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NCT00310180 · BASELINE

Baseline characteristics

Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial) · Source last updated 2026-09-08

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
      1619
    2. group Id
      BG001
      value
      3399
    3. group Id
      BG002
      value
      3312
    4. group Id
      BG003
      value
      1389
    5. group Id
      BG004
      value
      9719
    units
    Participants
groups
  1. description
    Group 1 (Oncotype DX recurrence score =\< 10): Patients in this group receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane PO for up to 5 years. Some patients then continue to receive hormone therapy for an additional 5 years. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO
    id
    BG000
    title
    Arm A
  2. description
    Group 2 (Oncotype DX recurrence score 11-25): Patients receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane PO for up to 5 years. Some patients then continue to receive hormone therapy for an additional 5 years. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO
    id
    BG001
    title
    Arm B
  3. description
    Group 2 (Oncotype DX recurrence score 11-25): Patients receive standard combination chemotherapy at the discretion of the treating physician. Within 4 weeks after the last dose of chemotherapy, patients receive hormonal therapy as in Group 1 at the discretion of the treating physician. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO Combination chemotherapy: including oral CMF, IV CMF, standard AC, dose dense AC, standard AC-T, dose dense AC-T, FEC, TAC, TC, other protocol-specified regimens if participating in other CTSU trials including chemotherapy, and other regimens not protocol-specified if not participating in CTSU trials
    id
    BG002
    title
    Arm C
  4. description
    Group 3 (Oncotype DX recurrence score \>= 26): Patients in this group receive combination chemotherapy followed by hormone therapy similar to the patients in Group 2 who are assigned to receive both types of treatment. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO Combination chemotherapy: including oral CMF, IV CMF, standard AC, dose dense AC, standard AC-T, dose dense AC-T, FEC, TAC, TC, other protocol-specified regimens if participating in other CTSU trials including chemotherapy, and other regimens not protocol-specified if not participating in CTSU trials
    id
    BG003
    title
    Arm D
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          154
        3. group Id
          BG002
          value
          157
        4. group Id
          BG003
          value
          79
        5. group Id
          BG004
          value
          448
        title
        <=40 years
      2. measurements
        1. group Id
          BG000
          value
          371
        2. group Id
          BG001
          value
          985
        3. group Id
          BG002
          value
          920
        4. group Id
          BG003
          value
          330
        5. group Id
          BG004
          value
          2606
        title
        41-50 years
      3. measurements
        1. group Id
          BG000
          value
          563
        2. group Id
          BG001
          value
          1235
        3. group Id
          BG002
          value
          1206
        4. group Id
          BG003
          value
          512
        5. group Id
          BG004
          value
          3516
        title
        51-60 years
      4. measurements
        1. group Id
          BG000
          value
          518
        2. group Id
          BG001
          value
          868
        3. group Id
          BG002
          value
          895
        4. group Id
          BG003
          value
          395
        5. group Id
          BG004
          value
          2676
        title
        61-70 years
      5. measurements
        1. group Id
          BG000
          value
          109
        2. group Id
          BG001
          value
          157
        3. group Id
          BG002
          value
          134
        4. group Id
          BG003
          value
          73
        5. group Id
          BG004
          value
          473
        title
        71-75 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1619
        2. group Id
          BG001
          value
          3399
        3. group Id
          BG002
          value
          3312
        4. group Id
          BG003
          value
          1389
        5. group Id
          BG004
          value
          9719
        title
        Female
      2. 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
        5. group Id
          BG004
          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
          8
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          39
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          82
        2. group Id
          BG001
          value
          140
        3. group Id
          BG002
          value
          132
        4. group Id
          BG003
          value
          51
        5. group Id
          BG004
          value
          405
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          30
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          107
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          235
        4. group Id
          BG003
          value
          115
        5. group Id
          BG004
          value
          693
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          1361
        2. group Id
          BG001
          value
          2883
        3. group Id
          BG002
          value
          2783
        4. group Id
          BG003
          value
          1162
        5. group Id
          BG004
          value
          8189
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          10
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          117
        3. group Id
          BG002
          value
          130
        4. group Id
          BG003
          value
          55
        5. group Id
          BG004
          value
          353
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          432
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          432
        title
        0-5
      2. measurements
        1. group Id
          BG000
          value
          1187
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1187
        title
        6-10
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1214
        3. group Id
          BG002
          value
          1159
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2373
        title
        11-15
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1368
        3. group Id
          BG002
          value
          1344
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2712
        title
        16-20
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          817
        3. group Id
          BG002
          value
          809
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1626
        title
        21-25
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          598
        5. group Id
          BG004
          value
          598
        title
        26-30
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          315
        5. group Id
          BG004
          value
          315
        title
        31-35
      8. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          158
        5. group Id
          BG004
          value
          158
        title
        36-40
      9. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          202
        5. group Id
          BG004
          value
          202
        title
        41-50
      10. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          116
        5. group Id
          BG004
          value
          116
        title
        >50
    description
    The Oncotype DX assay is a 21-gene assay that predicts the likelihood of chemotherapy benefit and 10-year risk of distant recurrence to inform adjuvant treatment decisions in certain women with early-stage invasive breast cancer. Oncotype DX test results assign a Recurrence Score, and the Oncotype DX Recurrence Score is a continuous score, ranged between 0 and 100, that provides an individual estimate of the 10 year risk of distant recurrence and predicts the likelihood of benefit from chemotherapy. Higher score indicate higher risk of recurrence.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Recurrence score
    unit Of Measure
    Participants
population Description
All eligible patients who had on-study data and follow-up data were included in the analysis
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      1619
    2. group Id
      BG001
      value
      3399
    3. group Id
      BG002
      value
      3312
    4. group Id
      BG003
      value
      1389
    5. group Id
      BG004
      value
      9719
    units
    Participants
groups
  1. description
    Group 1 (Oncotype DX recurrence score =\< 10): Patients in this group receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane PO for up to 5 years. Some patients then continue to receive hormone therapy for an additional 5 years. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO
    id
    BG000
    title
    Arm A
  2. description
    Group 2 (Oncotype DX recurrence score 11-25): Patients receive hormone therapy with tamoxifen, anastrozole, letrozole, or exemestane PO for up to 5 years. Some patients then continue to receive hormone therapy for an additional 5 years. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO
    id
    BG001
    title
    Arm B
  3. description
    Group 2 (Oncotype DX recurrence score 11-25): Patients receive standard combination chemotherapy at the discretion of the treating physician. Within 4 weeks after the last dose of chemotherapy, patients receive hormonal therapy as in Group 1 at the discretion of the treating physician. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO Combination chemotherapy: including oral CMF, IV CMF, standard AC, dose dense AC, standard AC-T, dose dense AC-T, FEC, TAC, TC, other protocol-specified regimens if participating in other CTSU trials including chemotherapy, and other regimens not protocol-specified if not participating in CTSU trials
    id
    BG002
    title
    Arm C
  4. description
    Group 3 (Oncotype DX recurrence score \>= 26): Patients in this group receive combination chemotherapy followed by hormone therapy similar to the patients in Group 2 who are assigned to receive both types of treatment. Anastrozole: Given PO Exemestane: Given PO Letrozole: Given PO Tamoxifen: Given PO Combination chemotherapy: including oral CMF, IV CMF, standard AC, dose dense AC, standard AC-T, dose dense AC-T, FEC, TAC, TC, other protocol-specified regimens if participating in other CTSU trials including chemotherapy, and other regimens not protocol-specified if not participating in CTSU trials
    id
    BG003
    title
    Arm D
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          154
        3. group Id
          BG002
          value
          157
        4. group Id
          BG003
          value
          79
        5. group Id
          BG004
          value
          448
        title
        <=40 years
      2. measurements
        1. group Id
          BG000
          value
          371
        2. group Id
          BG001
          value
          985
        3. group Id
          BG002
          value
          920
        4. group Id
          BG003
          value
          330
        5. group Id
          BG004
          value
          2606
        title
        41-50 years
      3. measurements
        1. group Id
          BG000
          value
          563
        2. group Id
          BG001
          value
          1235
        3. group Id
          BG002
          value
          1206
        4. group Id
          BG003
          value
          512
        5. group Id
          BG004
          value
          3516
        title
        51-60 years
      4. measurements
        1. group Id
          BG000
          value
          518
        2. group Id
          BG001
          value
          868
        3. group Id
          BG002
          value
          895
        4. group Id
          BG003
          value
          395
        5. group Id
          BG004
          value
          2676
        title
        61-70 years
      5. measurements
        1. group Id
          BG000
          value
          109
        2. group Id
          BG001
          value
          157
        3. group Id
          BG002
          value
          134
        4. group Id
          BG003
          value
          73
        5. group Id
          BG004
          value
          473
        title
        71-75 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1619
        2. group Id
          BG001
          value
          3399
        3. group Id
          BG002
          value
          3312
        4. group Id
          BG003
          value
          1389
        5. group Id
          BG004
          value
          9719
        title
        Female
      2. 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
        5. group Id
          BG004
          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
          8
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          39
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          82
        2. group Id
          BG001
          value
          140
        3. group Id
          BG002
          value
          132
        4. group Id
          BG003
          value
          51
        5. group Id
          BG004
          value
          405
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          30
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          107
        2. group Id
          BG001
          value
          236
        3. group Id
          BG002
          value
          235
        4. group Id
          BG003
          value
          115
        5. group Id
          BG004
          value
          693
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          1361
        2. group Id
          BG001
          value
          2883
        3. group Id
          BG002
          value
          2783
        4. group Id
          BG003
          value
          1162
        5. group Id
          BG004
          value
          8189
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          10
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          117
        3. group Id
          BG002
          value
          130
        4. group Id
          BG003
          value
          55
        5. group Id
          BG004
          value
          353
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          432
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          432
        title
        0-5
      2. measurements
        1. group Id
          BG000
          value
          1187
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1187
        title
        6-10
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1214
        3. group Id
          BG002
          value
          1159
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2373
        title
        11-15
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1368
        3. group Id
          BG002
          value
          1344
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2712
        title
        16-20
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          817
        3. group Id
          BG002
          value
          809
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1626
        title
        21-25
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          598
        5. group Id
          BG004
          value
          598
        title
        26-30
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          315
        5. group Id
          BG004
          value
          315
        title
        31-35
      8. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          158
        5. group Id
          BG004
          value
          158
        title
        36-40
      9. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          202
        5. group Id
          BG004
          value
          202
        title
        41-50
      10. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          116
        5. group Id
          BG004
          value
          116
        title
        >50
    description
    The Oncotype DX assay is a 21-gene assay that predicts the likelihood of chemotherapy benefit and 10-year risk of distant recurrence to inform adjuvant treatment decisions in certain women with early-stage invasive breast cancer. Oncotype DX test results assign a Recurrence Score, and the Oncotype DX Recurrence Score is a continuous score, ranged between 0 and 100, that provides an individual estimate of the 10 year risk of distant recurrence and predicts the likelihood of benefit from chemotherapy. Higher score indicate higher risk of recurrence.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Recurrence score
    unit Of Measure
    Participants
population Description
All eligible patients who had on-study data and follow-up data were included in the analysis

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Preserved source evidence · Not medical advice