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NCT02278120 · OUTCOME

Progression Free Survival (PFS) by Investigator Assessment

Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer · Source last updated 2024-03-12

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 to first documented progression or death, assessed up to approximately 29 months

What was measured

PFS was defined as the period starting from the date of randomization to the date of the first documented progression or death caused by any reason. In cases where patients did not experience an event, the PFS was censored at the date of the last adequate tumor assessment. Clinical deterioration without objective radiological evidence was not considered as documented disease progression. PFS was assessed via local radiology assessment according to RECIST 1.1. As per protocol, the final PFS analysis was conducted after approximately 392 PFS events were documented. The Kaplan-Meier method was used to estimate PFS, and the median PFS, along with 95% confidence intervals, was reported for each treatment group. A stratified Cox regression model was used to estimate the hazard ratio of PFS, along with 95% confidence interval

Analysis population: The Full Analysis Set (FAS) including all randomized patients.

Groups in this outcome

Ribociclib + NSAI/Tamoxifen + Goserelin

Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)

Placebo + NSAI/Tamoxifen+ Goserelin

Placebo daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days).

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 + NSAI/Tamoxifen + Goserelin335
Placebo + NSAI/Tamoxifen+ Goserelin337

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ribociclib + NSAI/Tamoxifen + Goserelin23.8Not reported19.2NANA = The value was not estimable due to insufficient number of participants with events
Placebo + NSAI/Tamoxifen+ Goserelin13.0Not reported11.016.4Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.441
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.694
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0000001
    param Type
    Hazard Ratio, log
    param Value
    0.553
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.441
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.694
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0000001
    param Type
    Hazard Ratio, log
    param Value
    0.553
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        NA = The value was not estimable due to insufficient number of participants with events
        group Id
        OG000
        lower Limit
        19.2
        upper Limit
        NA
        value
        23.8
      2. group Id
        OG001
        lower Limit
        11.0
        upper Limit
        16.4
        value
        13.0
denoms
  1. counts
    1. group Id
      OG000
      value
      335
    2. group Id
      OG001
      value
      337
    units
    Participants
description
PFS was defined as the period starting from the date of randomization to the date of the first documented progression or death caused by any reason. In cases where patients did not experience an event, the PFS was censored at the date of the last adequate tumor assessment. Clinical deterioration without objective radiological evidence was not considered as documented disease progression. PFS was assessed via local radiology assessment according to RECIST 1.1. As per protocol, the final PFS analysis was conducted after approximately 392 PFS events were documented. The Kaplan-Meier method was used to estimate PFS, and the median PFS, along with 95% confidence intervals, was reported for each treatment group. A stratified Cox regression model was used to estimate the hazard ratio of PFS, along with 95% confidence interval
dispersion Type
95% Confidence Interval
groups
  1. description
    Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
    id
    OG000
    title
    Ribociclib + NSAI/Tamoxifen + Goserelin
  2. description
    Placebo daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days).
    id
    OG001
    title
    Placebo + NSAI/Tamoxifen+ Goserelin
param Type
MEDIAN
population Description
The Full Analysis Set (FAS) including all randomized patients.
reporting Status
POSTED
time Frame
From randomization to first documented progression or death, assessed up to approximately 29 months
title
Progression Free Survival (PFS) by Investigator Assessment
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice