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NCT03674112 · FLOW

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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.

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
    FG000
    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
    FG001
    title
    B: PH FDC SC Followed by P+H IV
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        80
      2. group Id
        FG001
        num Subjects
        80
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        80
      2. group Id
        FG001
        num Subjects
        80
      comment
      Received all 6 cycles of cross-over treatment
      type
      Completed Cross-Over Treatment
    3. achievements
      1. comment
        One participant discontinued the cross-over period after completing cross-over treatment (after receiving Cycle 6) and did not start treatment continuation. They entered directly into the follow-up period.
        group Id
        FG000
        num Subjects
        79
      2. group Id
        FG001
        num Subjects
        80
      comment
      Completed the Treatment Cross-Over Period
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Treatment Cross-Over (Cycles 1 to 6)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Reason Not Specified
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Disease Relapse
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        79
      2. group Id
        FG001
        num Subjects
        80
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        70
      2. group Id
        FG001
        num Subjects
        68
      type
      Received PH FDC SC for Treatment Continuation
    3. achievements
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        12
      type
      Received P+H IV for Treatment Continuation
    4. achievements
      1. group Id
        FG000
        num Subjects
        78
      2. comment
        One participant withdrew from the study during the continuation period (withdrawal by subject) and did not enter follow-up.
        group Id
        FG001
        num Subjects
        77
      comment
      Received all cycles of continuation treatment (from Cycle 7 up to 18 total cycles of neo/adjuvant treatment)
      type
      Completed Continuation Treatment
    5. achievements
      1. group Id
        FG000
        num Subjects
        78
      2. group Id
        FG001
        num Subjects
        77
      comment
      Completed the Treatment Continuation Period
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Treatment Continuation (Cycles 7 to ≤18)
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Reason Not Specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        80
      2. group Id
        FG001
        num Subjects
        79
      comment
      Participants who discontinued previous treatment periods but remained in the study continued into the follow-up period.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        73
      2. group Id
        FG001
        num Subjects
        75
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Follow-Up Period (≥3 Years)
recruitment Details
A total of 183 patients were screened and 160 participants were enrolled.
Complete source fields
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
    FG000
    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
    FG001
    title
    B: PH FDC SC Followed by P+H IV
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        80
      2. group Id
        FG001
        num Subjects
        80
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        80
      2. group Id
        FG001
        num Subjects
        80
      comment
      Received all 6 cycles of cross-over treatment
      type
      Completed Cross-Over Treatment
    3. achievements
      1. comment
        One participant discontinued the cross-over period after completing cross-over treatment (after receiving Cycle 6) and did not start treatment continuation. They entered directly into the follow-up period.
        group Id
        FG000
        num Subjects
        79
      2. group Id
        FG001
        num Subjects
        80
      comment
      Completed the Treatment Cross-Over Period
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Treatment Cross-Over (Cycles 1 to 6)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Reason Not Specified
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Disease Relapse
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        79
      2. group Id
        FG001
        num Subjects
        80
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        70
      2. group Id
        FG001
        num Subjects
        68
      type
      Received PH FDC SC for Treatment Continuation
    3. achievements
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        12
      type
      Received P+H IV for Treatment Continuation
    4. achievements
      1. group Id
        FG000
        num Subjects
        78
      2. comment
        One participant withdrew from the study during the continuation period (withdrawal by subject) and did not enter follow-up.
        group Id
        FG001
        num Subjects
        77
      comment
      Received all cycles of continuation treatment (from Cycle 7 up to 18 total cycles of neo/adjuvant treatment)
      type
      Completed Continuation Treatment
    5. achievements
      1. group Id
        FG000
        num Subjects
        78
      2. group Id
        FG001
        num Subjects
        77
      comment
      Completed the Treatment Continuation Period
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Treatment Continuation (Cycles 7 to ≤18)
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Reason Not Specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        80
      2. group Id
        FG001
        num Subjects
        79
      comment
      Participants who discontinued previous treatment periods but remained in the study continued into the follow-up period.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        73
      2. group Id
        FG001
        num Subjects
        75
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Follow-Up Period (≥3 Years)
recruitment Details
A total of 183 patients were screened and 160 participants were enrolled.

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Preserved source evidence · Not medical advice