NCT01958021 · FLOW

Participant flow

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.

groups

description
Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral
id
FG000
title
Ribociclib + Letrozole
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
FG001
title
Placebo + Letrozole

periods

drop Withdraws
reasons
group Id
FG000
num Subjects
206
group Id
FG001
num Subjects
265
type
Progressive disease
reasons
group Id
FG000
num Subjects
38
group Id
FG001
num Subjects
10
type
Adverse Event
reasons
group Id
FG000
num Subjects
29
group Id
FG001
num Subjects
25
type
Subject/guardian decision
reasons
group Id
FG000
num Subjects
28
group Id
FG001
num Subjects
21
type
Physician Decision
reasons
group Id
FG000
num Subjects
6
group Id
FG001
num Subjects
1
type
Death
reasons
group Id
FG000
num Subjects
3
group Id
FG001
num Subjects
1
type
Protocol deviation
reasons
group Id
FG000
num Subjects
24
group Id
FG001
num Subjects
11
type
Sponsor decision
milestones
achievements
group Id
FG000
num Subjects
334
group Id
FG001
num Subjects
334
type
STARTED
achievements
group Id
FG000
num Subjects
334
group Id
FG001
num Subjects
330
type
Treated
achievements
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
4
comment
Participants in the placebo arm who crossed over to the ribociclib arm and received at least one dose of ribociclib
type
Crossover Cohort
achievements
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
type
COMPLETED
achievements
group Id
FG000
num Subjects
334
group Id
FG001
num Subjects
334
type
NOT COMPLETED
title
Treatment
drop Withdraws
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
0
type
Adverse Event
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
0
type
Death
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
0
type
Lost to Follow-up
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
2
type
Physician Decision
reasons
group Id
FG000
num Subjects
12
group Id
FG001
num Subjects
3
type
Progressive disease
reasons
group Id
FG000
num Subjects
5
group Id
FG001
num Subjects
2
type
Sponsor decision
reasons
group Id
FG000
num Subjects
4
group Id
FG001
num Subjects
2
type
Subject/Guardian decision
milestones
achievements
group Id
FG000
num Subjects
26
group Id
FG001
num Subjects
9
comment
Patients who discontinue treatment for reasons other than disease progression entered the post-treatment efficacy follow-up. period.
type
STARTED
achievements
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
0
type
COMPLETED
achievements
group Id
FG000
num Subjects
25
group Id
FG001
num Subjects
9
type
NOT COMPLETED
title
Post-treatment Efficacy Follow-up

pre Assignment Details

Screening assessments were conducted up to 21 days prior to the randomization

recruitment Details

Participants were enrolled in 223 sites across 29 countries.

Complete source fields