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NCT00553410 · BASELINE

Baseline characteristics

Letrozole in Preventing Cancer in Postmenopausal Women Who Have Received 4-6 Years of Hormone Therapy for Hormone Receptor-Positive, Lymph Node-Positive, Early-Stage Breast Cancer · Source last updated 2026-09-01

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
      2426
    2. group Id
      BG001
      value
      2425
    3. group Id
      BG002
      value
      4851
    units
    Participants
groups
  1. description
    Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily) Letrozole: Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously
    id
    BG000
    title
    Arm A: Continuous Letrozole
  2. description
    Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months Letrozole: Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months
    id
    BG001
    title
    Arm B: Intermittent Letrozole
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          668
        2. group Id
          BG001
          value
          671
        3. group Id
          BG002
          value
          1339
      title
      <55
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          504
        2. group Id
          BG001
          value
          496
        3. group Id
          BG002
          value
          1000
      title
      55-59
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          451
        2. group Id
          BG001
          value
          471
        3. group Id
          BG002
          value
          922
      title
      60-64
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          400
        2. group Id
          BG001
          value
          375
        3. group Id
          BG002
          value
          775
      title
      65-69
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          383
        2. group Id
          BG001
          value
          412
        3. group Id
          BG002
          value
          795
      title
      70+
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2426
        2. group Id
          BG001
          value
          2425
        3. group Id
          BG002
          value
          4851
        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
          2199
        2. group Id
          BG001
          value
          2211
        3. group Id
          BG002
          value
          4410
      title
      White/Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          19
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          119
        2. group Id
          BG001
          value
          121
        3. group Id
          BG002
          value
          240
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          97
        2. group Id
          BG001
          value
          83
        3. group Id
          BG002
          value
          180
      title
      Other
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          78
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          155
      title
      Hungary
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          40
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          93
        2. group Id
          BG001
          value
          99
        3. group Id
          BG002
          value
          192
      title
      Japan
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          217
        2. group Id
          BG001
          value
          216
        3. group Id
          BG002
          value
          433
      title
      United Kingdom
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          159
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          318
      title
      Switzerland
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          16
      title
      India
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          43
      title
      Russia
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          137
        2. group Id
          BG001
          value
          134
        3. group Id
          BG002
          value
          271
      title
      Spain
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          19
      title
      New Zealand
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          88
        2. group Id
          BG001
          value
          92
        3. group Id
          BG002
          value
          180
      title
      Austria
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          105
        3. group Id
          BG002
          value
          209
      title
      Sweden
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          509
        2. group Id
          BG001
          value
          520
        3. group Id
          BG002
          value
          1029
      title
      Belgium
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Randomized patients, regardless of eligibility status; exceptions were patients who immediately withdrew consent prior to treatment initiation and declined all participation, patients determined to be without adequate documentation of informed consent, and/or patients at a participating center determined not to be compliant with protocol procedures
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      2426
    2. group Id
      BG001
      value
      2425
    3. group Id
      BG002
      value
      4851
    units
    Participants
groups
  1. description
    Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily) Letrozole: Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously
    id
    BG000
    title
    Arm A: Continuous Letrozole
  2. description
    Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months Letrozole: Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months
    id
    BG001
    title
    Arm B: Intermittent Letrozole
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          668
        2. group Id
          BG001
          value
          671
        3. group Id
          BG002
          value
          1339
      title
      <55
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          504
        2. group Id
          BG001
          value
          496
        3. group Id
          BG002
          value
          1000
      title
      55-59
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          451
        2. group Id
          BG001
          value
          471
        3. group Id
          BG002
          value
          922
      title
      60-64
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          400
        2. group Id
          BG001
          value
          375
        3. group Id
          BG002
          value
          775
      title
      65-69
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          383
        2. group Id
          BG001
          value
          412
        3. group Id
          BG002
          value
          795
      title
      70+
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2426
        2. group Id
          BG001
          value
          2425
        3. group Id
          BG002
          value
          4851
        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
          2199
        2. group Id
          BG001
          value
          2211
        3. group Id
          BG002
          value
          4410
      title
      White/Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          19
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          119
        2. group Id
          BG001
          value
          121
        3. group Id
          BG002
          value
          240
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          97
        2. group Id
          BG001
          value
          83
        3. group Id
          BG002
          value
          180
      title
      Other
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          78
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          155
      title
      Hungary
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          40
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          93
        2. group Id
          BG001
          value
          99
        3. group Id
          BG002
          value
          192
      title
      Japan
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          217
        2. group Id
          BG001
          value
          216
        3. group Id
          BG002
          value
          433
      title
      United Kingdom
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          159
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          318
      title
      Switzerland
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          16
      title
      India
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          43
      title
      Russia
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          137
        2. group Id
          BG001
          value
          134
        3. group Id
          BG002
          value
          271
      title
      Spain
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          19
      title
      New Zealand
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          88
        2. group Id
          BG001
          value
          92
        3. group Id
          BG002
          value
          180
      title
      Austria
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          105
        3. group Id
          BG002
          value
          209
      title
      Sweden
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          509
        2. group Id
          BG001
          value
          520
        3. group Id
          BG002
          value
          1029
      title
      Belgium
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Randomized patients, regardless of eligibility status; exceptions were patients who immediately withdrew consent prior to treatment initiation and declined all participation, patients determined to be without adequate documentation of informed consent, and/or patients at a participating center determined not to be compliant with protocol procedures

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Preserved source evidence · Not medical advice