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NCT03493854 · FLOW

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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.

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 (neo)adjuvant anti-HER2 treatment cycles.
    id
    FG000
    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 (neo)adjuvant anti-HER2 treatment cycles.
    id
    FG001
    title
    Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Protocol Violation
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      type
      Progressive Disease
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Other
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Other
    milestones
    1. achievements
      1. comment
        This includes all randomized participants.
        group Id
        FG000
        num Subjects
        252
      2. comment
        This includes all randomized participants.
        group Id
        FG001
        num Subjects
        248
      comment
      Intent-to-Treat (ITT) Population
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        252
      2. group Id
        FG001
        num Subjects
        248
      comment
      Safety Population
      type
      Received at Least One Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        242
      2. group Id
        FG001
        num Subjects
        234
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        14
      type
      NOT COMPLETED
    title
    Neoadjuvant Treatment Phase (24 Weeks)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        7
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Lack of Efficacy
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      type
      Progressive Disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        2
      type
      Other
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    7. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      type
      Physician Decision
    8. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      type
      Disease Relapse
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        242
      2. group Id
        FG001
        num Subjects
        234
      comment
      Completed Neoadjuvant Treatment Phase
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        239
      2. group Id
        FG001
        num Subjects
        234
      type
      Completed Surgery
    3. achievements
      1. group Id
        FG000
        num Subjects
        209
      2. group Id
        FG001
        num Subjects
        217
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        33
      2. group Id
        FG001
        num Subjects
        17
      type
      NOT COMPLETED
    title
    Surgery & Adjuvant Treatment (42 Weeks)
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        11
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        10
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. comment
        In addition to participants who completed the previous periods, those who prematurely withdrew from (neo)adjuvant treatment entered the follow-up phase.
        group Id
        FG000
        num Subjects
        247
      2. comment
        In addition to participants who completed the previous periods, those who prematurely withdrew from (neo)adjuvant treatment entered the follow-up phase.
        group Id
        FG001
        num Subjects
        241
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        223
      2. group Id
        FG001
        num Subjects
        219
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        22
      type
      NOT COMPLETED
    title
    Treatment-Free Follow-Up (up to 3 Years)
pre Assignment Details
A total of 607 patients were screened, 500 of whom were randomized.
Complete source fields
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 (neo)adjuvant anti-HER2 treatment cycles.
    id
    FG000
    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 (neo)adjuvant anti-HER2 treatment cycles.
    id
    FG001
    title
    Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Protocol Violation
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      type
      Progressive Disease
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Other
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Other
    milestones
    1. achievements
      1. comment
        This includes all randomized participants.
        group Id
        FG000
        num Subjects
        252
      2. comment
        This includes all randomized participants.
        group Id
        FG001
        num Subjects
        248
      comment
      Intent-to-Treat (ITT) Population
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        252
      2. group Id
        FG001
        num Subjects
        248
      comment
      Safety Population
      type
      Received at Least One Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        242
      2. group Id
        FG001
        num Subjects
        234
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        14
      type
      NOT COMPLETED
    title
    Neoadjuvant Treatment Phase (24 Weeks)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        7
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Lack of Efficacy
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      type
      Progressive Disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        2
      type
      Other
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    7. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      type
      Physician Decision
    8. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      type
      Disease Relapse
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        242
      2. group Id
        FG001
        num Subjects
        234
      comment
      Completed Neoadjuvant Treatment Phase
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        239
      2. group Id
        FG001
        num Subjects
        234
      type
      Completed Surgery
    3. achievements
      1. group Id
        FG000
        num Subjects
        209
      2. group Id
        FG001
        num Subjects
        217
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        33
      2. group Id
        FG001
        num Subjects
        17
      type
      NOT COMPLETED
    title
    Surgery & Adjuvant Treatment (42 Weeks)
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        11
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        10
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. comment
        In addition to participants who completed the previous periods, those who prematurely withdrew from (neo)adjuvant treatment entered the follow-up phase.
        group Id
        FG000
        num Subjects
        247
      2. comment
        In addition to participants who completed the previous periods, those who prematurely withdrew from (neo)adjuvant treatment entered the follow-up phase.
        group Id
        FG001
        num Subjects
        241
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        223
      2. group Id
        FG001
        num Subjects
        219
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        22
      type
      NOT COMPLETED
    title
    Treatment-Free Follow-Up (up to 3 Years)
pre Assignment Details
A total of 607 patients were screened, 500 of whom were randomized.

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Preserved source evidence · Not medical advice