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NCT01958021 · OUTCOME

Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30

Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer · Source last updated 2025-03-07

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

Measure
MEAN
Unit
Score on a Scale
Interval / dispersion
Standard Deviation
Time frame
Baseline, every 2 cycles for 18 months, then every 3 cycles until last dose; at EOT (within 15 days from last dose);every 8 or 12 weeks post-treatment until progression (post-treatment efficacy visits), assessed up to 23 months. Cycle=28 days

What was measured

The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, 1 GHS/QoL scale, and 6 single items. GHS/QoL scale score ranges between 0 and 100. A high score for GHS/QoL represents better functioning or QoL.The change from baseline in the GHS/QoL score was assesed. A positive change from baseline indicated improvement. For subjects who discontinued treatment earlier and without disease progression, post-treatment efficacy follow-up visits occurred every 8 weeks after End of treatment (EOT) during the initial 18 months since start of treatment, followed by visits every 12 weeks until disease progression or end of study.

Analysis population: Randomized participants with data available at the specified time points. Number analyzed refers to the number of participants with an evaluable value at the specified time point.

Groups in this outcome

Ribociclib + Letrozole

Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral

Placebo + Letrozole

Placebo daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral. Participants were unblinded once the final OS analysis was completed and after the implementation of protocol amendment 10 (30-Apr-21) and were given the option to crossover to treatment with ribociclib + letrozole

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

Analysis denominator · Participants

GroupSource count
Ribociclib + Letrozole285
Placebo + Letrozole285

Reported measurements

Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Ribociclib + Letrozole285
Placebo + Letrozole285
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + Letrozole2.918.68Not reportedNot reportedNot reported
Placebo + Letrozole4.919.14Not reportedNot reportedNot reported
Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Ribociclib + Letrozole262
Placebo + Letrozole254
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + Letrozole4.619.86Not reportedNot reportedNot reported
Placebo + Letrozole6.819.64Not reportedNot reportedNot reported
Cycle 7 Day 1

Analysis denominator · Participants

GroupSource count
Ribociclib + Letrozole249
Placebo + Letrozole248
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + Letrozole4.620.96Not reportedNot reportedNot reported
Placebo + Letrozole6.020.19Not reportedNot reportedNot reported
Cycle 9 Day 1

Analysis denominator · Participants

GroupSource count
Ribociclib + Letrozole232
Placebo + Letrozole219
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + Letrozole5.121.95Not reportedNot reportedNot reported
Placebo + Letrozole8.020.49Not reportedNot reportedNot reported
Cycle 11 Day 1

Analysis denominator · Participants

GroupSource count
Ribociclib + Letrozole223
Placebo + Letrozole193
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + Letrozole4.921.11Not reportedNot reportedNot reported
Placebo + Letrozole7.020.45Not reportedNot reportedNot reported
Cycle 13 Day 1

Analysis denominator · Participants

GroupSource count
Ribociclib + Letrozole203
Placebo + Letrozole177
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + Letrozole5.322.37Not reportedNot reportedNot reported
Placebo + Letrozole6.520.40Not reportedNot reportedNot reported
Cycle 15 Day 1

Analysis denominator · Participants

GroupSource count
Ribociclib + Letrozole152
Placebo + Letrozole129
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + Letrozole5.521.43Not reportedNot reportedNot reported
Placebo + Letrozole8.721.23Not reportedNot reportedNot reported
Cycle 17 Day 1

Analysis denominator · Participants

GroupSource count
Ribociclib + Letrozole108
Placebo + Letrozole80
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + Letrozole4.622.85Not reportedNot reportedNot reported
Placebo + Letrozole7.421.75Not reportedNot reportedNot reported
Cycle 19 Day 1

Analysis denominator · Participants

GroupSource count
Ribociclib + Letrozole60
Placebo + Letrozole40
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + Letrozole5.023.08Not reportedNot reportedNot reported
Placebo + Letrozole7.718.81Not reportedNot reportedNot reported
Cycle 22 Day 1

Analysis denominator · Participants

GroupSource count
Ribociclib + Letrozole19
Placebo + Letrozole14
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + Letrozole4.820.09Not reportedNot reportedNot reported
Placebo + Letrozole12.514.15Not reportedNot reportedNot reported
Cycle 25 Day 1

Analysis denominator · Participants

GroupSource count
Ribociclib + Letrozole3
Placebo + Letrozole0
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + Letrozole-8.38.33Not reportedNot reportedNot reported
EOT

Analysis denominator · Participants

GroupSource count
Ribociclib + Letrozole97
Placebo + Letrozole142
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + Letrozole-1.220.97Not reportedNot reportedNot reported
Placebo + Letrozole-1.215.30Not reportedNot reportedNot reported
Post -treatment efficacy visit 1

Analysis denominator · Participants

GroupSource count
Ribociclib + Letrozole4
Placebo + Letrozole3
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + Letrozole8.328.87Not reportedNot reportedNot reported
Placebo + Letrozole-16.716.67Not reportedNot reportedNot reported
Post -treatment efficacy visit 2

Analysis denominator · Participants

GroupSource count
Ribociclib + Letrozole7
Placebo + Letrozole2
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + Letrozole3.617.25Not reportedNot reportedNot reported
Placebo + Letrozole-20.817.68Not reportedNot reportedNot reported
Post -treatment efficacy visit 3

Analysis denominator · Participants

GroupSource count
Ribociclib + Letrozole5
Placebo + Letrozole2
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + Letrozole5.021.73Not reportedNot reportedNot reported
Placebo + Letrozole-12.55.89Not reportedNot reportedNot reported
Post -treatment efficacy visit 4

Analysis denominator · Participants

GroupSource count
Ribociclib + Letrozole4
Placebo + Letrozole2
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + Letrozole6.328.36Not reportedNot reportedNot reported
Placebo + Letrozole8.30.00Not reportedNot reportedNot reported
Post -treatment efficacy visit 5

Analysis denominator · Participants

GroupSource count
Ribociclib + Letrozole3
Placebo + Letrozole2
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + Letrozole0.028.87Not reportedNot reportedNot reported
Placebo + Letrozole-4.25.89Not reportedNot reportedNot reported
Post -treatment efficacy visit 6

Analysis denominator · Participants

GroupSource count
Ribociclib + Letrozole2
Placebo + Letrozole0
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + Letrozole20.841.25Not reportedNot reportedNot reported
Post -treatment efficacy visit 7

Analysis denominator · Participants

GroupSource count
Ribociclib + Letrozole1
Placebo + Letrozole0
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + Letrozole50.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.68
        value
        2.9
      2. group Id
        OG001
        spread
        19.14
        value
        4.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        285
      2. group Id
        OG001
        value
        285
      units
      Participants
    title
    Cycle 3 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.86
        value
        4.6
      2. group Id
        OG001
        spread
        19.64
        value
        6.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        262
      2. group Id
        OG001
        value
        254
      units
      Participants
    title
    Cycle 5 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.96
        value
        4.6
      2. group Id
        OG001
        spread
        20.19
        value
        6.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        249
      2. group Id
        OG001
        value
        248
      units
      Participants
    title
    Cycle 7 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.95
        value
        5.1
      2. group Id
        OG001
        spread
        20.49
        value
        8.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        232
      2. group Id
        OG001
        value
        219
      units
      Participants
    title
    Cycle 9 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.11
        value
        4.9
      2. group Id
        OG001
        spread
        20.45
        value
        7.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        223
      2. group Id
        OG001
        value
        193
      units
      Participants
    title
    Cycle 11 Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.37
        value
        5.3
      2. group Id
        OG001
        spread
        20.40
        value
        6.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        203
      2. group Id
        OG001
        value
        177
      units
      Participants
    title
    Cycle 13 Day 1
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.43
        value
        5.5
      2. group Id
        OG001
        spread
        21.23
        value
        8.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        152
      2. group Id
        OG001
        value
        129
      units
      Participants
    title
    Cycle 15 Day 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.85
        value
        4.6
      2. group Id
        OG001
        spread
        21.75
        value
        7.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        108
      2. group Id
        OG001
        value
        80
      units
      Participants
    title
    Cycle 17 Day 1
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.08
        value
        5.0
      2. group Id
        OG001
        spread
        18.81
        value
        7.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        60
      2. group Id
        OG001
        value
        40
      units
      Participants
    title
    Cycle 19 Day 1
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.09
        value
        4.8
      2. group Id
        OG001
        spread
        14.15
        value
        12.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        14
      units
      Participants
    title
    Cycle 22 Day 1
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.33
        value
        -8.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Cycle 25 Day 1
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.97
        value
        -1.2
      2. group Id
        OG001
        spread
        15.30
        value
        -1.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        97
      2. group Id
        OG001
        value
        142
      units
      Participants
    title
    EOT
denoms
  1. counts
    1. group Id
      OG000
      value
      285
    2. group Id
      OG001
      value
      285
    units
    Participants
description
The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, 1 GHS/QoL scale, and 6 single items. GHS/QoL scale score ranges between 0 and 100. A high score for GHS/QoL represents better functioning or QoL.The change from baseline in the GHS/QoL score was assesed. A positive change from baseline indicated improvement. For subjects who discontinued treatment earlier and without disease progression, post-treatment efficacy follow-up visits occurred every 8 weeks after End of treatment (EOT) during the initial 18 months since start of treatment, followed by visits every 12 weeks until disease progression or end of study.
dispersion Type
Standard Deviation
groups
  1. description
    Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral
    id
    OG000
    title
    Ribociclib + Letrozole
  2. description
    Placebo daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral. Participants were unblinded once the final OS analysis was completed and after the implementation of protocol amendment 10 (30-Apr-21) and were given the option to crossover to treatment with ribociclib + letrozole
    id
    OG001
    title
    Placebo + Letrozole
param Type
MEAN
population Description
Randomized participants with data available at the specified time points. Number analyzed refers to the number of participants with an evaluable value at the specified time point.
reporting Status
POSTED
time Frame
Baseline, every 2 cycles for 18 months, then every 3 cycles until last dose; at EOT (within 15 days from last dose);every 8 or 12 weeks post-treatment until progression (post-treatment efficacy visits), assessed up to 23 months. Cycle=28 days
title
Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30
type
SECONDARY
unit Of Measure
Score on a Scale

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

Preserved source evidence · Not medical advice