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NCT01942135 · BASELINE

Baseline characteristics

Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3) · Source last updated 2024-04-04

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
      347
    2. group Id
      BG001
      value
      174
    3. group Id
      BG002
      value
      521
    units
    Participants
groups
  1. description
    Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 105 cycles.
    id
    BG000
    title
    Palbociclib + Fulvestrant
  2. description
    Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 93 cycles.
    id
    BG001
    title
    Placebo + Fulvestrant
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.7
          value
          56.9
        2. group Id
          BG001
          spread
          10.4
          value
          56.8
        3. group Id
          BG002
          spread
          11.3
          value
          56.9
    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
          347
        2. group Id
          BG001
          value
          174
        3. group Id
          BG002
          value
          521
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          17
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          28
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          329
        2. group Id
          BG001
          value
          161
        3. group Id
          BG002
          value
          490
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        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
          275
        2. group Id
          BG001
          value
          138
        3. group Id
          BG002
          value
          413
        title
        Postmenopausal
      2. measurements
        1. group Id
          BG000
          value
          72
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          108
        title
        Pre/Perimenopausal
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Menopausal Status
    unit Of Measure
    Participants
population Description
The intent-to-treat (ITT) population or full analysis set included all participants who were randomized, with study intervention assignment designated according to initial randomization, regardless of whether participants received study intervention or received a different drug from that to which they were randomized.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      347
    2. group Id
      BG001
      value
      174
    3. group Id
      BG002
      value
      521
    units
    Participants
groups
  1. description
    Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 105 cycles.
    id
    BG000
    title
    Palbociclib + Fulvestrant
  2. description
    Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 93 cycles.
    id
    BG001
    title
    Placebo + Fulvestrant
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.7
          value
          56.9
        2. group Id
          BG001
          spread
          10.4
          value
          56.8
        3. group Id
          BG002
          spread
          11.3
          value
          56.9
    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
          347
        2. group Id
          BG001
          value
          174
        3. group Id
          BG002
          value
          521
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          17
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          28
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          329
        2. group Id
          BG001
          value
          161
        3. group Id
          BG002
          value
          490
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        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
          275
        2. group Id
          BG001
          value
          138
        3. group Id
          BG002
          value
          413
        title
        Postmenopausal
      2. measurements
        1. group Id
          BG000
          value
          72
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          108
        title
        Pre/Perimenopausal
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Menopausal Status
    unit Of Measure
    Participants
population Description
The intent-to-treat (ITT) population or full analysis set included all participants who were randomized, with study intervention assignment designated according to initial randomization, regardless of whether participants received study intervention or received a different drug from that to which they were randomized.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice