PALbociclib CoLlaborative Adjuvant Study

Draft scope assessment: unclear. Attached because the study's own record names HR. 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

Invasive disease-free survival (iDFS) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC) at 4 years. iDFS is defined as the time from randomization to the date of the first event: local/regional invasive ipsilateral recurrence, contralateral invasive breast cancer, distant recurrence, second primary invasive cancer of non-breast origin or death from any cause. Direct comparison between arms used time to iDFS events and Kaplan-Meier Log-rank analysis. Due to the medians not yet achieved, the percentage of patients considered iDFS at 4 years is reported.

Source null

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secondary · POSTED

Invasive disease-free survival (iDFS, excluding second primary invasive cancers of non-breast origin) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC) at 4 years. iDFS excluding second primary invasive cancers of non-breast origin is defined as the time from randomization to the date of the first event: local/regional invasive ipsilateral recurrence, contralateral invasive breast cancer, distant recurrence, or death from any cause. Second primary invasive cancers of non-breast origin will not be considered as events for this endpoint. Direct comparison between arms used time to iDFS events and Kaplan-Meier Log-rank analysis. Due to the medians not yet achieved, the percentage of patients considered iDFS at 4 years is reported.

Source null

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secondary · POSTED

Compare time to distant recurrence-free survival (DRFS). Distant recurrence is defined according to STEEP criteria as the time from randomization to the date of the first event: distant recurrence or death from any cause. Patients with a locoregional recurrence will continue to be followed for DRFS. Surviving patients who are event-free will be censored at: the date of last disease assessment, or withdrawal of consent to be followed, or death whichever came first. Direct comparison between arms used time to DRFS events and Kaplan-Meier Log-rank analysis. Due to the medians not yet achieved, the percentage of patients considered DRFS at 4 years is reported.

Source null

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secondary · POSTED

Compare overall survival (OS). Overall survival is defined as the time period between randomization and death. Surviving patients classified as lost-to-follow up or having withdrawn consent to be followed will be censored at their date of last contact or withdrawal of consent to be followed, whichever occurs first.

Source null

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secondary · POSTED

Compare locoregional recurrence-free survival (LRRFS). LRRFS is defined as the time from randomization to the date of the first event: local/regional invasive ipsilateral recurrence, contralateral invasive breast cancer, or death from any cause. Patients with second primary invasive cancers of non-breast origin or distant recurrence will be censored at the date of diagnosis. Surviving patients who are event-free will be censored at: the date of last disease assessment, or withdrawal of consent to be followed, whichever occurs first.

Source null

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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: NCT02513394
trial label: PALbociclib CoLlaborative Adjuvant Study
applicability: unclear
applicability note: Attached because the study's own record names HR. 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: 5
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT02513394
outcome key
om-0000
source section id
NCT02513394-om-0000
source outcome index
0
endpoint
Invasive Disease Free Survival (iDFS)
endpoint definition
Invasive disease-free survival (iDFS) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC) at 4 years. iDFS is defined as the time from randomization to the date of the first event: local/regional invasive ipsilateral recurrence, contralateral invasive breast cancer, distant recurrence, second primary invasive cancer of non-breast origin or death from any cause. Direct comparison between arms used time to iDFS events and Kaplan-Meier Log-rank analysis. Due to the medians not yet achieved, the percentage of patients considered iDFS at 4 years is reported.
time origin
4 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population 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
NCT02513394
outcome key
om-0001
source section id
NCT02513394-om-0001
source outcome index
1
endpoint
Invasive Disease Free Survival (iDFS) Excluding Second Primary Invasive Cancers of Non-breast Origin.
endpoint definition
Invasive disease-free survival (iDFS, excluding second primary invasive cancers of non-breast origin) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC) at 4 years. iDFS excluding second primary invasive cancers of non-breast origin is defined as the time from randomization to the date of the first event: local/regional invasive ipsilateral recurrence, contralateral invasive breast cancer, distant recurrence, or death from any cause. Second primary invasive cancers of non-breast origin will not be considered as events for this endpoint. Direct comparison between arms used time to iDFS events and Kaplan-Meier Log-rank analysis. Due to the medians not yet achieved, the percentage of patients considered iDFS at 4 years is reported.
time origin
4 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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
NCT02513394
outcome key
om-0002
source section id
NCT02513394-om-0002
source outcome index
2
endpoint
Distant Recurrence-free Survival (DRFS)
endpoint definition
Compare time to distant recurrence-free survival (DRFS). Distant recurrence is defined according to STEEP criteria as the time from randomization to the date of the first event: distant recurrence or death from any cause. Patients with a locoregional recurrence will continue to be followed for DRFS. Surviving patients who are event-free will be censored at: the date of last disease assessment, or withdrawal of consent to be followed, or death whichever came first. Direct comparison between arms used time to DRFS events and Kaplan-Meier Log-rank analysis. Due to the medians not yet achieved, the percentage of patients considered DRFS at 4 years is reported.
time origin
4 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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
NCT02513394
outcome key
om-0003
source section id
NCT02513394-om-0003
source outcome index
3
endpoint
Overall Survival (OS)
endpoint definition
Compare overall survival (OS). Overall survival is defined as the time period between randomization and death. Surviving patients classified as lost-to-follow up or having withdrawn consent to be followed will be censored at their date of last contact or withdrawal of consent to be followed, whichever occurs first.
time origin
4 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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
NCT02513394
outcome key
om-0004
source section id
NCT02513394-om-0004
source outcome index
4
endpoint
Locoregional Recurrences-free Survival (LRRFS)
endpoint definition
Compare locoregional recurrence-free survival (LRRFS). LRRFS is defined as the time from randomization to the date of the first event: local/regional invasive ipsilateral recurrence, contralateral invasive breast cancer, or death from any cause. Patients with second primary invasive cancers of non-breast origin or distant recurrence will be censored at the date of diagnosis. Surviving patients who are event-free will be censored at: the date of last disease assessment, or withdrawal of consent to be followed, whichever occurs first.
time origin
4 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
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
NCT02513394
outcome key
om-0000
arm key
OG000
arm label
Palbociclib Plus Endocrine Therapy (Arm A)
regimen
Palbociclib at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years.
analyzed count
2884
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02513394-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT02513394
outcome key
om-0000
arm key
OG001
arm label
Endocrine Therapy Alone (Arm B)
regimen
Standard adjuvant endocrine therapy for a duration of at least 5 years.
analyzed count
2877
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02513394-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT02513394
outcome key
om-0001
arm key
OG000
arm label
Palbociclib Plus Endocrine Therapy (Arm A)
regimen
Palbociclib at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years.
analyzed count
2884
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02513394-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT02513394
outcome key
om-0001
arm key
OG001
arm label
Endocrine Therapy Alone (Arm B)
regimen
Standard adjuvant endocrine therapy for a duration of at least 5 years.
analyzed count
2877
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02513394-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT02513394
outcome key
om-0002
arm key
OG000
arm label
Palbociclib Plus Endocrine Therapy (Arm A)
regimen
Palbociclib at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years.
analyzed count
2884
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02513394-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT02513394
outcome key
om-0002
arm key
OG001
arm label
Endocrine Therapy Alone (Arm B)
regimen
Standard adjuvant endocrine therapy for a duration of at least 5 years.
analyzed count
2877
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02513394-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT02513394
outcome key
om-0003
arm key
OG000
arm label
Palbociclib Plus Endocrine Therapy (Arm A)
regimen
Palbociclib at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years.
analyzed count
2884
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02513394-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT02513394
outcome key
om-0003
arm key
OG001
arm label
Endocrine Therapy Alone (Arm B)
regimen
Standard adjuvant endocrine therapy for a duration of at least 5 years.
analyzed count
2877
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02513394-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT02513394
outcome key
om-0004
arm key
OG000
arm label
Palbociclib Plus Endocrine Therapy (Arm A)
regimen
Palbociclib at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years.
analyzed count
2884
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02513394-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT02513394
outcome key
om-0004
arm key
OG001
arm label
Endocrine Therapy Alone (Arm B)
regimen
Standard adjuvant endocrine therapy for a duration of at least 5 years.
analyzed count
2877
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02513394-om-0004#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT02513394
harm key
EG000
source section id
NCT02513394-ae
event group key
EG000
event group label
Palbociclib Plus Endocrine Therapy (Arm A)
serious affected
369
serious at risk
2841
other affected
2824
other at risk
2841
frequency threshold
0
collection period
4 years
event definition
The safety analysis is conducted in the "as-treated" population. Patients randomly assigned to the Arm A who never received Palbociclib but received endocrine therapy (N=36) were included in Arm B for the safety analyses. Thus, the safety analysis included 2841 patients who received at least one dose of Palbociclib plus endocrine therapy and 2902 patients who received endocrine therapy (which included 36 patients from Arm A who received endocrine therapy only).
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
NCT02513394
harm key
EG001
source section id
NCT02513394-ae
event group key
EG001
event group label
Endocrine Therapy Alone (Arm B)
serious affected
229
serious at risk
2902
other affected
2600
other at risk
2902
frequency threshold
0
collection period
4 years
event definition
The safety analysis is conducted in the "as-treated" population. Patients randomly assigned to the Arm A who never received Palbociclib but received endocrine therapy (N=36) were included in Arm B for the safety analyses. Thus, the safety analysis included 2841 patients who received at least one dose of Palbociclib plus endocrine therapy and 2902 patients who received endocrine therapy (which included 36 patients from Arm A who received endocrine therapy only).
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