 8 years.

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
NCT00003830
trial label
Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With 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
    NCT00003830
    outcome key
    om-0000
    source section id
    NCT00003830-om-0000
    source outcome index
    0
    endpoint
    Morbidity - Number of Participants With Residual Shoulder Abduction Deficit
    endpoint definition
    Morbidity as measured by residual shoulder abduction deficit. Shoulder Abduction Deficit definition: Shoulder range of motion decreased by greater than or equal to 10% as compared with that measured prior to surgery.
    time origin
    Before and after surgery (within 30 days of randomization)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Data missing or unknown for some 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
    nct id
    NCT00003830
    outcome key
    om-0001
    source section id
    NCT00003830-om-0001
    source outcome index
    1
    endpoint
    Morbidity - Number of Participants With Residual Arm Volume Difference
    endpoint definition
    Morbidity as measured by residual arm volume difference. Residual Arm Volume Difference definition: Arm volume differences greater than or equal to 10% as compared with that measured prior to surgery
    time origin
    before and after surgery (within 30 days of randomization)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Data missing or unknown for some patients.
    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
    NCT00003830
    outcome key
    om-0002
    source section id
    NCT00003830-om-0002
    source outcome index
    2
    endpoint
    Morbidity - Number of Participants With Residual Arm Numbness
    endpoint definition
    Morbidity as measured by residual arm numbness
    time origin
    before and after surgery (within 30 days of randomization)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Data missing or unknown for some patients
    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
    NCT00003830
    outcome key
    om-0003
    source section id
    NCT00003830-om-0003
    source outcome index
    3
    endpoint
    Morbidity - Number of Participants With Residual Arm Tingling
    endpoint definition
    Morbidity as measured by residual arm tingling
    time origin
    before and after surgery (within 30 days of randomization)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Data missing or unknown for some patients
    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
    NCT00003830
    outcome key
    om-0004
    source section id
    NCT00003830-om-0004
    source outcome index
    4
    endpoint
    Overall Survival
    endpoint definition
    Measured at the time from randomization to any death to determine the percentage of patients alive at 8 years
    time origin
    8 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Data missing or unknown for some patients
    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
    NCT00003830
    outcome key
    om-0005
    source section id
    NCT00003830-om-0005
    source outcome index
    5
    endpoint
    Disease-free Survival as Measured by Breast Cancer Recurrence, Any Second Primary Cancer, and Death From Any Cause in Patients Without a Prior Event.
    endpoint definition
    Measured at time from randomization to recurrence, second primary, or death to determine the percentage of patients disease free at 8 years.
    time origin
    8 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
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00003830
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm I:Sentinel Node Resection+Conventional Axillary Dissection
    regimen
    Sentinel node resection immediately followed by axillary dissection conventional surgery: Sentinel node resection immediately followed by axillary dissection.
    analyzed count
    1449
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00003830-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00003830
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm II: Sentinel Node Resection Followed by Node Examination
    regimen
    Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. Sentinel node resection followed by node examination: Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node.
    analyzed count
    1519
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00003830-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00003830
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm I:Sentinel Node Resection+Conventional Axillary Dissection
    regimen
    Sentinel node resection immediately followed by axillary dissection conventional surgery: Sentinel node resection immediately followed by axillary dissection.
    analyzed count
    1136
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00003830-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00003830
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Arm II: Sentinel Node Resection Followed by Node Examination
    regimen
    Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. Sentinel node resection followed by node examination: Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node.
    analyzed count
    1151
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00003830-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00003830
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm I:Sentinel Node Resection+Conventional Axillary Dissection
    regimen
    Sentinel node resection immediately followed by axillary dissection conventional surgery: Sentinel node resection immediately followed by axillary dissection.
    analyzed count
    1336
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00003830-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00003830
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Arm II: Sentinel Node Resection Followed by Node Examination
    regimen
    Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. Sentinel node resection followed by node examination: Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node.
    analyzed count
    1371
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00003830-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00003830
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Arm I:Sentinel Node Resection+Conventional Axillary Dissection
    regimen
    Sentinel node resection immediately followed by axillary dissection conventional surgery: Sentinel node resection immediately followed by axillary dissection.
    analyzed count
    1329
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00003830-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00003830
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Arm II: Sentinel Node Resection Followed by Node Examination
    regimen
    Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. Sentinel node resection followed by node examination: Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node.
    analyzed count
    1343
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00003830-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00003830
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Arm I:Sentinel Node Resection+Conventional Axillary Dissection
    regimen
    Sentinel node resection immediately followed by axillary dissection conventional surgery: Sentinel node resection immediately followed by axillary dissection.
    analyzed count
    1975
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00003830-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00003830
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Arm II: Sentinel Node Resection Followed by Node Examination
    regimen
    Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. Sentinel node resection followed by node examination: Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node.
    analyzed count
    2011
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00003830-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00003830
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Arm I:Sentinel Node Resection+Conventional Axillary Dissection
    regimen
    Sentinel node resection immediately followed by axillary dissection conventional surgery: Sentinel node resection immediately followed by axillary dissection.
    analyzed count
    1975
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00003830-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00003830
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Arm II: Sentinel Node Resection Followed by Node Examination
    regimen
    Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. Sentinel node resection followed by node examination: Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node.
    analyzed count
    2011
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00003830-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer
    nct id
    NCT00003830
    harm key
    EG000
    source section id
    NCT00003830-ae
    event group key
    EG000
    event group label
    Conventional Axillary Dissection
    serious affected
    9
    serious at risk
    2788
    other affected
    0
    other at risk
    2788
    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
    NCT00003830
    harm key
    EG001
    source section id
    NCT00003830-ae
    event group key
    EG001
    event group label
    Sentinel Node Resection Followed by Node Examination
    serious affected
    8
    serious at risk
    2800
    other affected
    0
    other at risk
    2800
    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