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NCT04579380 · FLOW

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Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations · Source last updated 2026-08-21

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

groups
  1. description
    Participants with cervical cancer with HER2 amplification/over expression, received tucatinib 300 milligrams (mg) orally (PO) twice daily (BID) from Day 1 of Cycle 1 onwards and trastuzumab 8 milligram per kilograms (mg/kg) intravenously (IV) on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
    id
    FG000
    title
    Tucatinib+Trastuzumab (Cohort 1)
  2. description
    Participants with uterine cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
    id
    FG001
    title
    Tucatinib+Trastuzumab (Cohort 2)
  3. description
    Participants with biliary tract cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
    id
    FG002
    title
    Tucatinib+Trastuzumab (Cohort 3)
  4. description
    Participants with urothelial cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
    id
    FG003
    title
    Tucatinib+Trastuzumab (Cohort 4)
  5. description
    Participants with non-squamous non-small cell lung cancer (NSCLC) with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
    id
    FG004
    title
    Tucatinib+Trastuzumab (Cohort 5)
  6. description
    Participants with solid tumor types (except breast, gastric or gastroesophageal junction adenocarcinoma \[GEC\], and colorectal cancer \[CRC\]) with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
    id
    FG005
    title
    Tucatinib+Trastuzumab (Cohort 6)
  7. description
    Participants with non-squamous NSCLC with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
    id
    FG006
    title
    Tucatinib+Trastuzumab (Cohort 7)
  8. description
    Participants with breast cancer with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants with hormone-receptor positive breast cancer also received fulvestrant 500 mg intramuscular (IM) once every 4 weeks starting from Day 1 of Cycle 1, and on Day 15 of Cycle 1. Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
    id
    FG007
    title
    Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8)
  9. description
    Participants with all solid tumor cancers (except breast and non-squamous NSCLC) with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
    id
    FG008
    title
    Tucatinib+Trastuzumab (Cohort 9)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        22
      3. group Id
        FG002
        num Subjects
        22
      4. group Id
        FG003
        num Subjects
        17
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        21
      7. group Id
        FG006
        num Subjects
        10
      8. group Id
        FG007
        num Subjects
        11
      9. group Id
        FG008
        num Subjects
        25
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        2
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        8
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        19
      9. group Id
        FG008
        num Subjects
        6
      type
      Ongoing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        31
      3. group Id
        FG002
        num Subjects
        30
      4. group Id
        FG003
        num Subjects
        25
      5. group Id
        FG004
        num Subjects
        12
      6. group Id
        FG005
        num Subjects
        31
      7. group Id
        FG006
        num Subjects
        13
      8. group Id
        FG007
        num Subjects
        31
      9. group Id
        FG008
        num Subjects
        33
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        31
      3. group Id
        FG002
        num Subjects
        30
      4. group Id
        FG003
        num Subjects
        25
      5. group Id
        FG004
        num Subjects
        12
      6. group Id
        FG005
        num Subjects
        31
      7. group Id
        FG006
        num Subjects
        13
      8. group Id
        FG007
        num Subjects
        31
      9. group Id
        FG008
        num Subjects
        33
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 217 participants were enrolled into 9 separate cohorts based on tumor histology and HER2 alteration status. All 217 participants were treated. Results reported are based on the primary completion date (PCD) of the study; data for only those secondary outcome measures are reported for which analyses were complete at PCD. Remaining outcome measures would be reported upon completion of their analyses at study completion.
recruitment Details
Participants with locally-advanced (LA) unresectable or metastatic solid tumors driven by human epidermal growth factor receptor 2 (HER2) alterations, who were previously treated, were enrolled to receive tucatinib in combination with trastuzumab in this study. Participants with hormone-receptor positive breast cancer also received fulvestrant.
Complete source fields
groups
  1. description
    Participants with cervical cancer with HER2 amplification/over expression, received tucatinib 300 milligrams (mg) orally (PO) twice daily (BID) from Day 1 of Cycle 1 onwards and trastuzumab 8 milligram per kilograms (mg/kg) intravenously (IV) on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
    id
    FG000
    title
    Tucatinib+Trastuzumab (Cohort 1)
  2. description
    Participants with uterine cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
    id
    FG001
    title
    Tucatinib+Trastuzumab (Cohort 2)
  3. description
    Participants with biliary tract cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
    id
    FG002
    title
    Tucatinib+Trastuzumab (Cohort 3)
  4. description
    Participants with urothelial cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
    id
    FG003
    title
    Tucatinib+Trastuzumab (Cohort 4)
  5. description
    Participants with non-squamous non-small cell lung cancer (NSCLC) with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
    id
    FG004
    title
    Tucatinib+Trastuzumab (Cohort 5)
  6. description
    Participants with solid tumor types (except breast, gastric or gastroesophageal junction adenocarcinoma \[GEC\], and colorectal cancer \[CRC\]) with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
    id
    FG005
    title
    Tucatinib+Trastuzumab (Cohort 6)
  7. description
    Participants with non-squamous NSCLC with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
    id
    FG006
    title
    Tucatinib+Trastuzumab (Cohort 7)
  8. description
    Participants with breast cancer with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants with hormone-receptor positive breast cancer also received fulvestrant 500 mg intramuscular (IM) once every 4 weeks starting from Day 1 of Cycle 1, and on Day 15 of Cycle 1. Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
    id
    FG007
    title
    Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8)
  9. description
    Participants with all solid tumor cancers (except breast and non-squamous NSCLC) with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.
    id
    FG008
    title
    Tucatinib+Trastuzumab (Cohort 9)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        22
      3. group Id
        FG002
        num Subjects
        22
      4. group Id
        FG003
        num Subjects
        17
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        21
      7. group Id
        FG006
        num Subjects
        10
      8. group Id
        FG007
        num Subjects
        11
      9. group Id
        FG008
        num Subjects
        25
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        2
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        8
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        19
      9. group Id
        FG008
        num Subjects
        6
      type
      Ongoing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        31
      3. group Id
        FG002
        num Subjects
        30
      4. group Id
        FG003
        num Subjects
        25
      5. group Id
        FG004
        num Subjects
        12
      6. group Id
        FG005
        num Subjects
        31
      7. group Id
        FG006
        num Subjects
        13
      8. group Id
        FG007
        num Subjects
        31
      9. group Id
        FG008
        num Subjects
        33
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        31
      3. group Id
        FG002
        num Subjects
        30
      4. group Id
        FG003
        num Subjects
        25
      5. group Id
        FG004
        num Subjects
        12
      6. group Id
        FG005
        num Subjects
        31
      7. group Id
        FG006
        num Subjects
        13
      8. group Id
        FG007
        num Subjects
        31
      9. group Id
        FG008
        num Subjects
        33
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 217 participants were enrolled into 9 separate cohorts based on tumor histology and HER2 alteration status. All 217 participants were treated. Results reported are based on the primary completion date (PCD) of the study; data for only those secondary outcome measures are reported for which analyses were complete at PCD. Remaining outcome measures would be reported upon completion of their analyses at study completion.
recruitment Details
Participants with locally-advanced (LA) unresectable or metastatic solid tumors driven by human epidermal growth factor receptor 2 (HER2) alterations, who were previously treated, were enrolled to receive tucatinib in combination with trastuzumab in this study. Participants with hormone-receptor positive breast cancer also received fulvestrant.

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Preserved source evidence · Not medical advice