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NCT01772472 · FLOW

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A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE) · Source last updated 2025-07-22

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

groups
  1. description
    Participants received trastuzumab, 6 milligram per kilograms (mg/kg), intravenously (IV), every 3 weeks (Q3W), as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
    id
    FG000
    title
    Trastuzumab
  2. description
    Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
    id
    FG001
    title
    Trastuzumab Emtansine
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        126
      2. group Id
        FG001
        num Subjects
        94
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        51
      2. group Id
        FG001
        num Subjects
        50
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        7
      type
      Other
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        7
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        115
      2. group Id
        FG001
        num Subjects
        90
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        441
      2. group Id
        FG001
        num Subjects
        495
      type
      Follow-up Terminated by Sponsor
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        743
      2. group Id
        FG001
        num Subjects
        743
      type
      STARTED
    2. achievements
      1. comment
        1 participant in trastuzumab emtansine arm received 9 cycles of trastuzumab \& included in trastuzumab safety analysis.
        group Id
        FG000
        num Subjects
        720
      2. comment
        1 participant randomized to trastuzumab arm was untreated, later re-randomized to trastuzumab emtansine arm \& received treatment. Another participant in the trastuzumab arm received 13 cycles of trastuzumab \& 1 of trastuzumab emtansine. Both these participants were included in the trastuzumab emtansine safety analysis.
        group Id
        FG001
        num Subjects
        740
      comment
      SE population included all randomized participants who received any amount of study treatment.
      type
      Safety-evaluable (SE) Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        743
      2. group Id
        FG001
        num Subjects
        743
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants received either trastuzumab or trastuzumab emtansine (T-DM1). 1 participant randomized to trastuzumab arm was untreated, later re-randomized to T-DM1 arm \& received treatment. Another participant in the trastuzumab arm received 13 cycles of trastuzumab \& 1 of T-DM1. Both these participants were included in the trastuzumab ITT population and T-DM1 safety analysis. 1 participant in T-DM1 arm received 9 cycles of trastuzumab \& included in trastuzumab safety analysis.
recruitment Details
A total of 1486 participants with human epidermal growth factor receptor 2 (HER2)-positive primary breast cancer who had residual invasive disease in either the breast or axillary lymph nodes took part in the study at 268 investigative sites across 28 countries from April 03, 2013 to May 23, 2024.
Complete source fields
groups
  1. description
    Participants received trastuzumab, 6 milligram per kilograms (mg/kg), intravenously (IV), every 3 weeks (Q3W), as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
    id
    FG000
    title
    Trastuzumab
  2. description
    Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
    id
    FG001
    title
    Trastuzumab Emtansine
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        126
      2. group Id
        FG001
        num Subjects
        94
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        51
      2. group Id
        FG001
        num Subjects
        50
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        7
      type
      Other
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        7
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        115
      2. group Id
        FG001
        num Subjects
        90
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        441
      2. group Id
        FG001
        num Subjects
        495
      type
      Follow-up Terminated by Sponsor
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        743
      2. group Id
        FG001
        num Subjects
        743
      type
      STARTED
    2. achievements
      1. comment
        1 participant in trastuzumab emtansine arm received 9 cycles of trastuzumab \& included in trastuzumab safety analysis.
        group Id
        FG000
        num Subjects
        720
      2. comment
        1 participant randomized to trastuzumab arm was untreated, later re-randomized to trastuzumab emtansine arm \& received treatment. Another participant in the trastuzumab arm received 13 cycles of trastuzumab \& 1 of trastuzumab emtansine. Both these participants were included in the trastuzumab emtansine safety analysis.
        group Id
        FG001
        num Subjects
        740
      comment
      SE population included all randomized participants who received any amount of study treatment.
      type
      Safety-evaluable (SE) Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        743
      2. group Id
        FG001
        num Subjects
        743
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants received either trastuzumab or trastuzumab emtansine (T-DM1). 1 participant randomized to trastuzumab arm was untreated, later re-randomized to T-DM1 arm \& received treatment. Another participant in the trastuzumab arm received 13 cycles of trastuzumab \& 1 of T-DM1. Both these participants were included in the trastuzumab ITT population and T-DM1 safety analysis. 1 participant in T-DM1 arm received 9 cycles of trastuzumab \& included in trastuzumab safety analysis.
recruitment Details
A total of 1486 participants with human epidermal growth factor receptor 2 (HER2)-positive primary breast cancer who had residual invasive disease in either the breast or axillary lymph nodes took part in the study at 268 investigative sites across 28 countries from April 03, 2013 to May 23, 2024.

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

Preserved source evidence · Not medical advice