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NCT04439136 · FLOW

Participant flow

Testing Afatinib as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol B) · Source last updated 2026-09-08

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

groups
  1. description
    Patients receive afatinib dimaleate 40mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Afatinib Dimaleate: Given PO
    id
    FG000
    title
    Treatment (Afatinib Dimaleate)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Ineligible
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Never Started Treatment
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        27
      type
      Disease Progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Alternative Therapy
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Increased Tumor Burden
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Symptomatic Detrioration
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        40
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        39
      type
      Eligible
    3. achievements
      1. group Id
        FG000
        num Subjects
        37
      comment
      One patient ineligible, 2 patients never started treatment. This is the primary analysis population.
      type
      Eligible and Started Protocol Therapy
    4. achievements
      1. group Id
        FG000
        num Subjects
        37
      comment
      Excluding two who did not receive afatinib treatment and one who was not assessed for toxicity
      type
      Reported Adverse Events Data
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      comment
      Treatment continued until disease progression or intolerability.
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        40
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
To be assigned to a specific MATCH subprotocol, patients needed to submit a tumor biopsy for molecular characterization and those with molecular variants addressed by treatments included in the trial entered corresponding MATCH subprotocol. For the subprotocol B, patients had to have a qualifying ERBB2 actionable mutation.
recruitment Details
Subprotocol B was activated on August 12, 2015. Fifty-nine patients were assigned to Subprotocol B after screening, all from screening cohort. Of the 59 patients, 40 patients were enrolled in arm B between August 2015 and June 2017.
Complete source fields
groups
  1. description
    Patients receive afatinib dimaleate 40mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Afatinib Dimaleate: Given PO
    id
    FG000
    title
    Treatment (Afatinib Dimaleate)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Ineligible
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Never Started Treatment
    3. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        27
      type
      Disease Progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Alternative Therapy
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Increased Tumor Burden
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Symptomatic Detrioration
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        40
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        39
      type
      Eligible
    3. achievements
      1. group Id
        FG000
        num Subjects
        37
      comment
      One patient ineligible, 2 patients never started treatment. This is the primary analysis population.
      type
      Eligible and Started Protocol Therapy
    4. achievements
      1. group Id
        FG000
        num Subjects
        37
      comment
      Excluding two who did not receive afatinib treatment and one who was not assessed for toxicity
      type
      Reported Adverse Events Data
    5. achievements
      1. group Id
        FG000
        num Subjects
        0
      comment
      Treatment continued until disease progression or intolerability.
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        40
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
To be assigned to a specific MATCH subprotocol, patients needed to submit a tumor biopsy for molecular characterization and those with molecular variants addressed by treatments included in the trial entered corresponding MATCH subprotocol. For the subprotocol B, patients had to have a qualifying ERBB2 actionable mutation.
recruitment Details
Subprotocol B was activated on August 12, 2015. Fifty-nine patients were assigned to Subprotocol B after screening, all from screening cohort. Of the 59 patients, 40 patients were enrolled in arm B between August 2015 and June 2017.

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Preserved source evidence · Not medical advice