Skip to content
Triangle logo TriangleGet started
← Femara: Breast cancer with HR positive

NCT02947685 · STUDY IN CONTEXT

Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer

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

The time from registration to disease progression or death.

Source null

→

secondary · POSTED

Defined as time from date of randomization to date of death due to any cause

Source null

→

secondary · POSTED

Defined as the percentage of patients still alive and followed at 3 and 5 years post beginning of treatment.

Source null

→

secondary · POSTED

Defined as proportion of patients that achieve complete response (CR) or partial response (PR) according to RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Patients evaluated for disease

→

secondary · POSTED

Defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death from any cause, whichever occurs first

Patients that achieved confirmed response

→

secondary · POSTED

The Clinical Benefit Rate (CBR) on each treatment arm will be estimated by dividing the number of patients with CR, PR, or SD/Non-CR and Non-PD (for patients with measurable disease) for ≥ 24 weeks by the number of patients randomized to the treatment arm.

Source null

→

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

FACT · Patient Reported Outcomes

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT02947685
qol key
qol-0007
source section id
NCT02947685-om-0007
source outcome index
7
instrument
FACT
instrument basis
matched 'fact-b' in the study's own wording
scale title
Patient Reported Outcomes
measure definition
Time to symptom progression (FACT-B PFB-TOI), breast cancer specific health treatment related quality of life and general health status
time frame
24 months
analysis role
secondary
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-femara-ea5f0363
nct id
NCT02947685
trial label
Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer
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
6
harms Count
2
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-femara-ea5f0363
    nct id
    NCT02947685
    outcome key
    om-0000
    source section id
    NCT02947685-om-0000
    source outcome index
    0
    endpoint
    Progression-free Survival (PFS) as Assessed by Investigator
    endpoint definition
    The time from registration to disease progression or death.
    time origin
    7 years 3 months
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-femara-ea5f0363
    nct id
    NCT02947685
    outcome key
    om-0001
    source section id
    NCT02947685-om-0001
    source outcome index
    1
    endpoint
    Overall Survival (OS)
    endpoint definition
    Defined as time from date of randomization to date of death due to any cause
    time origin
    7 years 3 months
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-femara-ea5f0363
    nct id
    NCT02947685
    outcome key
    om-0002
    source section id
    NCT02947685-om-0002
    source outcome index
    2
    endpoint
    3 and 5 Year Survival Probabilities
    endpoint definition
    Defined as the percentage of patients still alive and followed at 3 and 5 years post beginning of treatment.
    time origin
    5 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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-femara-ea5f0363
    nct id
    NCT02947685
    outcome key
    om-0003
    source section id
    NCT02947685-om-0003
    source outcome index
    3
    endpoint
    Objective Response Rate (OR: CR or PR)
    endpoint definition
    Defined as proportion of patients that achieve complete response (CR) or partial response (PR) according to RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
    time origin
    24 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients evaluated for disease
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-femara-ea5f0363
    nct id
    NCT02947685
    outcome key
    om-0004
    source section id
    NCT02947685-om-0004
    source outcome index
    4
    endpoint
    Duration of Response (DOR)
    endpoint definition
    Defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death from any cause, whichever occurs first
    time origin
    72 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients that achieved confirmed response
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-femara-ea5f0363
    nct id
    NCT02947685
    outcome key
    om-0005
    source section id
    NCT02947685-om-0005
    source outcome index
    5
    endpoint
    Clinical Benefit Rate
    endpoint definition
    The Clinical Benefit Rate (CBR) on each treatment arm will be estimated by dividing the number of patients with CR, PR, or SD/Non-CR and Non-PD (for patients with measurable disease) for ≥ 24 weeks by the number of patients randomized to the treatment arm.
    time origin
    24 months
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-femara-ea5f0363
    nct id
    NCT02947685
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm A
    regimen
    Palbociclib 125 mg daily and AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt)
    analyzed count
    261
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02947685-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-femara-ea5f0363
    nct id
    NCT02947685
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm B
    regimen
    AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant)
    analyzed count
    257
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02947685-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-femara-ea5f0363
    nct id
    NCT02947685
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm A
    regimen
    Palbociclib 125 mg daily and AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt)
    analyzed count
    261
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02947685-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-femara-ea5f0363
    nct id
    NCT02947685
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Arm B
    regimen
    AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant)
    analyzed count
    257
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02947685-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-femara-ea5f0363
    nct id
    NCT02947685
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm A
    regimen
    Palbociclib 125 mg daily and AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt)
    analyzed count
    261
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02947685-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-femara-ea5f0363
    nct id
    NCT02947685
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Arm B
    regimen
    AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant)
    analyzed count
    257
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02947685-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-femara-ea5f0363
    nct id
    NCT02947685
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Arm A
    regimen
    Palbociclib 125 mg daily and AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt)
    analyzed count
    231
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02947685-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-femara-ea5f0363
    nct id
    NCT02947685
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Arm B
    regimen
    AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant)
    analyzed count
    230
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02947685-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-femara-ea5f0363
    nct id
    NCT02947685
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Arm A
    regimen
    Palbociclib 125 mg daily and AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt)
    analyzed count
    76
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02947685-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-femara-ea5f0363
    nct id
    NCT02947685
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Arm B
    regimen
    AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant)
    analyzed count
    57
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02947685-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-femara-ea5f0363
    nct id
    NCT02947685
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Arm A
    regimen
    Palbociclib 125 mg daily and AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestratnt)
    analyzed count
    261
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02947685-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-femara-ea5f0363
    nct id
    NCT02947685
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Arm B
    regimen
    AntiHER2 Therapy (trastuzumab/pertuzumab) q3wks + Endocrine Therapy (letrozole, anastrozole, exemstane OR fulvestrant)
    analyzed count
    257
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02947685-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-femara-ea5f0363
    nct id
    NCT02947685
    harm key
    EG000
    source section id
    NCT02947685-ae
    event group key
    EG000
    event group label
    Arm A
    serious affected
    75
    serious at risk
    261
    other affected
    261
    other at risk
    261
    frequency threshold
    0
    collection period
    5 years for adverse events and 7 years 3 months for mortality
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-femara-ea5f0363
    nct id
    NCT02947685
    harm key
    EG001
    source section id
    NCT02947685-ae
    event group key
    EG001
    event group label
    Arm B
    serious affected
    54
    serious at risk
    257
    other affected
    234
    other at risk
    257
    frequency threshold
    0
    collection period
    5 years for adverse events and 7 years 3 months for mortality
    event definition
    Source null
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-femara-ea5f0363
    nct id
    NCT02947685
    qol key
    qol-0007
    source section id
    NCT02947685-om-0007
    source outcome index
    7
    instrument
    FACT
    instrument basis
    matched 'fact-b' in the study's own wording
    scale title
    Patient Reported Outcomes
    measure definition
    Time to symptom progression (FACT-B PFB-TOI), breast cancer specific health treatment related quality of life and general health status
    time frame
    24 months
    analysis role
    secondary
    reporting status
    NOT_POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice