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NCT01358877 · BASELINE

Baseline characteristics

A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer · Source last updated 2025-11-28

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
      2400
    2. group Id
      BG001
      value
      2404
    3. group Id
      BG002
      value
      4804
    units
    Participants
groups
  1. description
    Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
    id
    BG000
    title
    Pertuzumab + Trastuzumab + Chemotherapy
  2. description
    Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
    id
    BG001
    title
    Placebo + Trastuzumab + Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.9
          value
          51.7
        2. group Id
          BG001
          spread
          10.7
          value
          51.4
        3. group Id
          BG002
          spread
          10.8
          value
          51.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2397
        2. group Id
          BG001
          value
          2396
        3. group Id
          BG002
          value
          4793
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          11
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    ITT population
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          87
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          432
        2. group Id
          BG001
          value
          386
        3. group Id
          BG002
          value
          818
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1923
        2. group Id
          BG001
          value
          1976
        3. group Id
          BG002
          value
          3899
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1705
        2. group Id
          BG001
          value
          1694
        3. group Id
          BG002
          value
          3399
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          73
        title
        Black
      3. measurements
        1. group Id
          BG000
          value
          590
        2. group Id
          BG001
          value
          598
        3. group Id
          BG002
          value
          1188
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          69
        3. group Id
          BG002
          value
          135
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
        title
        Not reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          90
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          174
        title
        0 Positive Nodes and Tumor ≤1 cm
      2. measurements
        1. group Id
          BG000
          value
          807
        2. group Id
          BG001
          value
          818
        3. group Id
          BG002
          value
          1625
        title
        0 Positive Nodes and Tumor >1 cm
      3. measurements
        1. group Id
          BG000
          value
          907
        2. group Id
          BG001
          value
          900
        3. group Id
          BG002
          value
          1807
        title
        1 to 3 Positive Nodes
      4. measurements
        1. group Id
          BG000
          value
          596
        2. group Id
          BG001
          value
          602
        3. group Id
          BG002
          value
          1198
        title
        ≥4 Positive Nodes
    description
    The disease status of a participant's lymph nodes (positive or negative and number affected) was one of the study's randomization stratification factors. Nodal status may have taken any of the four categories for participants who enrolled under protocol version A, but only the two categories with positive nodes after protocol version B had been implemented.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Nodal Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1865
        2. group Id
          BG001
          value
          1877
        3. group Id
          BG002
          value
          3742
        title
        Anthracycline containing regimen
      2. measurements
        1. group Id
          BG000
          value
          535
        2. group Id
          BG001
          value
          527
        3. group Id
          BG002
          value
          1062
        title
        Non-anthracycline containing regimen
    description
    The type of adjuvant chemotherapy regimen that the investigator chose for each participant's treatment (anthracycline or non-anthracycline containing regimen) was one of the study's randomization stratification factors.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Adjuvant Chemotherapy Regimen
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          864
        2. group Id
          BG001
          value
          858
        3. group Id
          BG002
          value
          1722
        title
        Negative (ER and PgR negative)
      2. measurements
        1. group Id
          BG000
          value
          1536
        2. group Id
          BG001
          value
          1546
        3. group Id
          BG002
          value
          3082
        title
        Positive (ER and/or PgR positive)
    description
    Central laboratory assessment of the hormone receptor status (estrogen receptor \[ER\] and progesterone receptor \[PgR\] positive or negative) of each participant's tumor tissue sample was conducted at screening. The hormone receptor status was one of the study's randomization stratification factors.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Hormone Receptor Status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1828
        2. group Id
          BG001
          value
          1827
        3. group Id
          BG002
          value
          3655
        title
        Protocol Version A
      2. measurements
        1. group Id
          BG000
          value
          572
        2. group Id
          BG001
          value
          577
        3. group Id
          BG002
          value
          1149
        title
        Protocol Version B
    description
    The protocol version at enrollment (Version A or B) was one of the study's randomization stratification factors. The amendment from protocol version A (28-June-2011) to version B (20-Nov-2012) was made mainly to adjust for a higher than expected rate of recruitment of node-negative patients. Therefore, the trial sample size was increased from N=3806 to N=4800 and node-negative patients were no longer permitted to enroll.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Protocol Version at Enrollment
    unit Of Measure
    Participants
population Description
Intent-to-treat (ITT) population included all randomized participants regardless of treatment received.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      2400
    2. group Id
      BG001
      value
      2404
    3. group Id
      BG002
      value
      4804
    units
    Participants
groups
  1. description
    Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
    id
    BG000
    title
    Pertuzumab + Trastuzumab + Chemotherapy
  2. description
    Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 mg).
    id
    BG001
    title
    Placebo + Trastuzumab + Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.9
          value
          51.7
        2. group Id
          BG001
          spread
          10.7
          value
          51.4
        3. group Id
          BG002
          spread
          10.8
          value
          51.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2397
        2. group Id
          BG001
          value
          2396
        3. group Id
          BG002
          value
          4793
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          11
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    ITT population
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          87
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          432
        2. group Id
          BG001
          value
          386
        3. group Id
          BG002
          value
          818
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1923
        2. group Id
          BG001
          value
          1976
        3. group Id
          BG002
          value
          3899
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1705
        2. group Id
          BG001
          value
          1694
        3. group Id
          BG002
          value
          3399
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          73
        title
        Black
      3. measurements
        1. group Id
          BG000
          value
          590
        2. group Id
          BG001
          value
          598
        3. group Id
          BG002
          value
          1188
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          69
        3. group Id
          BG002
          value
          135
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
        title
        Not reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          90
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          174
        title
        0 Positive Nodes and Tumor ≤1 cm
      2. measurements
        1. group Id
          BG000
          value
          807
        2. group Id
          BG001
          value
          818
        3. group Id
          BG002
          value
          1625
        title
        0 Positive Nodes and Tumor >1 cm
      3. measurements
        1. group Id
          BG000
          value
          907
        2. group Id
          BG001
          value
          900
        3. group Id
          BG002
          value
          1807
        title
        1 to 3 Positive Nodes
      4. measurements
        1. group Id
          BG000
          value
          596
        2. group Id
          BG001
          value
          602
        3. group Id
          BG002
          value
          1198
        title
        ≥4 Positive Nodes
    description
    The disease status of a participant's lymph nodes (positive or negative and number affected) was one of the study's randomization stratification factors. Nodal status may have taken any of the four categories for participants who enrolled under protocol version A, but only the two categories with positive nodes after protocol version B had been implemented.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Nodal Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1865
        2. group Id
          BG001
          value
          1877
        3. group Id
          BG002
          value
          3742
        title
        Anthracycline containing regimen
      2. measurements
        1. group Id
          BG000
          value
          535
        2. group Id
          BG001
          value
          527
        3. group Id
          BG002
          value
          1062
        title
        Non-anthracycline containing regimen
    description
    The type of adjuvant chemotherapy regimen that the investigator chose for each participant's treatment (anthracycline or non-anthracycline containing regimen) was one of the study's randomization stratification factors.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Adjuvant Chemotherapy Regimen
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          864
        2. group Id
          BG001
          value
          858
        3. group Id
          BG002
          value
          1722
        title
        Negative (ER and PgR negative)
      2. measurements
        1. group Id
          BG000
          value
          1536
        2. group Id
          BG001
          value
          1546
        3. group Id
          BG002
          value
          3082
        title
        Positive (ER and/or PgR positive)
    description
    Central laboratory assessment of the hormone receptor status (estrogen receptor \[ER\] and progesterone receptor \[PgR\] positive or negative) of each participant's tumor tissue sample was conducted at screening. The hormone receptor status was one of the study's randomization stratification factors.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Hormone Receptor Status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1828
        2. group Id
          BG001
          value
          1827
        3. group Id
          BG002
          value
          3655
        title
        Protocol Version A
      2. measurements
        1. group Id
          BG000
          value
          572
        2. group Id
          BG001
          value
          577
        3. group Id
          BG002
          value
          1149
        title
        Protocol Version B
    description
    The protocol version at enrollment (Version A or B) was one of the study's randomization stratification factors. The amendment from protocol version A (28-June-2011) to version B (20-Nov-2012) was made mainly to adjust for a higher than expected rate of recruitment of node-negative patients. Therefore, the trial sample size was increased from N=3806 to N=4800 and node-negative patients were no longer permitted to enroll.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Protocol Version at Enrollment
    unit Of Measure
    Participants
population Description
Intent-to-treat (ITT) population included all randomized participants regardless of treatment received.

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Preserved source evidence · Not medical advice