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NCT00066690 · BASELINE

Baseline characteristics

Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer · Source last updated 2026-08-26

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
      1018
    2. group Id
      BG001
      value
      1015
    3. group Id
      BG002
      value
      1014
    4. group Id
      BG003
      value
      3047
    units
    Participants
groups
  1. description
    Tamoxifen 20mg orally daily for 5 years
    id
    BG000
    title
    Tamoxifen
  2. description
    Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
    id
    BG001
    title
    T+OFS
  3. description
    Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
    id
    BG002
    title
    E+OFS
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          38
          upper Limit
          46
          value
          43
        2. group Id
          BG001
          lower Limit
          38
          upper Limit
          47
          value
          43
        3. group Id
          BG002
          lower Limit
          38
          upper Limit
          47
          value
          43
        4. group Id
          BG003
          lower Limit
          38
          upper Limit
          47
          value
          43
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          100
        2. group Id
          BG001
          value
          100
        3. group Id
          BG002
          value
          100
        4. group Id
          BG003
          value
          300
      title
      Female
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
      title
      Male
    description
    Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
    param Type
    NUMBER
    title
    Sex/Gender, Customized
    unit Of Measure
    percent of participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          9
      title
      American Indian/Alaskan native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          33
        4. group Id
          BG003
          value
          103
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          34
        4. group Id
          BG003
          value
          93
      title
      Black/African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          12
      title
      Hawaiian/Pacific Islander
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          877
        2. group Id
          BG001
          value
          873
        3. group Id
          BG002
          value
          866
        4. group Id
          BG003
          value
          2616
      title
      White/Caucasian
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          9
      title
      Other
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          63
      title
      Unknown
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          50
        4. group Id
          BG003
          value
          142
      title
      Hispanic/Latino/South American native
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          65.03
        2. group Id
          BG001
          value
          65.22
        3. group Id
          BG002
          value
          66.17
        4. group Id
          BG003
          value
          196.42
      title
      Negative
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          34.97
        2. group Id
          BG001
          value
          34.78
        3. group Id
          BG002
          value
          33.83
        4. group Id
          BG003
          value
          103.58
      title
      Positive
    description
    Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
    param Type
    NUMBER
    title
    Lymph-node status
    unit Of Measure
    percent of participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2.65
        2. group Id
          BG001
          value
          2.46
        3. group Id
          BG002
          value
          2.07
        4. group Id
          BG003
          value
          7.18
      title
      Unknown
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          66.40
        2. group Id
          BG001
          value
          64.63
        3. group Id
          BG002
          value
          66.86
        4. group Id
          BG003
          value
          197.89
      title
      <=2 cm
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          30.94
        2. group Id
          BG001
          value
          32.91
        3. group Id
          BG002
          value
          31.07
        4. group Id
          BG003
          value
          94.92
      title
      >2cm
    description
    Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
    param Type
    NUMBER
    title
    Tumor size
    unit Of Measure
    percent of participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2.36
        2. group Id
          BG001
          value
          2.36
        3. group Id
          BG002
          value
          2.17
        4. group Id
          BG003
          value
          6.89
      title
      Unknown
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          27.01
        2. group Id
          BG001
          value
          26.11
        3. group Id
          BG002
          value
          24.36
        4. group Id
          BG003
          value
          77.48
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          48.33
        2. group Id
          BG001
          value
          50.64
        3. group Id
          BG002
          value
          53.65
        4. group Id
          BG003
          value
          152.62
      title
      2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          22.30
        2. group Id
          BG001
          value
          20.89
        3. group Id
          BG002
          value
          19.82
        4. group Id
          BG003
          value
          63.01
      title
      3
    description
    Tumor grade is the histologic grade according to the BRE method. The method involves assessment of tumor morphology, including tubule formation, nuclear pleomorphism and frequency of mitoses. Grades are recorded according to criteria as 1,2 or 3. Grade 3 is associated with poor prognosis. Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
    param Type
    NUMBER
    title
    Tumor grade
    unit Of Measure
    percent of participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4.32
        2. group Id
          BG001
          value
          2.86
        3. group Id
          BG002
          value
          2.66
        4. group Id
          BG003
          value
          9.84
      title
      Unknown
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          84.18
        2. group Id
          BG001
          value
          85.42
        3. group Id
          BG002
          value
          84.52
        4. group Id
          BG003
          value
          254.12
      title
      Negative
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          11.49
        2. group Id
          BG001
          value
          11.72
        3. group Id
          BG002
          value
          12.82
        4. group Id
          BG003
          value
          36.03
      title
      Positive
    description
    Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
    param Type
    NUMBER
    title
    HER2-status
    unit Of Measure
    percent of participants
population Description
Intention-to-treat population, excludes 19 patients who immediately withdrew consent.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      1018
    2. group Id
      BG001
      value
      1015
    3. group Id
      BG002
      value
      1014
    4. group Id
      BG003
      value
      3047
    units
    Participants
groups
  1. description
    Tamoxifen 20mg orally daily for 5 years
    id
    BG000
    title
    Tamoxifen
  2. description
    Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
    id
    BG001
    title
    T+OFS
  3. description
    Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
    id
    BG002
    title
    E+OFS
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          38
          upper Limit
          46
          value
          43
        2. group Id
          BG001
          lower Limit
          38
          upper Limit
          47
          value
          43
        3. group Id
          BG002
          lower Limit
          38
          upper Limit
          47
          value
          43
        4. group Id
          BG003
          lower Limit
          38
          upper Limit
          47
          value
          43
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          100
        2. group Id
          BG001
          value
          100
        3. group Id
          BG002
          value
          100
        4. group Id
          BG003
          value
          300
      title
      Female
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
      title
      Male
    description
    Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
    param Type
    NUMBER
    title
    Sex/Gender, Customized
    unit Of Measure
    percent of participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          9
      title
      American Indian/Alaskan native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          33
        4. group Id
          BG003
          value
          103
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          34
        4. group Id
          BG003
          value
          93
      title
      Black/African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          12
      title
      Hawaiian/Pacific Islander
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          877
        2. group Id
          BG001
          value
          873
        3. group Id
          BG002
          value
          866
        4. group Id
          BG003
          value
          2616
      title
      White/Caucasian
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          9
      title
      Other
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          63
      title
      Unknown
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          50
        4. group Id
          BG003
          value
          142
      title
      Hispanic/Latino/South American native
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          65.03
        2. group Id
          BG001
          value
          65.22
        3. group Id
          BG002
          value
          66.17
        4. group Id
          BG003
          value
          196.42
      title
      Negative
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          34.97
        2. group Id
          BG001
          value
          34.78
        3. group Id
          BG002
          value
          33.83
        4. group Id
          BG003
          value
          103.58
      title
      Positive
    description
    Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
    param Type
    NUMBER
    title
    Lymph-node status
    unit Of Measure
    percent of participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2.65
        2. group Id
          BG001
          value
          2.46
        3. group Id
          BG002
          value
          2.07
        4. group Id
          BG003
          value
          7.18
      title
      Unknown
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          66.40
        2. group Id
          BG001
          value
          64.63
        3. group Id
          BG002
          value
          66.86
        4. group Id
          BG003
          value
          197.89
      title
      <=2 cm
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          30.94
        2. group Id
          BG001
          value
          32.91
        3. group Id
          BG002
          value
          31.07
        4. group Id
          BG003
          value
          94.92
      title
      >2cm
    description
    Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
    param Type
    NUMBER
    title
    Tumor size
    unit Of Measure
    percent of participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2.36
        2. group Id
          BG001
          value
          2.36
        3. group Id
          BG002
          value
          2.17
        4. group Id
          BG003
          value
          6.89
      title
      Unknown
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          27.01
        2. group Id
          BG001
          value
          26.11
        3. group Id
          BG002
          value
          24.36
        4. group Id
          BG003
          value
          77.48
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          48.33
        2. group Id
          BG001
          value
          50.64
        3. group Id
          BG002
          value
          53.65
        4. group Id
          BG003
          value
          152.62
      title
      2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          22.30
        2. group Id
          BG001
          value
          20.89
        3. group Id
          BG002
          value
          19.82
        4. group Id
          BG003
          value
          63.01
      title
      3
    description
    Tumor grade is the histologic grade according to the BRE method. The method involves assessment of tumor morphology, including tubule formation, nuclear pleomorphism and frequency of mitoses. Grades are recorded according to criteria as 1,2 or 3. Grade 3 is associated with poor prognosis. Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
    param Type
    NUMBER
    title
    Tumor grade
    unit Of Measure
    percent of participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4.32
        2. group Id
          BG001
          value
          2.86
        3. group Id
          BG002
          value
          2.66
        4. group Id
          BG003
          value
          9.84
      title
      Unknown
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          84.18
        2. group Id
          BG001
          value
          85.42
        3. group Id
          BG002
          value
          84.52
        4. group Id
          BG003
          value
          254.12
      title
      Negative
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          11.49
        2. group Id
          BG001
          value
          11.72
        3. group Id
          BG002
          value
          12.82
        4. group Id
          BG003
          value
          36.03
      title
      Positive
    description
    Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
    param Type
    NUMBER
    title
    HER2-status
    unit Of Measure
    percent of participants
population Description
Intention-to-treat population, excludes 19 patients who immediately withdrew consent.

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Preserved source evidence · Not medical advice