Skip to content
Triangle logo TriangleGet started
← Herceptin Hylecta: metastatic Breast cancer with HER2 stated without a specific alteration (first-line) after prior therapy

NCT01740427 · STUDY IN CONTEXT

A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)

Draft scope assessment: unclear. Attached because the study's own record names HER2. 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 is defined as the time from the date of randomization to the date of the first documentation of objective tumor progression as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death due to any cause in the absence of documented PD, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date - randomization date +1)/30.4. Progression is defined using RECIST v1.1, as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions, or the appearance of new lesions.

ITT population or full analysis set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study medication or received a different drug from that to which they were randomized.

→

secondary · POSTED

Objective Response (OR) defined as overall complete response (CR) or partial response (PR) according to RECIST v1.1. Objective Response Rate (ORR) is defined as proportion of participants with CR or PR relative to all randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment, or who died, progressed/ dropped out for any reason prior to reaching a CR or PR were counted as non-responders in assessment of ORR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \<10mm). PR: \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.

ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized.

→

secondary · POSTED

The OR is defined as the overall CR or PR according to the RECIST v1.1. ORR is defined as proportion of participants with CR or PR relative to all randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment, or who died, progressed/ dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the assessment of ORR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \<10mm). PR: \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.

Participants who had measurable disease at baseline.

→

secondary · POSTED

DR is defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurs first. If tumor progression data included more than 1 date, the first date will be used. DR was calculated as \[the date response ended (i.e. date of PD or death) - first CR or PR date + 1)\]/30.4. DR would only be calculated for the subgroup of participants with an objective tumor response. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \<10mm). PR: \>=30% decrease under baseline of the sum of diameters of all target measurable lesions.The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.

Participants who had tumor response with CR or PR during study.

→

secondary · POSTED

DC is defined as overall CR, PR, or stable disease (SD) \>=24 weeks according to RECIST version 1.1. Disease Control Rate (DCR) is defined as participants with CR, PR, or SD \>=24 weeks relative to all randomized participants. Participants who do not have on-study radiographic tumor reevaluation, who received anti-tumor treatment, a best response of SD\>=24 weeks, or who died, progressed, or dropped out for any reason prior to achieving reaching a CR or PR and a best response of SD\>=24 weeks was counted as non-responders in DCR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \<10mm). PR: \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. SD: neither sufficient shrinkage nor increase to qualify for disease progression.

ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized.

→

secondary · POSTED

PFS by biomarker status by Investigator assessment. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Positive is defined as H-Score \>=1 and negative as H-Score \<1. H-Score is calculated as the sum of the % of cells at each level of staining intensity (0, 1+, 2+, and 3+) multiplied by the staining intensity value: H-Score = (% at 0)\*0 + (% at 1+)\*1 + (% at 2+)\*2 + (% at 3+)\*3. H-Score values range from 0 to 300. ER stands for estrogen receptor and Rb stands for retinoblastoma susceptibility gene product.

ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized. Here "Number Analyzed" signifies number of participants evaluable for specified rows.

→

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

EQ-5D · Change From Baseline Between Treatment Comparison in Euro Quality of Life (EQ-5D) Index

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-herceptin-hylecta-6ea26642
nct id
NCT01740427
qol key
qol-0009
source section id
NCT01740427-om-0009
source outcome index
9
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Change From Baseline Between Treatment Comparison in Euro Quality of Life (EQ-5D) Index
measure definition
The EuroQol EQ-5D is a 6-item instrument designed to assess health status in terms of a single index value or utility score. It contains 5 descriptors of current health state (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with each dimension having 3 levels of function (1=no problem, 2=some problem, and 3=extreme problem). The scores on the 5 descriptors are summarized to create a single summary score. An overall utility score is calculated based on these domains, with a range score from 0 (worse health scenario) to a maximum of 1.0 (best health scenario).
time frame
From Baseline up to 2.5 years
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Patient Reported Outcome (PRO) Analysis Set is a subset of ITT participants, who had both baseline and at least one follow-up PRO assessment.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · Change From Baseline Between Treatment Comparison in Functional Assessment of Cancer Therapy-Breast (FACT-B)

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-herceptin-hylecta-6ea26642
nct id
NCT01740427
qol key
qol-0010
source section id
NCT01740427-om-0010
source outcome index
10
instrument
FACT
instrument basis
matched 'fact-b' in the study's own wording
scale title
Change From Baseline Between Treatment Comparison in Functional Assessment of Cancer Therapy-Breast (FACT-B)
measure definition
FACT is a modular approach to assess participant health-related quality of life using a 'core' set of questions (FACT-G) as well as a cancer site-specific module. The FACT-G is a 27-item compilation of general questions divided into 4 domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. The FACT-B consisted of the FACT-G (27-item) and a breast-specific module: a 10-item instrument designed to assess participant concerns relating to breast cancer. For all questions, participants were asked to respond to a five-level scale where 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. FACT-B total score = Physical Well-Being + Social/Family Well-Being + Emotional Well-Being + Functional Well-Being + Breast Cancer Subscale. As each of the items ranges from 0-4, the range of possible scores is 0-144, with 0 being the worst possible score and 144 the best.
time frame
From Baseline up to 2.5 years
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Patient Reported Outcome (PRO) Analysis Set is a subset of ITT participants, who had both baseline and at least one follow-up PRO assessment.
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-herceptin-hylecta-6ea26642
nct id
NCT01740427
trial label
A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)
applicability
unclear
applicability note
Attached because the study's own record names HER2. 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
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-6ea26642
    nct id
    NCT01740427
    outcome key
    om-0000
    source section id
    NCT01740427-om-0000
    source outcome index
    0
    endpoint
    Progression-Free Survival (PFS) as Assessed by the Investigator
    endpoint definition
    PFS is defined as the time from the date of randomization to the date of the first documentation of objective tumor progression as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death due to any cause in the absence of documented PD, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date - randomization date +1)/30.4. Progression is defined using RECIST v1.1, as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions, or the appearance of new lesions.
    time origin
    From randomization date to date of first documentation of progression or death (up to approximately 2.5 years)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population or full analysis set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study medication or received a different drug from that to which they were randomized.
    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-herceptin-hylecta-6ea26642
    nct id
    NCT01740427
    outcome key
    om-0001
    source section id
    NCT01740427-om-0001
    source outcome index
    1
    endpoint
    Objective Response as Assessed by the Investigator
    endpoint definition
    Objective Response (OR) defined as overall complete response (CR) or partial response (PR) according to RECIST v1.1. Objective Response Rate (ORR) is defined as proportion of participants with CR or PR relative to all randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment, or who died, progressed/ dropped out for any reason prior to reaching a CR or PR were counted as non-responders in assessment of ORR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \<10mm). PR: \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.
    time origin
    From randomization until end of treatment (up to approximately 2.5 years)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized.
    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-herceptin-hylecta-6ea26642
    nct id
    NCT01740427
    outcome key
    om-0002
    source section id
    NCT01740427-om-0002
    source outcome index
    2
    endpoint
    Objective Response: Participants With Measurable Disease at Baseline as Assessed by the Investigator
    endpoint definition
    The OR is defined as the overall CR or PR according to the RECIST v1.1. ORR is defined as proportion of participants with CR or PR relative to all randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment, or who died, progressed/ dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the assessment of ORR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \<10mm). PR: \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.
    time origin
    From randomization until end of treatment (up to approximately 2.5 years)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants who had measurable disease at baseline.
    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-herceptin-hylecta-6ea26642
    nct id
    NCT01740427
    outcome key
    om-0003
    source section id
    NCT01740427-om-0003
    source outcome index
    3
    endpoint
    Duration of Response (DR)
    endpoint definition
    DR is defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurs first. If tumor progression data included more than 1 date, the first date will be used. DR was calculated as \[the date response ended (i.e. date of PD or death) - first CR or PR date + 1)\]/30.4. DR would only be calculated for the subgroup of participants with an objective tumor response. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \<10mm). PR: \>=30% decrease under baseline of the sum of diameters of all target measurable lesions.The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.
    time origin
    From randomization until end of treatment (up to approximately 2.5 years)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants who had tumor response with CR or PR during study.
    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-herceptin-hylecta-6ea26642
    nct id
    NCT01740427
    outcome key
    om-0004
    source section id
    NCT01740427-om-0004
    source outcome index
    4
    endpoint
    Disease Control (DC)/Clinical Benefit Response (CBR)
    endpoint definition
    DC is defined as overall CR, PR, or stable disease (SD) \>=24 weeks according to RECIST version 1.1. Disease Control Rate (DCR) is defined as participants with CR, PR, or SD \>=24 weeks relative to all randomized participants. Participants who do not have on-study radiographic tumor reevaluation, who received anti-tumor treatment, a best response of SD\>=24 weeks, or who died, progressed, or dropped out for any reason prior to achieving reaching a CR or PR and a best response of SD\>=24 weeks was counted as non-responders in DCR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis \<10mm). PR: \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. SD: neither sufficient shrinkage nor increase to qualify for disease progression.
    time origin
    From randomization until end of treatment (up to approximately 2.5 years)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized.
    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-herceptin-hylecta-6ea26642
    nct id
    NCT01740427
    outcome key
    om-0005
    source section id
    NCT01740427-om-0005
    source outcome index
    5
    endpoint
    PFS by Tumor Tissue Biomarkers Status, Including Genes (eg, Copy Numbers of CCND1, CDKN2A), Proteins (eg, Ki67, pRb), and RNA Expression (eg, cdk4, cdk6)
    endpoint definition
    PFS by biomarker status by Investigator assessment. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Positive is defined as H-Score \>=1 and negative as H-Score \<1. H-Score is calculated as the sum of the % of cells at each level of staining intensity (0, 1+, 2+, and 3+) multiplied by the staining intensity value: H-Score = (% at 0)\*0 + (% at 1+)\*1 + (% at 2+)\*2 + (% at 3+)\*3. H-Score values range from 0 to 300. ER stands for estrogen receptor and Rb stands for retinoblastoma susceptibility gene product.
    time origin
    From randomization until end of treatment (up to approximately 24 Months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized. Here "Number Analyzed" signifies number of participants evaluable for specified rows.
    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-herceptin-hylecta-6ea26642
    nct id
    NCT01740427
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Palbociclib Plus Letrozole
    regimen
    Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
    analyzed count
    444
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01740427-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-6ea26642
    nct id
    NCT01740427
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo Plus Letrozole
    regimen
    Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
    analyzed count
    222
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01740427-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-6ea26642
    nct id
    NCT01740427
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Palbociclib Plus Letrozole
    regimen
    Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
    analyzed count
    444
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01740427-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-6ea26642
    nct id
    NCT01740427
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo Plus Letrozole
    regimen
    Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
    analyzed count
    222
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01740427-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-6ea26642
    nct id
    NCT01740427
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Palbociclib Plus Letrozole
    regimen
    Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
    analyzed count
    338
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01740427-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-6ea26642
    nct id
    NCT01740427
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Placebo Plus Letrozole
    regimen
    Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
    analyzed count
    171
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01740427-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-6ea26642
    nct id
    NCT01740427
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Palbociclib Plus Letrozole
    regimen
    Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
    analyzed count
    206
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01740427-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-6ea26642
    nct id
    NCT01740427
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Placebo Plus Letrozole
    regimen
    Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
    analyzed count
    85
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01740427-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-6ea26642
    nct id
    NCT01740427
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Palbociclib Plus Letrozole
    regimen
    Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
    analyzed count
    444
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01740427-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-6ea26642
    nct id
    NCT01740427
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Placebo Plus Letrozole
    regimen
    Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
    analyzed count
    222
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01740427-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-6ea26642
    nct id
    NCT01740427
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Palbociclib Plus Letrozole
    regimen
    Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
    analyzed count
    444
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01740427-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-6ea26642
    nct id
    NCT01740427
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Placebo Plus Letrozole
    regimen
    Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
    analyzed count
    222
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01740427-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-herceptin-hylecta-6ea26642
    nct id
    NCT01740427
    harm key
    EG000
    source section id
    NCT01740427-ae
    event group key
    EG000
    event group label
    Palbociclib Plus Letrozole
    serious affected
    125
    serious at risk
    444
    other affected
    435
    other at risk
    444
    frequency threshold
    5
    collection period
    From the date of randomization up to 28 days after last dose of study medication (final analysis till study completion, approximately up to 10.51 years)
    event definition
    Same event may appear as non-SAE and SAE but are distinct events. Event may be an SAE in 1 participant and non-SAE in other, or participant may have both non-SAE and SAE. AT population included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.
    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-herceptin-hylecta-6ea26642
    nct id
    NCT01740427
    harm key
    EG001
    source section id
    NCT01740427-ae
    event group key
    EG001
    event group label
    Placebo Plus Letrozole
    serious affected
    38
    serious at risk
    222
    other affected
    209
    other at risk
    222
    frequency threshold
    5
    collection period
    From the date of randomization up to 28 days after last dose of study medication (final analysis till study completion, approximately up to 10.51 years)
    event definition
    Same event may appear as non-SAE and SAE but are distinct events. Event may be an SAE in 1 participant and non-SAE in other, or participant may have both non-SAE and SAE. AT population included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.
    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-herceptin-hylecta-6ea26642
    nct id
    NCT01740427
    qol key
    qol-0009
    source section id
    NCT01740427-om-0009
    source outcome index
    9
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Change From Baseline Between Treatment Comparison in Euro Quality of Life (EQ-5D) Index
    measure definition
    The EuroQol EQ-5D is a 6-item instrument designed to assess health status in terms of a single index value or utility score. It contains 5 descriptors of current health state (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with each dimension having 3 levels of function (1=no problem, 2=some problem, and 3=extreme problem). The scores on the 5 descriptors are summarized to create a single summary score. An overall utility score is calculated based on these domains, with a range score from 0 (worse health scenario) to a maximum of 1.0 (best health scenario).
    time frame
    From Baseline up to 2.5 years
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Patient Reported Outcome (PRO) Analysis Set is a subset of ITT participants, who had both baseline and at least one follow-up PRO assessment.
    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-herceptin-hylecta-6ea26642
    nct id
    NCT01740427
    qol key
    qol-0010
    source section id
    NCT01740427-om-0010
    source outcome index
    10
    instrument
    FACT
    instrument basis
    matched 'fact-b' in the study's own wording
    scale title
    Change From Baseline Between Treatment Comparison in Functional Assessment of Cancer Therapy-Breast (FACT-B)
    measure definition
    FACT is a modular approach to assess participant health-related quality of life using a 'core' set of questions (FACT-G) as well as a cancer site-specific module. The FACT-G is a 27-item compilation of general questions divided into 4 domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. The FACT-B consisted of the FACT-G (27-item) and a breast-specific module: a 10-item instrument designed to assess participant concerns relating to breast cancer. For all questions, participants were asked to respond to a five-level scale where 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. FACT-B total score = Physical Well-Being + Social/Family Well-Being + Emotional Well-Being + Functional Well-Being + Breast Cancer Subscale. As each of the items ranges from 0-4, the range of possible scores is 0-144, with 0 being the worst possible score and 144 the best.
    time frame
    From Baseline up to 2.5 years
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Patient Reported Outcome (PRO) Analysis Set is a subset of ITT participants, who had both baseline and at least one follow-up PRO assessment.
    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