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NCT01740427 · OUTCOME

PFS by Tumor Tissue Biomarkers Status, Including Genes (eg, Copy Numbers of CCND1, CDKN2A), Proteins (eg, Ki67, pRb), and RNA Expression (eg, cdk4, cdk6)

A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2) · Source last updated 2024-11-14

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization until end of treatment (up to approximately 24 Months)

What was measured

PFS by biomarker status by Investigator assessment. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Positive is defined as H-Score \>=1 and negative as H-Score \<1. H-Score is calculated as the sum of the % of cells at each level of staining intensity (0, 1+, 2+, and 3+) multiplied by the staining intensity value: H-Score = (% at 0)\*0 + (% at 1+)\*1 + (% at 2+)\*2 + (% at 3+)\*3. H-Score values range from 0 to 300. ER stands for estrogen receptor and Rb stands for retinoblastoma susceptibility gene product.

Analysis population: ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized. Here "Number Analyzed" signifies number of participants evaluable for specified rows.

Groups in this outcome

Palbociclib Plus Letrozole

Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.

Placebo Plus Letrozole

Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Palbociclib Plus Letrozole444
Placebo Plus Letrozole222

Reported measurements

ER Positive

Analysis denominator · Participants

GroupSource count
Palbociclib Plus Letrozole338
Placebo Plus Letrozole166
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole24.9Not reported22.2NANot reached; insufficient number of participants with events.
Placebo Plus Letrozole16.3Not reported12.919.1Not reported
ER Negative

Analysis denominator · Participants

GroupSource count
Palbociclib Plus Letrozole40
Placebo Plus Letrozole22
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole15.6Not reported8.322.0Not reported
Placebo Plus Letrozole5.4Not reported2.711.1Not reported
Rb Positive

Analysis denominator · Participants

GroupSource count
Palbociclib Plus Letrozole345
Placebo Plus Letrozole167
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole24.2Not reported21.425.7Not reported
Placebo Plus Letrozole13.7Not reported11.016.5Not reported
Rb Negative

Analysis denominator · Participants

GroupSource count
Palbociclib Plus Letrozole29
Placebo Plus Letrozole22
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus LetrozoleNANot reported11.4NANot reached; insufficient number of participants with events.
Placebo Plus Letrozole18.5Not reported2.9NANot reached; insufficient number of participants with events.
Cyclin D1 Positive

Analysis denominator · Participants

GroupSource count
Palbociclib Plus Letrozole370
Placebo Plus Letrozole179
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole24.8Not reported21.527.6Not reported
Placebo Plus Letrozole13.8Not reported11.316.8Not reported
Cyclin D1 Negative

Analysis denominator · Participants

GroupSource count
Palbociclib Plus Letrozole5
Placebo Plus Letrozole10
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole11.1Not reported2.223.9Not reported
Placebo Plus Letrozole8.1Not reported0.4NANot reached; insufficient number of participants with events.
p16 Positive

Analysis denominator · Participants

GroupSource count
Palbociclib Plus Letrozole305
Placebo Plus Letrozole161
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole24.8Not reported21.5NANot reached; insufficient number of participants with events.
Placebo Plus Letrozole13.8Not reported11.116.8Not reported
p16 Negative

Analysis denominator · Participants

GroupSource count
Palbociclib Plus Letrozole59
Placebo Plus Letrozole25
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole16.8Not reported11.124.9Not reported
Placebo Plus Letrozole13.8Not reported8.1NANot reached; insufficient number of participants with events.
p16 H-Score<175

Analysis denominator · Participants

GroupSource count
Palbociclib Plus Letrozole341
Placebo Plus Letrozole177
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole23.7Not reported19.625.7Not reported
Placebo Plus Letrozole13.8Not reported11.216.8Not reported
p16 H-Score>=175

Analysis denominator · Participants

GroupSource count
Palbociclib Plus Letrozole23
Placebo Plus Letrozole9
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole24.2Not reported11.1NANot reached; insufficient number of participants with events.
Placebo Plus Letrozole5.6Not reported1.519.1Not reported
Ki67 <=20%

Analysis denominator · Participants

GroupSource count
Palbociclib Plus Letrozole216
Placebo Plus Letrozole102
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole27.6Not reported24.2NANot reached; insufficient number of participants with events.
Placebo Plus Letrozole16.8Not reported13.722.0Not reported
Ki67 >20%

Analysis denominator · Participants

GroupSource count
Palbociclib Plus Letrozole152
Placebo Plus Letrozole83
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib Plus Letrozole17.5Not reported13.822.0Not reported
Placebo Plus Letrozole8.4Not reported5.613.6Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.443
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.737
    estimate Comment
    Unstratified Cox proportional hazards model was used.
    group Description
    Statistical analysis for ER positive
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.571
    statistical Method
    Unstratified log-rank test
  2. ci Lower Limit
    0.218
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.751
    estimate Comment
    Unstratified Cox proportional hazards model was used.
    group Description
    Statistical analysis for ER Negative
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0030
    param Type
    Hazard Ratio (HR)
    param Value
    0.405
    statistical Method
    Unstratified log-rank test
  3. ci Lower Limit
    0.416
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.680
    estimate Comment
    Unstratified Cox proportional hazards model was used.
    group Description
    Statistical analysis for Rb Positive
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.531
    statistical Method
    Unstratified log-rank test
  4. ci Lower Limit
    0.308
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.481
    estimate Comment
    Unstratified Cox proportional hazards model was used.
    group Description
    Statistical analysis for Rb Negative
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.3237
    param Type
    Hazard Ratio (HR)
    param Value
    0.675
    statistical Method
    Unstratified log-rank test
  5. ci Lower Limit
    0.437
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.705
    estimate Comment
    Unstratified Cox proportional hazards model was used.
    group Description
    Statistical analysis for Cyclin D1 Positive
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.555
    statistical Method
    Unstratified log-rank test
  6. ci Lower Limit
    0.287
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.461
    estimate Comment
    Unstratified Cox proportional hazards model was used.
    group Description
    Statistical analysis for Cyclin D1 Negative
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.9964
    param Type
    Hazard Ratio (HR)
    param Value
    0.997
    statistical Method
    Unstratified log-rank test
  7. ci Lower Limit
    0.400
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.670
    estimate Comment
    Unstratified Cox proportional hazards model was used.
    group Description
    Statistical analysis for p16 Positive
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.518
    statistical Method
    Unstratified log-rank test
  8. ci Lower Limit
    0.392
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.364
    estimate Comment
    Unstratified Cox proportional hazards model was used.
    group Description
    Statistical analysis for p16 Negative
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.3221
    param Type
    Hazard Ratio (HR)
    param Value
    0.731
    statistical Method
    Unstratified log-rank test
  9. ci Lower Limit
    0.455
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.742
    estimate Comment
    Unstratified Cox proportional hazards model was used.
    group Description
    Statistical analysis for p16 HScore\<175
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.581
    statistical Method
    Unstratified log-rank test
  10. ci Lower Limit
    0.100
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.650
    estimate Comment
    Unstratified Cox proportional hazards model was used.
    group Description
    Statistical analysis for p16 HScore\>=175
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0022
    param Type
    Hazard Ratio (HR)
    param Value
    0.255
    statistical Method
    Unstratified log-rank test
  11. ci Lower Limit
    0.379
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.742
    estimate Comment
    Unstratified Cox proportional hazards model was used.
    group Description
    Statistical analysis for Ki67 \<=20%
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0002
    param Type
    Hazard Ratio (HR)
    param Value
    0.530
    statistical Method
    Unstratified log-rank test
  12. ci Lower Limit
    0.409
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.791
    estimate Comment
    Unstratified Cox proportional hazards model was used.
    group Description
    Statistical analysis for Ki67 \>20%
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0007
    param Type
    Hazard Ratio (HR)
    param Value
    0.569
    statistical Method
    Unstratified log-rank test
Complete source fields
analyses
  1. ci Lower Limit
    0.443
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.737
    estimate Comment
    Unstratified Cox proportional hazards model was used.
    group Description
    Statistical analysis for ER positive
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.571
    statistical Method
    Unstratified log-rank test
  2. ci Lower Limit
    0.218
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.751
    estimate Comment
    Unstratified Cox proportional hazards model was used.
    group Description
    Statistical analysis for ER Negative
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0030
    param Type
    Hazard Ratio (HR)
    param Value
    0.405
    statistical Method
    Unstratified log-rank test
  3. ci Lower Limit
    0.416
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.680
    estimate Comment
    Unstratified Cox proportional hazards model was used.
    group Description
    Statistical analysis for Rb Positive
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.531
    statistical Method
    Unstratified log-rank test
  4. ci Lower Limit
    0.308
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.481
    estimate Comment
    Unstratified Cox proportional hazards model was used.
    group Description
    Statistical analysis for Rb Negative
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.3237
    param Type
    Hazard Ratio (HR)
    param Value
    0.675
    statistical Method
    Unstratified log-rank test
  5. ci Lower Limit
    0.437
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.705
    estimate Comment
    Unstratified Cox proportional hazards model was used.
    group Description
    Statistical analysis for Cyclin D1 Positive
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.555
    statistical Method
    Unstratified log-rank test
  6. ci Lower Limit
    0.287
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.461
    estimate Comment
    Unstratified Cox proportional hazards model was used.
    group Description
    Statistical analysis for Cyclin D1 Negative
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.9964
    param Type
    Hazard Ratio (HR)
    param Value
    0.997
    statistical Method
    Unstratified log-rank test
  7. ci Lower Limit
    0.400
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.670
    estimate Comment
    Unstratified Cox proportional hazards model was used.
    group Description
    Statistical analysis for p16 Positive
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.518
    statistical Method
    Unstratified log-rank test
  8. ci Lower Limit
    0.392
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.364
    estimate Comment
    Unstratified Cox proportional hazards model was used.
    group Description
    Statistical analysis for p16 Negative
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.3221
    param Type
    Hazard Ratio (HR)
    param Value
    0.731
    statistical Method
    Unstratified log-rank test
  9. ci Lower Limit
    0.455
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.742
    estimate Comment
    Unstratified Cox proportional hazards model was used.
    group Description
    Statistical analysis for p16 HScore\<175
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.581
    statistical Method
    Unstratified log-rank test
  10. ci Lower Limit
    0.100
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.650
    estimate Comment
    Unstratified Cox proportional hazards model was used.
    group Description
    Statistical analysis for p16 HScore\>=175
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0022
    param Type
    Hazard Ratio (HR)
    param Value
    0.255
    statistical Method
    Unstratified log-rank test
  11. ci Lower Limit
    0.379
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.742
    estimate Comment
    Unstratified Cox proportional hazards model was used.
    group Description
    Statistical analysis for Ki67 \<=20%
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0002
    param Type
    Hazard Ratio (HR)
    param Value
    0.530
    statistical Method
    Unstratified log-rank test
  12. ci Lower Limit
    0.409
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.791
    estimate Comment
    Unstratified Cox proportional hazards model was used.
    group Description
    Statistical analysis for Ki67 \>20%
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0007
    param Type
    Hazard Ratio (HR)
    param Value
    0.569
    statistical Method
    Unstratified log-rank test
classes
  1. categories
    1. measurements
      1. comment
        Not reached; insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        22.2
        upper Limit
        NA
        value
        24.9
      2. group Id
        OG001
        lower Limit
        12.9
        upper Limit
        19.1
        value
        16.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        338
      2. group Id
        OG001
        value
        166
      units
      Participants
    title
    ER Positive
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.3
        upper Limit
        22.0
        value
        15.6
      2. group Id
        OG001
        lower Limit
        2.7
        upper Limit
        11.1
        value
        5.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        40
      2. group Id
        OG001
        value
        22
      units
      Participants
    title
    ER Negative
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        21.4
        upper Limit
        25.7
        value
        24.2
      2. group Id
        OG001
        lower Limit
        11.0
        upper Limit
        16.5
        value
        13.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        345
      2. group Id
        OG001
        value
        167
      units
      Participants
    title
    Rb Positive
  4. categories
    1. measurements
      1. comment
        Not reached; insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        11.4
        upper Limit
        NA
        value
        NA
      2. comment
        Not reached; insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        2.9
        upper Limit
        NA
        value
        18.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        22
      units
      Participants
    title
    Rb Negative
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        21.5
        upper Limit
        27.6
        value
        24.8
      2. group Id
        OG001
        lower Limit
        11.3
        upper Limit
        16.8
        value
        13.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        370
      2. group Id
        OG001
        value
        179
      units
      Participants
    title
    Cyclin D1 Positive
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.2
        upper Limit
        23.9
        value
        11.1
      2. comment
        Not reached; insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        0.4
        upper Limit
        NA
        value
        8.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        10
      units
      Participants
    title
    Cyclin D1 Negative
  7. categories
    1. measurements
      1. comment
        Not reached; insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        21.5
        upper Limit
        NA
        value
        24.8
      2. group Id
        OG001
        lower Limit
        11.1
        upper Limit
        16.8
        value
        13.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        305
      2. group Id
        OG001
        value
        161
      units
      Participants
    title
    p16 Positive
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.1
        upper Limit
        24.9
        value
        16.8
      2. comment
        Not reached; insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        8.1
        upper Limit
        NA
        value
        13.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      2. group Id
        OG001
        value
        25
      units
      Participants
    title
    p16 Negative
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        19.6
        upper Limit
        25.7
        value
        23.7
      2. group Id
        OG001
        lower Limit
        11.2
        upper Limit
        16.8
        value
        13.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        341
      2. group Id
        OG001
        value
        177
      units
      Participants
    title
    p16 H-Score<175
  10. categories
    1. measurements
      1. comment
        Not reached; insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        11.1
        upper Limit
        NA
        value
        24.2
      2. group Id
        OG001
        lower Limit
        1.5
        upper Limit
        19.1
        value
        5.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        9
      units
      Participants
    title
    p16 H-Score>=175
  11. categories
    1. measurements
      1. comment
        Not reached; insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        24.2
        upper Limit
        NA
        value
        27.6
      2. group Id
        OG001
        lower Limit
        13.7
        upper Limit
        22.0
        value
        16.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        216
      2. group Id
        OG001
        value
        102
      units
      Participants
    title
    Ki67 <=20%
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        13.8
        upper Limit
        22.0
        value
        17.5
      2. group Id
        OG001
        lower Limit
        5.6
        upper Limit
        13.6
        value
        8.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        152
      2. group Id
        OG001
        value
        83
      units
      Participants
    title
    Ki67 >20%
denoms
  1. counts
    1. group Id
      OG000
      value
      444
    2. group Id
      OG001
      value
      222
    units
    Participants
description
PFS by biomarker status by Investigator assessment. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Positive is defined as H-Score \>=1 and negative as H-Score \<1. H-Score is calculated as the sum of the % of cells at each level of staining intensity (0, 1+, 2+, and 3+) multiplied by the staining intensity value: H-Score = (% at 0)\*0 + (% at 1+)\*1 + (% at 2+)\*2 + (% at 3+)\*3. H-Score values range from 0 to 300. ER stands for estrogen receptor and Rb stands for retinoblastoma susceptibility gene product.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
    id
    OG000
    title
    Palbociclib Plus Letrozole
  2. description
    Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
    id
    OG001
    title
    Placebo Plus Letrozole
param Type
MEDIAN
population Description
ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized. Here "Number Analyzed" signifies number of participants evaluable for specified rows.
reporting Status
POSTED
time Frame
From randomization until end of treatment (up to approximately 24 Months)
title
PFS by Tumor Tissue Biomarkers Status, Including Genes (eg, Copy Numbers of CCND1, CDKN2A), Proteins (eg, Ki67, pRb), and RNA Expression (eg, cdk4, cdk6)
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice