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NCT03674112 · BASELINE

Baseline characteristics

A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer · Source last updated 2024-01-02

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
      80
    2. group Id
      BG001
      value
      80
    3. group Id
      BG002
      value
      160
    units
    Participants
groups
  1. description
    In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received pertuzumab IV and trastuzumab IV (P+H IV) administration for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
    id
    BG000
    title
    A: P+H IV Followed by PH FDC SC
  2. description
    In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles followed by pertuzumab intravenous (IV) and trastuzumab IV (P+H IV) administration for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
    id
    BG001
    title
    B: PH FDC SC Followed by P+H IV
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.6
          value
          49.4
        2. group Id
          BG001
          spread
          12.1
          value
          48.2
        3. group Id
          BG002
          spread
          11.8
          value
          48.8
    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
          80
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          160
        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
          17
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          38
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          59
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          113
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          9
        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
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          12
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          62
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          129
        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
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.08
          value
          67.36
        2. group Id
          BG001
          spread
          14.15
          value
          70.21
        3. group Id
          BG002
          spread
          13.20
          value
          68.78
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Baseline Weight
    unit Of Measure
    kilograms (kg)
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          140
        title
        ECOG Peformance Status 0
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          20
        title
        ECOG Peformance Status 1
    description
    ECOG Performance Status: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework or office work.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          15
        title
        <4 Cycles
      2. measurements
        1. group Id
          BG000
          value
          75
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          145
        title
        ≥4 Cycles
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Cycles of Prior Neoadjuvant Pertuzumab IV and Trastuzumab IV
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          55
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          108
        title
        Anthracyclines + Taxanes
      2. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          45
        title
        Carboplatin + Taxanes
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        Taxanes Only
    description
    Participants were stratified at randomization according to prior neoadjuvant chemotherapy regimen, pathological complete response to prior neoadjuvant treatment, and hormone receptor status.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Neoadjuvant Chemotherapy Regimen
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          102
        title
        pCR
      2. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          58
        title
        Non-pCR
    description
    Participants were stratified at randomization according to prior neoadjuvant chemotherapy regimen, pathological complete response to prior neoadjuvant treatment, and hormone receptor status.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Pathological Complete Response (pCR) to Prior Neoadjuvant Treatment
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          104
        title
        Estrogen Receptor (ER)-Positive and/or Progesterone Receptor (PgR)-Positive
      2. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          56
        title
        ER-Negative and PgR-Negative
    description
    Participants were stratified at randomization according to prior neoadjuvant chemotherapy regimen, pathological complete response to prior neoadjuvant treatment, and hormone receptor status.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Hormone Receptor Status
    unit Of Measure
    Participants
population Description
Intent-to-Treat (ITT) Population: includes all randomized participants, allocated to their randomized treatment arm, whether or not the assigned study treatment was received.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      80
    2. group Id
      BG001
      value
      80
    3. group Id
      BG002
      value
      160
    units
    Participants
groups
  1. description
    In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received pertuzumab IV and trastuzumab IV (P+H IV) administration for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
    id
    BG000
    title
    A: P+H IV Followed by PH FDC SC
  2. description
    In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles followed by pertuzumab intravenous (IV) and trastuzumab IV (P+H IV) administration for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
    id
    BG001
    title
    B: PH FDC SC Followed by P+H IV
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.6
          value
          49.4
        2. group Id
          BG001
          spread
          12.1
          value
          48.2
        3. group Id
          BG002
          spread
          11.8
          value
          48.8
    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
          80
        2. group Id
          BG001
          value
          80
        3. group Id
          BG002
          value
          160
        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
          17
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          38
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          59
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          113
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          9
        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
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          12
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          62
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          129
        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
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.08
          value
          67.36
        2. group Id
          BG001
          spread
          14.15
          value
          70.21
        3. group Id
          BG002
          spread
          13.20
          value
          68.78
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Baseline Weight
    unit Of Measure
    kilograms (kg)
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          140
        title
        ECOG Peformance Status 0
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          20
        title
        ECOG Peformance Status 1
    description
    ECOG Performance Status: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework or office work.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          15
        title
        <4 Cycles
      2. measurements
        1. group Id
          BG000
          value
          75
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          145
        title
        ≥4 Cycles
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Cycles of Prior Neoadjuvant Pertuzumab IV and Trastuzumab IV
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          55
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          108
        title
        Anthracyclines + Taxanes
      2. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          45
        title
        Carboplatin + Taxanes
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        Taxanes Only
    description
    Participants were stratified at randomization according to prior neoadjuvant chemotherapy regimen, pathological complete response to prior neoadjuvant treatment, and hormone receptor status.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Neoadjuvant Chemotherapy Regimen
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          102
        title
        pCR
      2. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          58
        title
        Non-pCR
    description
    Participants were stratified at randomization according to prior neoadjuvant chemotherapy regimen, pathological complete response to prior neoadjuvant treatment, and hormone receptor status.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Pathological Complete Response (pCR) to Prior Neoadjuvant Treatment
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          104
        title
        Estrogen Receptor (ER)-Positive and/or Progesterone Receptor (PgR)-Positive
      2. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          56
        title
        ER-Negative and PgR-Negative
    description
    Participants were stratified at randomization according to prior neoadjuvant chemotherapy regimen, pathological complete response to prior neoadjuvant treatment, and hormone receptor status.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Hormone Receptor Status
    unit Of Measure
    Participants
population Description
Intent-to-Treat (ITT) Population: includes all randomized participants, allocated to their randomized treatment arm, whether or not the assigned study treatment was received.

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