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NCT03901339 · FLOW

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Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer · Source last updated 2024-10-21

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

groups
  1. description
    Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, occurrence of unacceptable adverse events (AEs), or another treatment discontinuation criterion was met (up to 40.1 months).
    id
    FG000
    title
    Sacituzumab Govitecan
  2. description
    Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent treatment that was determined by the investigator before participant randomization until progression of disease, occurrence of unacceptable adverse events (AEs), or another treatment discontinuation criterion was met. Dosing per National Comprehensive Cancer Network (NCCN) guidelines (with dose modifications for if toxic) * Eribulin was administered IV at a dose 1.4 mg/m\^2 at North American sites and 1.2 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle (up to 22.5 months). * Capecitabine 1000 to 1250 mg/m\^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period (up to 12.9 months). * Gemcitabine 800 to 1200 mg/m\^2 was administered IV on Days 1, 8, and 15 of a 28-day cycle (up to 22.3 months). * Vinorelbine 25 mg/m\^2 was administered as a weekly IV injection (up to 8.1 months). Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
    id
    FG001
    title
    Treatment of Physician's Choice (TPC)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        220
      2. group Id
        FG001
        num Subjects
        192
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        40
      type
      Informed consent withdrawn
    3. reasons
      1. group Id
        FG000
        num Subjects
        30
      2. group Id
        FG001
        num Subjects
        23
      type
      Sponsor request
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        7
      type
      Reason not specified
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        7
      type
      Lost to Follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Covid19
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        272
      2. group Id
        FG001
        num Subjects
        271
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        268
      2. group Id
        FG001
        num Subjects
        249
      type
      Received at Least 1 Dose of Study Drug
    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
        272
      2. group Id
        FG001
        num Subjects
        271
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
776 participants were screened.
recruitment Details
Participants were enrolled at study sites in Belgium, Canada, France, Germany, Italy, the Netherlands, Spain, the United Kingdom, and the United States.
Complete source fields
groups
  1. description
    Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, occurrence of unacceptable adverse events (AEs), or another treatment discontinuation criterion was met (up to 40.1 months).
    id
    FG000
    title
    Sacituzumab Govitecan
  2. description
    Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent treatment that was determined by the investigator before participant randomization until progression of disease, occurrence of unacceptable adverse events (AEs), or another treatment discontinuation criterion was met. Dosing per National Comprehensive Cancer Network (NCCN) guidelines (with dose modifications for if toxic) * Eribulin was administered IV at a dose 1.4 mg/m\^2 at North American sites and 1.2 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle (up to 22.5 months). * Capecitabine 1000 to 1250 mg/m\^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period (up to 12.9 months). * Gemcitabine 800 to 1200 mg/m\^2 was administered IV on Days 1, 8, and 15 of a 28-day cycle (up to 22.3 months). * Vinorelbine 25 mg/m\^2 was administered as a weekly IV injection (up to 8.1 months). Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
    id
    FG001
    title
    Treatment of Physician's Choice (TPC)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        220
      2. group Id
        FG001
        num Subjects
        192
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        13
      2. group Id
        FG001
        num Subjects
        40
      type
      Informed consent withdrawn
    3. reasons
      1. group Id
        FG000
        num Subjects
        30
      2. group Id
        FG001
        num Subjects
        23
      type
      Sponsor request
    4. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        7
      type
      Reason not specified
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        7
      type
      Lost to Follow-up
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      type
      Covid19
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        272
      2. group Id
        FG001
        num Subjects
        271
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        268
      2. group Id
        FG001
        num Subjects
        249
      type
      Received at Least 1 Dose of Study Drug
    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
        272
      2. group Id
        FG001
        num Subjects
        271
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
776 participants were screened.
recruitment Details
Participants were enrolled at study sites in Belgium, Canada, France, Germany, Italy, the Netherlands, Spain, the United Kingdom, and the United States.

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Preserved source evidence · Not medical advice