A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Ca

Draft scope assessment: unclear. Attached because the study's own record names PD-L1 and describes metastatic disease. 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 was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first.

The ITT population is defined as all randomized patients, whether or not the assigned study treatment was received.

→

primary · POSTED

PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first.

The PD-L1-selected subpopulation is defined as patients in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization.

→

primary · POSTED

OS was defined as the time from the date of randomization to the date of death from any cause.

The ITT population is defined as all randomized patients, whether or not the assigned study treatment was received.

→

primary · POSTED

OS was defined as the time from the date of randomization to the date of death from any cause.

The PD-L1-selected subpopulation is defined as patients in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization.

→

secondary · POSTED

An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1.

The ORR-evaluable population is defined as patients in the ITT population with measurable disease at baseline.

→

secondary · POSTED

An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1.

The PD-L1-ORR-evaluable population is defined as patients in the PD-L1-selected subpopulation with measurable disease at baseline.

→

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

EORTC QLQ · Time to Deterioration (TTD) in Global Health Status/Health Related Quality of Life According to European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) v3.0 in All Randomized Participants

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-datroway-72478013
nct id: NCT02425891
qol key: qol-0008
source section id: NCT02425891-om-0008
source outcome index: 8
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: Time to Deterioration (TTD) in Global Health Status/Health Related Quality of Life According to European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) v3.0 in All Randomized Participants
measure definition: Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participant's GHS/HRQoL scale score showed a \>=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of \>= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of \>= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment.
time frame: Baseline up to approximately 58 months
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: The patient-reported outcome (PRO)-evaluable population is defined as patients in the ITT population with a baseline and ≥1 post-baseline PRO assessment.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

EORTC QLQ · TTD in Global Health Status/Health Related Quality of Life According to EORTC QLQ-C30 v3.0 in Participants With Detectable PD-L1

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-datroway-72478013
nct id: NCT02425891
qol key: qol-0009
source section id: NCT02425891-om-0009
source outcome index: 9
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: TTD in Global Health Status/Health Related Quality of Life According to EORTC QLQ-C30 v3.0 in Participants With Detectable PD-L1
measure definition: Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participants's GHS/HRQoL scale score showed a \>=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of \>= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of \>= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment.
time frame: Baseline up to approximately 58 months
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: The patient-reported outcome (PRO)-evaluable population is defined as patients in the ITT population with a baseline and ≥1 post-baseline 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-datroway-72478013
nct id: NCT02425891
trial label: A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Ca
applicability: unclear
applicability note: Attached because the study's own record names PD-L1 and describes metastatic disease. 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

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-datroway-72478013
nct id
NCT02425891
outcome key
om-0000
source section id
NCT02425891-om-0000
source outcome index
0
endpoint
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in All Randomized Participants
endpoint definition
PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first.
time origin
Baseline up to approximately 34 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The ITT population is defined as all randomized patients, whether or not the assigned study treatment was received.
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-datroway-72478013
nct id
NCT02425891
outcome key
om-0001
source section id
NCT02425891-om-0001
source outcome index
1
endpoint
PFS According to RECIST v1.1 in Participants With Detectable Programmed Death-Ligand 1 (PD-L1)
endpoint definition
PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first.
time origin
Baseline up to approximately 34 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The PD-L1-selected subpopulation is defined as patients in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization.
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-datroway-72478013
nct id
NCT02425891
outcome key
om-0002
source section id
NCT02425891-om-0002
source outcome index
2
endpoint
Overall Survival (OS) in All Randomized Participants
endpoint definition
OS was defined as the time from the date of randomization to the date of death from any cause.
time origin
Baseline until death due to any cause (up to approximately 58 months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The ITT population is defined as all randomized patients, whether or not the assigned study treatment was received.
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-datroway-72478013
nct id
NCT02425891
outcome key
om-0003
source section id
NCT02425891-om-0003
source outcome index
3
endpoint
OS in Participants With Detectable PD-L1
endpoint definition
OS was defined as the time from the date of randomization to the date of death from any cause.
time origin
Baseline until death due to any cause (up to approximately 58 months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The PD-L1-selected subpopulation is defined as patients in the ITT population whose PD-L1 status is IC1/2/3 at the time of randomization.
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-datroway-72478013
nct id
NCT02425891
outcome key
om-0004
source section id
NCT02425891-om-0004
source outcome index
4
endpoint
Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in All Randomized Participants
endpoint definition
An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1.
time origin
Baseline up to approximately 34 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The ORR-evaluable population is defined as patients in the ITT population with measurable disease at baseline.
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-datroway-72478013
nct id
NCT02425891
outcome key
om-0005
source section id
NCT02425891-om-0005
source outcome index
5
endpoint
Percentage of Participants With an Objective Response of CR or PR According to RECIST v1.1 in Participants With Detectable PD-L1
endpoint definition
An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1.
time origin
Baseline up to approximately 34 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The PD-L1-ORR-evaluable population is defined as patients in the PD-L1-selected subpopulation with measurable disease at baseline.
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-datroway-72478013
nct id
NCT02425891
outcome key
om-0000
arm key
OG000
arm label
Placebo Plus Nab-Paclitaxel
regimen
Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
analyzed count
451
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02425891-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-datroway-72478013
nct id
NCT02425891
outcome key
om-0000
arm key
OG001
arm label
Atezolizumab Plus Nab-Paclitaxel
regimen
Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
analyzed count
451
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02425891-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-datroway-72478013
nct id
NCT02425891
outcome key
om-0001
arm key
OG000
arm label
Placebo Plus Nab-Paclitaxel
regimen
Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
analyzed count
184
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02425891-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-datroway-72478013
nct id
NCT02425891
outcome key
om-0001
arm key
OG001
arm label
Atezolizumab Plus Nab-Paclitaxel
regimen
Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
analyzed count
185
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02425891-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-datroway-72478013
nct id
NCT02425891
outcome key
om-0002
arm key
OG000
arm label
Placebo Plus Nab-Paclitaxel
regimen
Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
analyzed count
451
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02425891-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-datroway-72478013
nct id
NCT02425891
outcome key
om-0002
arm key
OG001
arm label
Atezolizumab Plus Nab-Paclitaxel
regimen
Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
analyzed count
451
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02425891-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-datroway-72478013
nct id
NCT02425891
outcome key
om-0003
arm key
OG000
arm label
Placebo Plus Nab-Paclitaxel
regimen
Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
analyzed count
184
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02425891-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-datroway-72478013
nct id
NCT02425891
outcome key
om-0003
arm key
OG001
arm label
Atezolizumab Plus Nab-Paclitaxel
regimen
Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
analyzed count
185
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02425891-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-datroway-72478013
nct id
NCT02425891
outcome key
om-0004
arm key
OG000
arm label
Placebo Plus Nab-Paclitaxel
regimen
Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
analyzed count
449
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02425891-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-datroway-72478013
nct id
NCT02425891
outcome key
om-0004
arm key
OG001
arm label
Atezolizumab Plus Nab-Paclitaxel
regimen
Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
analyzed count
450
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02425891-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-datroway-72478013
nct id
NCT02425891
outcome key
om-0005
arm key
OG000
arm label
Placebo Plus Nab-Paclitaxel
regimen
Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
analyzed count
183
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02425891-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-datroway-72478013
nct id
NCT02425891
outcome key
om-0005
arm key
OG001
arm label
Atezolizumab Plus Nab-Paclitaxel
regimen
Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
analyzed count
185
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02425891-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-datroway-72478013
nct id
NCT02425891
harm key
EG000
source section id
NCT02425891-ae
event group key
EG000
event group label
Placebo (q2w) + Nab-Paclitaxel
serious affected
80
serious at risk
430
other affected
414
other at risk
430
frequency threshold
5
collection period
From the first study drug to the data cutoff date: 31 August 2021 (up to approximately 74 months)
event definition
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug. In placebo+nab-paclitaxel arm, 6 participants received atezolizumab in error \& 9 participants crossed over from placebo+nab-paclitaxel arm to atezolizumab+nab-paclitaxel arm.
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-datroway-72478013
nct id
NCT02425891
harm key
EG001
source section id
NCT02425891-ae
event group key
EG001
event group label
Atezolizumab (q2w) + Nab-Paclitaxel
serious affected
110
serious at risk
460
other affected
450
other at risk
460
frequency threshold
5
collection period
From the first study drug to the data cutoff date: 31 August 2021 (up to approximately 74 months)
event definition
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug. In placebo+nab-paclitaxel arm, 6 participants received atezolizumab in error \& 9 participants crossed over from placebo+nab-paclitaxel arm to atezolizumab+nab-paclitaxel arm.
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

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-datroway-72478013
nct id
NCT02425891
qol key
qol-0008
source section id
NCT02425891-om-0008
source outcome index
8
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Time to Deterioration (TTD) in Global Health Status/Health Related Quality of Life According to European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) v3.0 in All Randomized Participants
measure definition
Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participant's GHS/HRQoL scale score showed a \>=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of \>= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of \>= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment.
time frame
Baseline up to approximately 58 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The patient-reported outcome (PRO)-evaluable population is defined as patients in the ITT population with a baseline and ≥1 post-baseline PRO assessment.
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-datroway-72478013
nct id
NCT02425891
qol key
qol-0009
source section id
NCT02425891-om-0009
source outcome index
9
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
TTD in Global Health Status/Health Related Quality of Life According to EORTC QLQ-C30 v3.0 in Participants With Detectable PD-L1
measure definition
Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participants's GHS/HRQoL scale score showed a \>=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of \>= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of \>= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment.
time frame
Baseline up to approximately 58 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
The patient-reported outcome (PRO)-evaluable population is defined as patients in the ITT population with a baseline and ≥1 post-baseline 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