Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02422615 · OUTCOME

Duration of Response (DOR) Per Investigator Assessment

Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer. · Source last updated 2023-11-30

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 first documented response to progression or death, assessed up to approximately 26 months

What was measured

DOR was defined as the time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer as defined in RECIST 1.1 per investigator assessment. The Kaplan-Meier method was used to estimate DOR, and the median DOR, along with 95% confidence intervals, was reported for each treatment group. If a participant had not had an event, duration was censored at the date of last adequate tumor assessment. CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Analysis population: Randomized participants with confirmed CR or PR as per investigator assessment

Groups in this outcome

Ribociclib + Fulvestrant

Ribociclib was administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1.

Placebo + Fulvestrant

Placebo was administered orally for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1.

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 + Fulvestrant157
Placebo + Fulvestrant52

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ribociclib + FulvestrantNANot reported16.1NANA: Not estimable due to the insufficient number of participants with events
Placebo + FulvestrantNANot reported13.8NANA: Not estimable due to the insufficient number of participants with events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA: Not estimable due to the insufficient number of participants with events
        group Id
        OG000
        lower Limit
        16.1
        upper Limit
        NA
        value
        NA
      2. comment
        NA: Not estimable due to the insufficient number of participants with events
        group Id
        OG001
        lower Limit
        13.8
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      157
    2. group Id
      OG001
      value
      52
    units
    Participants
description
DOR was defined as the time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer as defined in RECIST 1.1 per investigator assessment. The Kaplan-Meier method was used to estimate DOR, and the median DOR, along with 95% confidence intervals, was reported for each treatment group. If a participant had not had an event, duration was censored at the date of last adequate tumor assessment. CR: Disappearance of all lesions with lymph nodes measuring \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
dispersion Type
95% Confidence Interval
groups
  1. description
    Ribociclib was administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1.
    id
    OG000
    title
    Ribociclib + Fulvestrant
  2. description
    Placebo was administered orally for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1.
    id
    OG001
    title
    Placebo + Fulvestrant
param Type
MEDIAN
population Description
Randomized participants with confirmed CR or PR as per investigator assessment
reporting Status
POSTED
time Frame
From first documented response to progression or death, assessed up to approximately 26 months
title
Duration of Response (DOR) Per Investigator Assessment
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice