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NCT02278120 · OUTCOME

All Collected Deaths

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
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
On-treatment: Up to 90 months. Crossover on-treatment: Up to approximately 33 months after crossing-over. Post-treatment survival follow-up: Up to 90 months. Crossover post-treatment survival follow-up: Up to approximately 33 months after crossing-over

What was measured

On-treatment deaths were collected from start of treatment to 30 days after last dose of treatment or one day before first administration of crossover treatment (for crossover participants), whichever came first. Crossover on-treatment deaths were collected from start of crossover treatment up to 30 days after last dose of crossover treatment. Post-treatment survival follow-up deaths were collected from day 31 after last dose of study treatment to end of study or one day before first administration of crossover treatment Crossover post-treatment survival follow-up deaths were collected from day 31 after last dose of crossover treatment to end of study

Analysis population: FAS including all randomized participants

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). Participants were unblinded once the final OS analysis was conducted and after the implementation of protocol amendment 6 (16-Jul-2019) and were given the option to crossover to treatment with ribociclib +NSAI/tamoxifen + goserelin

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

On-treatment deaths

Analysis denominator · Participants

GroupSource count
Ribociclib + NSAI/Tamoxifen + Goserelin335
Placebo + NSAI/Tamoxifen+ Goserelin337
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib + NSAI/Tamoxifen + Goserelin5Not reportedNot reportedNot reportedNot reported
Placebo + NSAI/Tamoxifen+ Goserelin6Not reportedNot reportedNot reportedNot reported
Crossover on-treatment deaths

Analysis denominator · Participants

GroupSource count
Ribociclib + NSAI/Tamoxifen + Goserelin0
Placebo + NSAI/Tamoxifen+ Goserelin17
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo + NSAI/Tamoxifen+ Goserelin0Not reportedNot reportedNot reportedNot reported
Post-treatment survival follow-up deaths

Analysis denominator · Participants

GroupSource count
Ribociclib + NSAI/Tamoxifen + Goserelin251
Placebo + NSAI/Tamoxifen+ Goserelin293
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib + NSAI/Tamoxifen + Goserelin168Not reportedNot reportedNot reportedNot reported
Placebo + NSAI/Tamoxifen+ Goserelin202Not reportedNot reportedNot reportedNot reported
Crossover post-treatment survival deaths

Analysis denominator · Participants

GroupSource count
Ribociclib + NSAI/Tamoxifen + Goserelin0
Placebo + NSAI/Tamoxifen+ Goserelin17
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo + NSAI/Tamoxifen+ Goserelin1Not reportedNot reportedNot reportedNot reported
All deaths

Analysis denominator · Participants

GroupSource count
Ribociclib + NSAI/Tamoxifen + Goserelin335
Placebo + NSAI/Tamoxifen+ Goserelin337
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ribociclib + NSAI/Tamoxifen + Goserelin173Not reportedNot reportedNot reportedNot reported
Placebo + NSAI/Tamoxifen+ Goserelin209Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        6
    denoms
    1. counts
      1. group Id
        OG000
        value
        335
      2. group Id
        OG001
        value
        337
      units
      Participants
    title
    On-treatment deaths
  2. categories
    1. measurements
      1. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        17
      units
      Participants
    title
    Crossover on-treatment deaths
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        168
      2. group Id
        OG001
        value
        202
    denoms
    1. counts
      1. group Id
        OG000
        value
        251
      2. group Id
        OG001
        value
        293
      units
      Participants
    title
    Post-treatment survival follow-up deaths
  4. categories
    1. measurements
      1. group Id
        OG001
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        17
      units
      Participants
    title
    Crossover post-treatment survival deaths
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        173
      2. group Id
        OG001
        value
        209
    denoms
    1. counts
      1. group Id
        OG000
        value
        335
      2. group Id
        OG001
        value
        337
      units
      Participants
    title
    All deaths
denoms
  1. counts
    1. group Id
      OG000
      value
      335
    2. group Id
      OG001
      value
      337
    units
    Participants
description
On-treatment deaths were collected from start of treatment to 30 days after last dose of treatment or one day before first administration of crossover treatment (for crossover participants), whichever came first. Crossover on-treatment deaths were collected from start of crossover treatment up to 30 days after last dose of crossover treatment. Post-treatment survival follow-up deaths were collected from day 31 after last dose of study treatment to end of study or one day before first administration of crossover treatment Crossover post-treatment survival follow-up deaths were collected from day 31 after last dose of crossover treatment to end of study
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). Participants were unblinded once the final OS analysis was conducted and after the implementation of protocol amendment 6 (16-Jul-2019) and were given the option to crossover to treatment with ribociclib +NSAI/tamoxifen + goserelin
    id
    OG001
    title
    Placebo + NSAI/Tamoxifen+ Goserelin
param Type
NUMBER
population Description
FAS including all randomized participants
reporting Status
POSTED
time Frame
On-treatment: Up to 90 months. Crossover on-treatment: Up to approximately 33 months after crossing-over. Post-treatment survival follow-up: Up to 90 months. Crossover post-treatment survival follow-up: Up to approximately 33 months after crossing-over
title
All Collected Deaths
type
POST_HOC
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice