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NCT02132949 · FLOW

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A Study Evaluating Pertuzumab (Perjeta) Combined With Trastuzumab (Herceptin) and Standard Anthracycline-based Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced, Inflammatory, or Early-stage Breast Cancer · Source last updated 2021-09-17

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Participants received neoadjuvant treatment with dose-dense doxorubicin and cyclophosphamide (ddAC), with administration of doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously (IV) once every 2 weeks (q2w) and cyclophosphamide 600mg/m\^2 IV q2w for 4 cycles, followed by paclitaxel 80mg/m\^2 IV once weekly (qw) for 12 weeks. Pertuzumab (840 milligrams \[mg\] IV loading dose then 420mg IV q3w) and trastuzumab (8 milligrams per kilogram \[mg/kg\] IV loading dose then 4mg/kg IV q3w) were administered along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.
    id
    FG000
    title
    Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab
  2. description
    Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m\^2 intravenously (IV) q3w, epirubicin 100mg/m\^2 IV q3w, and cyclophosphamide 600mg/m\^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m\^2 in Cycle 5, then 100mg/m\^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.
    id
    FG001
    title
    Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        13
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        4
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        5
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      type
      Noncompliance
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      type
      Disease Progression
    7. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Adverse Event
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrew Prior to Treatment
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Reason Unspecified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        199
      2. comment
        1 participant enrolled in Cohort B received Cohort A treatment (and was counted as part of Cohort B for efficacy).
        group Id
        FG001
        num Subjects
        201
      comment
      ITT Population
      type
      STARTED
    2. achievements
      1. comment
        1 participant withdrew prior to receiving any study drug.
        group Id
        FG000
        num Subjects
        198
      2. comment
        1 participant enrolled in Cohort B received Cohort A treatment (and was counted as part of Cohort A for safety).
        group Id
        FG001
        num Subjects
        1
      comment
      Safety Population for Cohort A
      type
      Received Any Cohort A Study Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        2 participants withdrew prior to receiving any study drug.
        group Id
        FG001
        num Subjects
        198
      comment
      Safety Population for Cohort B
      type
      Received Any Cohort B Study Treatment
    4. achievements
      1. group Id
        FG000
        num Subjects
        187
      2. group Id
        FG001
        num Subjects
        194
      type
      Underwent Surgery
    5. achievements
      1. group Id
        FG000
        num Subjects
        182
      2. group Id
        FG001
        num Subjects
        189
      type
      Completed Neoadjuvant Treatment (25 Weeks)
    6. achievements
      1. group Id
        FG000
        num Subjects
        181
      2. comment
        1 participant did not complete neoadjuvant treatment but started adjuvant treatment.
        group Id
        FG001
        num Subjects
        190
      type
      Started Adjuvant Treatment
    7. achievements
      1. group Id
        FG000
        num Subjects
        163
      2. group Id
        FG001
        num Subjects
        176
      type
      Completed Adjuvant Treatment (Up to 39 Weeks)
    8. achievements
      1. group Id
        FG000
        num Subjects
        195
      2. group Id
        FG001
        num Subjects
        195
      comment
      Includes participants who completed or discontinued neoadjuvant/adjuvant treatment.
      type
      Started Treatment-Free Follow-Up (Up to 5 Years)
    9. achievements
      1. group Id
        FG000
        num Subjects
        158
      2. group Id
        FG001
        num Subjects
        173
      type
      COMPLETED
    10. achievements
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        28
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 401 participants were enrolled, 199 in Cohort A and 202 in Cohort B. One participant in Cohort B who was human epidermal growth factor receptor 2 (HER2) negative and was enrolled by error, was excluded. Hence, 199 participants were included in Cohort A and 201 participants in Cohort B.
Complete source fields
groups
  1. description
    Participants received neoadjuvant treatment with dose-dense doxorubicin and cyclophosphamide (ddAC), with administration of doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously (IV) once every 2 weeks (q2w) and cyclophosphamide 600mg/m\^2 IV q2w for 4 cycles, followed by paclitaxel 80mg/m\^2 IV once weekly (qw) for 12 weeks. Pertuzumab (840 milligrams \[mg\] IV loading dose then 420mg IV q3w) and trastuzumab (8 milligrams per kilogram \[mg/kg\] IV loading dose then 4mg/kg IV q3w) were administered along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.
    id
    FG000
    title
    Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab
  2. description
    Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m\^2 intravenously (IV) q3w, epirubicin 100mg/m\^2 IV q3w, and cyclophosphamide 600mg/m\^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m\^2 in Cycle 5, then 100mg/m\^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.
    id
    FG001
    title
    Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        13
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        4
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        5
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      type
      Noncompliance
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      type
      Disease Progression
    7. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Adverse Event
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      Withdrew Prior to Treatment
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Reason Unspecified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        199
      2. comment
        1 participant enrolled in Cohort B received Cohort A treatment (and was counted as part of Cohort B for efficacy).
        group Id
        FG001
        num Subjects
        201
      comment
      ITT Population
      type
      STARTED
    2. achievements
      1. comment
        1 participant withdrew prior to receiving any study drug.
        group Id
        FG000
        num Subjects
        198
      2. comment
        1 participant enrolled in Cohort B received Cohort A treatment (and was counted as part of Cohort A for safety).
        group Id
        FG001
        num Subjects
        1
      comment
      Safety Population for Cohort A
      type
      Received Any Cohort A Study Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. comment
        2 participants withdrew prior to receiving any study drug.
        group Id
        FG001
        num Subjects
        198
      comment
      Safety Population for Cohort B
      type
      Received Any Cohort B Study Treatment
    4. achievements
      1. group Id
        FG000
        num Subjects
        187
      2. group Id
        FG001
        num Subjects
        194
      type
      Underwent Surgery
    5. achievements
      1. group Id
        FG000
        num Subjects
        182
      2. group Id
        FG001
        num Subjects
        189
      type
      Completed Neoadjuvant Treatment (25 Weeks)
    6. achievements
      1. group Id
        FG000
        num Subjects
        181
      2. comment
        1 participant did not complete neoadjuvant treatment but started adjuvant treatment.
        group Id
        FG001
        num Subjects
        190
      type
      Started Adjuvant Treatment
    7. achievements
      1. group Id
        FG000
        num Subjects
        163
      2. group Id
        FG001
        num Subjects
        176
      type
      Completed Adjuvant Treatment (Up to 39 Weeks)
    8. achievements
      1. group Id
        FG000
        num Subjects
        195
      2. group Id
        FG001
        num Subjects
        195
      comment
      Includes participants who completed or discontinued neoadjuvant/adjuvant treatment.
      type
      Started Treatment-Free Follow-Up (Up to 5 Years)
    9. achievements
      1. group Id
        FG000
        num Subjects
        158
      2. group Id
        FG001
        num Subjects
        173
      type
      COMPLETED
    10. achievements
      1. group Id
        FG000
        num Subjects
        41
      2. group Id
        FG001
        num Subjects
        28
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 401 participants were enrolled, 199 in Cohort A and 202 in Cohort B. One participant in Cohort B who was human epidermal growth factor receptor 2 (HER2) negative and was enrolled by error, was excluded. Hence, 199 participants were included in Cohort A and 201 participants in Cohort B.

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

Preserved source evidence · Not medical advice