Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer

Draft scope assessment: unclear. Attached because the study's own record names HR. The study record does not state positive, so it may describe a different alteration of the same gene. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.

All randomized participants (including censored). Censored participants: Abemaciclib plus fulvestrant (n = 65), Placebo plus fulvestrant (n = 45).

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secondary · POSTED

PFS is defined as the time from the date of randomization to the earliest date of disease progression determined by blinded independent central review (BICR) or death from any cause, whichever occurs first.

All randomized participants.

→

secondary · POSTED

ORR is the best overall tumor response of CR or PR as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.

All randomized participants.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-breast-cancer-femara-ea5f0363
nct id: NCT05169567
trial label: Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer
applicability: unclear
applicability note: Attached because the study's own record names HR. The study record does not state positive, so it may describe a different alteration of the same gene. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 3
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT05169567
outcome key
om-0000
source section id
NCT05169567-om-0000
source outcome index
0
endpoint
Progression-Free Survival (PFS)
endpoint definition
PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
time origin
Randomization to the date of first documented progression of disease or death from any cause (Up to 21 Months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All randomized participants (including censored). Censored participants: Abemaciclib plus fulvestrant (n = 65), Placebo plus fulvestrant (n = 45).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT05169567
outcome key
om-0001
source section id
NCT05169567-om-0001
source outcome index
1
endpoint
Progression Free Survival (PFS) Determined by Blinded Independent Central Review (BICR)
endpoint definition
PFS is defined as the time from the date of randomization to the earliest date of disease progression determined by blinded independent central review (BICR) or death from any cause, whichever occurs first.
time origin
Randomization to the date of first documented progression of disease or death from any cause (Up to 22 Months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All randomized participants.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT05169567
outcome key
om-0002
source section id
NCT05169567-om-0002
source outcome index
2
endpoint
Objective Response Rate (ORR): Percentage of Participants Who Achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR)
endpoint definition
ORR is the best overall tumor response of CR or PR as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
time origin
Randomization until measured progressive disease (Up to 22 Months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All randomized participants.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT05169567
outcome key
om-0000
arm key
OG000
arm label
Arm A: Abemaciclib Plus Fulvestrant
regimen
Abemaciclib 150 mg administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
analyzed count
182
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05169567-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT05169567
outcome key
om-0000
arm key
OG001
arm label
Arm B: Placebo Plus Fulvestrant
regimen
Placebo administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
analyzed count
186
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05169567-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT05169567
outcome key
om-0001
arm key
OG000
arm label
Arm A: Abemaciclib Plus Fulvestrant
regimen
Abemaciclib 150 mg administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
analyzed count
182
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05169567-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT05169567
outcome key
om-0001
arm key
OG001
arm label
Arm B: Placebo Plus Fulvestrant
regimen
Placebo administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
analyzed count
186
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05169567-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT05169567
outcome key
om-0002
arm key
OG000
arm label
Arm A: Abemaciclib Plus Fulvestrant
regimen
Abemaciclib 150 mg administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
analyzed count
182
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05169567-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT05169567
outcome key
om-0002
arm key
OG001
arm label
Arm B: Placebo Plus Fulvestrant
regimen
Placebo administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
analyzed count
186
analyzed unit
Participants
is comparator
Source null
source pointer
NCT05169567-om-0002#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT05169567
harm key
EG000
source section id
NCT05169567-ae
event group key
EG000
event group label
Arm A: Abemaciclib Plus Fulvestrant
serious affected
44
serious at risk
181
other affected
173
other at risk
181
frequency threshold
5
collection period
Baseline up to 22 months
event definition
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT05169567
harm key
EG001
source section id
NCT05169567-ae
event group key
EG001
event group label
Arm B: Placebo Plus Fulvestrant
serious affected
20
serious at risk
185
other affected
131
other at risk
185
frequency threshold
5
collection period
Baseline up to 22 months
event definition
All participants who received at least one dose of the study drug, regardless of their eligibility for the study.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice