NCT02422615 · FLOW

Participant flow

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.

groups

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
FG000
title
Ribociclib + Fulvestrant
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. Participants were unblinded after the implementation of protocol amendment 4 (29-Jan-20) and were given the option to crossover to treatment with ribociclib and fulvestrant.
id
FG001
title
Placebo + Fulvestrant

periods

drop Withdraws
reasons
group Id
FG000
num Subjects
314
group Id
FG001
num Subjects
200
type
Progressive disease
reasons
group Id
FG000
num Subjects
51
group Id
FG001
num Subjects
9
type
Adverse Event
reasons
group Id
FG000
num Subjects
32
group Id
FG001
num Subjects
8
type
Physician Decision
reasons
group Id
FG000
num Subjects
38
group Id
FG001
num Subjects
8
type
Subject/guardian decision
reasons
group Id
FG000
num Subjects
2
group Id
FG001
num Subjects
1
type
Death
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
1
type
Technical problems
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
1
type
Protocol deviation
reasons
group Id
FG000
num Subjects
46
group Id
FG001
num Subjects
14
type
Study terminated as per protocol
milestones
achievements
group Id
FG000
num Subjects
484
group Id
FG001
num Subjects
242
type
STARTED
achievements
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
1
type
Untreated
achievements
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
3
comment
Participants in the placebo+fulvestrant arm who crossed over to the ribociclib+fulvestrant arm and received at least one dose of the study treatment.
type
Crossover Cohort
achievements
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
comment
Treatment ongoing at the time of the cut-off 11-Jan-2023
type
COMPLETED
achievements
group Id
FG000
num Subjects
484
group Id
FG001
num Subjects
242
type
NOT COMPLETED
title
Treatment Period
drop Withdraws
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
0
type
Adverse Event
reasons
group Id
FG000
num Subjects
2
group Id
FG001
num Subjects
1
type
Death
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
1
type
Physician Decision
reasons
group Id
FG000
num Subjects
23
group Id
FG001
num Subjects
6
type
Progressive disease
reasons
group Id
FG000
num Subjects
2
group Id
FG001
num Subjects
0
type
Study Terminated as per protocol
reasons
group Id
FG000
num Subjects
6
group Id
FG001
num Subjects
1
type
Subject/Guardian Decision
milestones
achievements
group Id
FG000
num Subjects
34
group Id
FG001
num Subjects
9
type
STARTED
achievements
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
type
COMPLETED
achievements
group Id
FG000
num Subjects
34
group Id
FG001
num Subjects
9
type
NOT COMPLETED
title
Post-treatment Efficacy Follow-up

pre Assignment Details

Screening assessments were conducted up to 28 days prior to the randomization

recruitment Details

174 sites across 30 countries enrolled participants

Complete source fields