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NCT03493854 · BASELINE

Baseline characteristics

A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer · Source last updated 2024-06-26

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
      252
    2. group Id
      BG001
      value
      248
    3. group Id
      BG002
      value
      500
    units
    Participants
groups
  1. description
    Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks (Q2W) (given with granulocyte colony-stimulating factor \[G-CSF\] support as needed according to local guidelines) followed by paclitaxel QW for 12 weeks; or 2) 4 cycles of doxorubicin plus cyclophosphamide (AC) once every 3 weeks (Q3W) followed by docetaxel Q3W for 4 cycles. Pertuzumab and trastuzumab were given intravenously (IV) for 4 cycles Q3W concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of pertuzumab IV and trastuzumab IV for a total of 18 cycles.
    id
    BG000
    title
    Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy
  2. description
    Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles.
    id
    BG001
    title
    Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.8
          value
          50.3
        2. group Id
          BG001
          spread
          10.7
          value
          51.7
        3. group Id
          BG002
          spread
          10.8
          value
          51.0
    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
          250
        2. group Id
          BG001
          value
          248
        3. group Id
          BG002
          value
          498
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        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
          32
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          74
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          200
        2. group Id
          BG001
          value
          189
        3. group Id
          BG002
          value
          389
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          37
        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
          10
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          20
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          105
        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
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          164
        2. group Id
          BG001
          value
          165
        3. group Id
          BG002
          value
          329
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          35
        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
          value
          97
        2. group Id
          BG001
          value
          96
        3. group Id
          BG002
          value
          193
        title
        ER Negative and PgR Negative
      2. measurements
        1. group Id
          BG000
          value
          155
        2. group Id
          BG001
          value
          151
        3. group Id
          BG002
          value
          306
        title
        ER Positive and PgR Positive
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Unknown
    description
    Hormone receptor status was based on central assessment of participant samples for estrogen receptor (ER) and progesterone receptor (PgR) negativity or positivity.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Randomization Stratification Factors: Hormone Receptor Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          201
        2. group Id
          BG001
          value
          198
        3. group Id
          BG002
          value
          399
        title
        Stage II-IIIA
      2. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          101
        title
        Stage IIIB-IIIC
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Randomization Stratification Factors: Clinical Stage at Presentation
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          120
        2. group Id
          BG001
          value
          120
        3. group Id
          BG002
          value
          240
        title
        ddAC Followed by Paclitaxel
      2. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          128
        3. group Id
          BG002
          value
          260
        title
        AC Followed by Docetaxel
    description
    AC = doxorubicin plus cyclophosphamide; ddAC = dose-dense doxorubicin plus cyclophosphamide
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Randomization Stratification Factors: Neoadjuvant Chemotherapy Regimen
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      252
    2. group Id
      BG001
      value
      248
    3. group Id
      BG002
      value
      500
    units
    Participants
groups
  1. description
    Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks (Q2W) (given with granulocyte colony-stimulating factor \[G-CSF\] support as needed according to local guidelines) followed by paclitaxel QW for 12 weeks; or 2) 4 cycles of doxorubicin plus cyclophosphamide (AC) once every 3 weeks (Q3W) followed by docetaxel Q3W for 4 cycles. Pertuzumab and trastuzumab were given intravenously (IV) for 4 cycles Q3W concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of pertuzumab IV and trastuzumab IV for a total of 18 cycles.
    id
    BG000
    title
    Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy
  2. description
    Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles.
    id
    BG001
    title
    Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.8
          value
          50.3
        2. group Id
          BG001
          spread
          10.7
          value
          51.7
        3. group Id
          BG002
          spread
          10.8
          value
          51.0
    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
          250
        2. group Id
          BG001
          value
          248
        3. group Id
          BG002
          value
          498
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        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
          32
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          74
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          200
        2. group Id
          BG001
          value
          189
        3. group Id
          BG002
          value
          389
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          37
        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
          10
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          20
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          105
        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
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          164
        2. group Id
          BG001
          value
          165
        3. group Id
          BG002
          value
          329
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          35
        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
          value
          97
        2. group Id
          BG001
          value
          96
        3. group Id
          BG002
          value
          193
        title
        ER Negative and PgR Negative
      2. measurements
        1. group Id
          BG000
          value
          155
        2. group Id
          BG001
          value
          151
        3. group Id
          BG002
          value
          306
        title
        ER Positive and PgR Positive
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Unknown
    description
    Hormone receptor status was based on central assessment of participant samples for estrogen receptor (ER) and progesterone receptor (PgR) negativity or positivity.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Randomization Stratification Factors: Hormone Receptor Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          201
        2. group Id
          BG001
          value
          198
        3. group Id
          BG002
          value
          399
        title
        Stage II-IIIA
      2. measurements
        1. group Id
          BG000
          value
          51
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          101
        title
        Stage IIIB-IIIC
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Randomization Stratification Factors: Clinical Stage at Presentation
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          120
        2. group Id
          BG001
          value
          120
        3. group Id
          BG002
          value
          240
        title
        ddAC Followed by Paclitaxel
      2. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          128
        3. group Id
          BG002
          value
          260
        title
        AC Followed by Docetaxel
    description
    AC = doxorubicin plus cyclophosphamide; ddAC = dose-dense doxorubicin plus cyclophosphamide
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Randomization Stratification Factors: Neoadjuvant Chemotherapy Regimen
    unit Of Measure
    Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice