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NCT01808573 · FLOW

Participant flow

A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting · Source last updated 2021-06-11

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

groups
  1. description
    neratinib 240 mg orally, once daily with food, continuously in 21 day cycles, and capecitabine 1500 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
    id
    FG000
    title
    Neratinib Plus Capecitabine
  2. description
    lapatinib 1250 mg orally, once daily, continuously in 21 day cycles, and capecitabine 2000 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
    id
    FG001
    title
    Lapatinib Plus Capecitabine
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        212
      2. group Id
        FG001
        num Subjects
        240
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        10
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        79
      2. group Id
        FG001
        num Subjects
        64
      type
      Discontinuation of study by sponsor
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Randomized in Error
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        307
      2. group Id
        FG001
        num Subjects
        314
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        303
      2. group Id
        FG001
        num Subjects
        311
      type
      Received Treatment
    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
        307
      2. group Id
        FG001
        num Subjects
        314
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    neratinib 240 mg orally, once daily with food, continuously in 21 day cycles, and capecitabine 1500 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
    id
    FG000
    title
    Neratinib Plus Capecitabine
  2. description
    lapatinib 1250 mg orally, once daily, continuously in 21 day cycles, and capecitabine 2000 mg/m\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
    id
    FG001
    title
    Lapatinib Plus Capecitabine
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        212
      2. group Id
        FG001
        num Subjects
        240
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        10
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        79
      2. group Id
        FG001
        num Subjects
        64
      type
      Discontinuation of study by sponsor
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Randomized in Error
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        307
      2. group Id
        FG001
        num Subjects
        314
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        303
      2. group Id
        FG001
        num Subjects
        311
      type
      Received Treatment
    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
        307
      2. group Id
        FG001
        num Subjects
        314
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice