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NCT00074152 · STUDY IN CONTEXT

Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer; Chemotherapy as Adjuvant for LOcally Recurrent Breast Cancer

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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

Source null

→

secondary · POSTED

Overall Survival

Source null

→

secondary · POSTED

Tumor recurrence in the breast, lymph nodes or other areas of the body including bone, lung, liver, central nervous system, bone marrow

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-recurrent-6bbbba73
nct id
NCT00074152
trial label
Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer; Chemotherapy as Adjuvant for LOcally Recurrent Breast Cancer
applicability
unclear
applicability note
Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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
3
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-recurrent-6bbbba73
    nct id
    NCT00074152
    outcome key
    om-0000
    source section id
    NCT00074152-om-0000
    source outcome index
    0
    endpoint
    Disease-free Survival
    endpoint definition
    Disease-free Survival
    time origin
    5 years after randomization
    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-recurrent-6bbbba73
    nct id
    NCT00074152
    outcome key
    om-0001
    source section id
    NCT00074152-om-0001
    source outcome index
    1
    endpoint
    Overall Survival
    endpoint definition
    Overall Survival
    time origin
    5 years after randomization
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-recurrent-6bbbba73
    nct id
    NCT00074152
    outcome key
    om-0002
    source section id
    NCT00074152-om-0002
    source outcome index
    2
    endpoint
    Sites of First Failures
    endpoint definition
    Tumor recurrence in the breast, lymph nodes or other areas of the body including bone, lung, liver, central nervous system, bone marrow
    time origin
    5 years after randomization
    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-recurrent-6bbbba73
    nct id
    NCT00074152
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm I
    regimen
    Observation (+/- Radiation). Patients receive radiotherapy\* within 6 months after surgery. radiation therapy: Given within 6 months after surgery
    analyzed count
    77
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00074152-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-recurrent-6bbbba73
    nct id
    NCT00074152
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm II
    regimen
    Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy. chemotherapy: Given within 10 weeks after surgery.
    analyzed count
    85
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00074152-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-recurrent-6bbbba73
    nct id
    NCT00074152
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm I
    regimen
    Observation (+/- Radiation).Patients receive radiotherapy\* within 6 months after surgery. radiation therapy: Given within 6 months after surgery
    analyzed count
    77
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00074152-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-recurrent-6bbbba73
    nct id
    NCT00074152
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Arm II
    regimen
    Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy. chemotherapy: Given within 10 weeks after surgery.
    analyzed count
    85
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00074152-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-recurrent-6bbbba73
    nct id
    NCT00074152
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm I
    regimen
    Observation (+/- Radiation).Patients receive radiotherapy\* within 6 months after surgery. radiation therapy: Given within 6 months after surgery
    analyzed count
    77
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00074152-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-recurrent-6bbbba73
    nct id
    NCT00074152
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Arm II
    regimen
    Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy. chemotherapy: Given within 10 weeks after surgery.
    analyzed count
    85
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00074152-om-0002#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-recurrent-6bbbba73
    nct id
    NCT00074152
    harm key
    EG000
    source section id
    NCT00074152-ae
    event group key
    EG000
    event group label
    Arm I
    serious affected
    0
    serious at risk
    77
    other affected
    0
    other at risk
    77
    frequency threshold
    0
    collection period
    From date patient provided informed consent until 4 weeks after study treatment completion, beyond 4 weeks after stopping study treatment any death or serious adverse event considered possibly related to previous study treatment (approximately 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-recurrent-6bbbba73
    nct id
    NCT00074152
    harm key
    EG001
    source section id
    NCT00074152-ae
    event group key
    EG001
    event group label
    Arm II
    serious affected
    12
    serious at risk
    85
    other affected
    0
    other at risk
    85
    frequency threshold
    0
    collection period
    From date patient provided informed consent until 4 weeks after study treatment completion, beyond 4 weeks after stopping study treatment any death or serious adverse event considered possibly related to previous study treatment (approximately 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