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NCT05654623 · BASELINE

Baseline characteristics

A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer · Source last updated 2026-03-18

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

denoms
  1. counts
    1. group Id
      BG000
      value
      313
    2. group Id
      BG001
      value
      311
    3. group Id
      BG002
      value
      624
    units
    Participants
groups
  1. description
    Participants were randomized to receive vepdegestrant 200 milligrams (mg) orally, once daily on Days 1 to 28 of each 28-day cycle. Participants continued to receive assigned treatment until objective disease progression, unacceptable toxicity, death, participant refused further treatment, or one of the other reasons for treatment discontinuation per protocol was met.
    id
    BG000
    title
    Vepdegestrant (ARV-471)
  2. description
    Participants were randomized to receive fulvestrant 500 mg, intramuscularly (injection) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle starting from Cycle 2 Day 1, where 1 cycle = 28 days. Participants continued to receive assigned treatment until objective disease progression, unacceptable toxicity, death, participant refused further treatment, or one of the other reasons for treatment discontinuation per protocol was met.
    id
    BG001
    title
    Fulvestrant
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.09
          value
          60.3
        2. group Id
          BG001
          spread
          11.52
          value
          60.3
        3. group Id
          BG002
          spread
          11.8
          value
          60.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          311
        2. group Id
          BG001
          value
          310
        3. group Id
          BG002
          value
          621
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          65
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          241
        2. group Id
          BG001
          value
          240
        3. group Id
          BG002
          value
          481
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          78
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          122
        2. group Id
          BG001
          value
          129
        3. group Id
          BG002
          value
          251
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          148
        2. group Id
          BG001
          value
          143
        3. group Id
          BG002
          value
          291
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          66
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      313
    2. group Id
      BG001
      value
      311
    3. group Id
      BG002
      value
      624
    units
    Participants
groups
  1. description
    Participants were randomized to receive vepdegestrant 200 milligrams (mg) orally, once daily on Days 1 to 28 of each 28-day cycle. Participants continued to receive assigned treatment until objective disease progression, unacceptable toxicity, death, participant refused further treatment, or one of the other reasons for treatment discontinuation per protocol was met.
    id
    BG000
    title
    Vepdegestrant (ARV-471)
  2. description
    Participants were randomized to receive fulvestrant 500 mg, intramuscularly (injection) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle starting from Cycle 2 Day 1, where 1 cycle = 28 days. Participants continued to receive assigned treatment until objective disease progression, unacceptable toxicity, death, participant refused further treatment, or one of the other reasons for treatment discontinuation per protocol was met.
    id
    BG001
    title
    Fulvestrant
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.09
          value
          60.3
        2. group Id
          BG001
          spread
          11.52
          value
          60.3
        3. group Id
          BG002
          spread
          11.8
          value
          60.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          311
        2. group Id
          BG001
          value
          310
        3. group Id
          BG002
          value
          621
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          65
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          241
        2. group Id
          BG001
          value
          240
        3. group Id
          BG002
          value
          481
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          78
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          122
        2. group Id
          BG001
          value
          129
        3. group Id
          BG002
          value
          251
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          148
        2. group Id
          BG001
          value
          143
        3. group Id
          BG002
          value
          291
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          66
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice