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NCT01242800 · BASELINE

Baseline characteristics

Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer · Source last updated 2023-06-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      131
    2. group Id
      BG001
      value
      125
    3. group Id
      BG002
      value
      256
    units
    Participants
groups
  1. description
    Patients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both. palliative surgery: Undergo standard palliative surgery palliative radiation therapy: Undergo standard palliative radiotherapy
    id
    BG000
    title
    Arm I (Continued Systemic Therapy)
  2. description
    Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Surgery is to occur no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician. therapeutic conventional surgery: Undergo early surgery radiation therapy: Undergo radiotherapy
    id
    BG001
    title
    Arm II (Early Local Therapy)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          25
          upper Limit
          86
          value
          56
        2. group Id
          BG001
          lower Limit
          30
          upper Limit
          81
          value
          55
        3. group Id
          BG002
          lower Limit
          25
          upper Limit
          86
          value
          56
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          131
        2. group Id
          BG001
          value
          125
        3. group Id
          BG002
          value
          256
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          38
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          102
        2. group Id
          BG001
          value
          98
        3. group Id
          BG002
          value
          200
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          13
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
All randomized patients at step 2
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      131
    2. group Id
      BG001
      value
      125
    3. group Id
      BG002
      value
      256
    units
    Participants
groups
  1. description
    Patients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both. palliative surgery: Undergo standard palliative surgery palliative radiation therapy: Undergo standard palliative radiotherapy
    id
    BG000
    title
    Arm I (Continued Systemic Therapy)
  2. description
    Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Surgery is to occur no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician. therapeutic conventional surgery: Undergo early surgery radiation therapy: Undergo radiotherapy
    id
    BG001
    title
    Arm II (Early Local Therapy)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          25
          upper Limit
          86
          value
          56
        2. group Id
          BG001
          lower Limit
          30
          upper Limit
          81
          value
          55
        3. group Id
          BG002
          lower Limit
          25
          upper Limit
          86
          value
          56
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          131
        2. group Id
          BG001
          value
          125
        3. group Id
          BG002
          value
          256
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          38
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          102
        2. group Id
          BG001
          value
          98
        3. group Id
          BG002
          value
          200
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          13
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
All randomized patients at step 2

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Preserved source evidence · Not medical advice