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← TRODELVY: unresectable metastatic Breast cancer with PD-L1 stated without a specific alteration (first-line)

NCT03125902 · STUDY IN CONTEXT

A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)

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 is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (\>/=) 20 percent (%) relative increase and \>/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.

PD-L1-positive subpopulation: participants in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization

→

primary · POSTED

PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (\>/=) 20 percent (%) relative increase and \>/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.

ITT population: all randomized participants, whether or not the assigned study treatment was received

→

secondary · POSTED

OS is defined as the time from randomization to death from any cause. Results from a pre-specified interim analysis.

PD-L1-positive subpopulation: participants in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization

→

secondary · POSTED

OS is defined as the time from randomization to death from any cause. Results from a pre-specified interim analysis.

ITT population: all randomized participants, whether or not the assigned study treatment was received

→

secondary · POSTED

Percentage of Participants Who Are Alive at 12 and 18 Months

ITT population: all randomized participants, whether or not the assigned study treatment was received

→

secondary · POSTED

Deterioration in Global Health Status/HRQoL is defined as a decrease of at least 10 points on the Global Health Status /HRQoL scale (comprised of 2 items: 29 and 30) of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The 2 items use 7-point scale (1 = very poor to 7 = Excellent). Scores are averaged, transformed to 0-100 scale; where higher score=better level of functioning or greater degree of symptoms.

PRO-evaluable populations: participants in the ITT population with baseline PRO assessment and at least one post-baseline PRO assessment in the questionnaire of interest (European Organization for the Research and Treatment of Cancer \[EORTC\] Quality-of-life Questionnaire \[QLQ\] C30, EORTC QLQ BR-23 or FACT-G)

→

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 (HRQoL) in the PRO Evaluable Population

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-trodelvy-9f473052
nct id
NCT03125902
qol key
qol-0005
source section id
NCT03125902-om-0005
source outcome index
5
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 (HRQoL) in the PRO Evaluable Population
measure definition
Deterioration in Global Health Status/HRQoL is defined as a decrease of at least 10 points on the Global Health Status /HRQoL scale (comprised of 2 items: 29 and 30) of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The 2 items use 7-point scale (1 = very poor to 7 = Excellent). Scores are averaged, transformed to 0-100 scale; where higher score=better level of functioning or greater degree of symptoms.
time frame
From Day 1 to deterioration, assessed up 64 months
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher score=better
population note
PRO-evaluable populations: participants in the ITT population with baseline PRO assessment and at least one post-baseline PRO assessment in the questionnaire of interest (European Organization for the Research and Treatment of Cancer \[EORTC\] Quality-of-life Questionnaire \[QLQ\] C30, EORTC QLQ BR-23 or FACT-G)
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-trodelvy-9f473052
nct id
NCT03125902
trial label
A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)
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
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-trodelvy-9f473052
    nct id
    NCT03125902
    outcome key
    om-0000
    source section id
    NCT03125902-om-0000
    source outcome index
    0
    endpoint
    Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Subpopulation With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status
    endpoint definition
    PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (\>/=) 20 percent (%) relative increase and \>/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
    time origin
    From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    PD-L1-positive subpopulation: participants in the ITT population whose PD-L1 status was 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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-trodelvy-9f473052
    nct id
    NCT03125902
    outcome key
    om-0001
    source section id
    NCT03125902-om-0001
    source outcome index
    1
    endpoint
    Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population
    endpoint definition
    PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (\>/=) 20 percent (%) relative increase and \>/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
    time origin
    From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population: all randomized participants, 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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-trodelvy-9f473052
    nct id
    NCT03125902
    outcome key
    om-0002
    source section id
    NCT03125902-om-0002
    source outcome index
    2
    endpoint
    Overall Survival (OS) in the PD-L1-Positive Subpopulation
    endpoint definition
    OS is defined as the time from randomization to death from any cause. Results from a pre-specified interim analysis.
    time origin
    From Day 1 to death from any cause, assessed up 36 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    PD-L1-positive subpopulation: participants in the ITT population whose PD-L1 status was 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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-trodelvy-9f473052
    nct id
    NCT03125902
    outcome key
    om-0003
    source section id
    NCT03125902-om-0003
    source outcome index
    3
    endpoint
    Overall Survival (OS) in the ITT Population
    endpoint definition
    OS is defined as the time from randomization to death from any cause. Results from a pre-specified interim analysis.
    time origin
    From Day 1 to death from any cause, assessed up to end of study (up to approximately 36 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population: all randomized participants, 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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-trodelvy-9f473052
    nct id
    NCT03125902
    outcome key
    om-0004
    source section id
    NCT03125902-om-0004
    source outcome index
    4
    endpoint
    Percentage of Participants Who Are Alive at 12 and 18 Months
    endpoint definition
    Percentage of Participants Who Are Alive at 12 and 18 Months
    time origin
    From Day 1 to death from any cause, assessed up to 12 and 18 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    ITT population: all randomized participants, 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
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-trodelvy-9f473052
    nct id
    NCT03125902
    outcome key
    om-0005
    source section id
    NCT03125902-om-0005
    source outcome index
    5
    endpoint
    Time to Deterioration (TTD) in Global Health Status/ Health Related Quality of Life (HRQoL) in the PRO Evaluable Population
    endpoint definition
    Deterioration in Global Health Status/HRQoL is defined as a decrease of at least 10 points on the Global Health Status /HRQoL scale (comprised of 2 items: 29 and 30) of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The 2 items use 7-point scale (1 = very poor to 7 = Excellent). Scores are averaged, transformed to 0-100 scale; where higher score=better level of functioning or greater degree of symptoms.
    time origin
    From Day 1 to deterioration, assessed up 64 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    PRO-evaluable populations: participants in the ITT population with baseline PRO assessment and at least one post-baseline PRO assessment in the questionnaire of interest (European Organization for the Research and Treatment of Cancer \[EORTC\] Quality-of-life Questionnaire \[QLQ\] C30, EORTC QLQ BR-23 or FACT-G)
    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-trodelvy-9f473052
    nct id
    NCT03125902
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Placebo and Paclitaxel
    regimen
    Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    analyzed count
    101
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03125902-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-trodelvy-9f473052
    nct id
    NCT03125902
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Atezolizumab and Paclitaxel
    regimen
    Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    analyzed count
    191
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03125902-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-trodelvy-9f473052
    nct id
    NCT03125902
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Placebo and Paclitaxel
    regimen
    Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    analyzed count
    220
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03125902-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-trodelvy-9f473052
    nct id
    NCT03125902
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Atezolizumab and Paclitaxel
    regimen
    Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    analyzed count
    431
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03125902-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-trodelvy-9f473052
    nct id
    NCT03125902
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Placebo and Paclitaxel
    regimen
    Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    analyzed count
    101
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03125902-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-trodelvy-9f473052
    nct id
    NCT03125902
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Atezolizumab and Paclitaxel
    regimen
    Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    analyzed count
    191
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03125902-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-trodelvy-9f473052
    nct id
    NCT03125902
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Placebo and Paclitaxel
    regimen
    Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    analyzed count
    220
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03125902-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-trodelvy-9f473052
    nct id
    NCT03125902
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Atezolizumab and Paclitaxel
    regimen
    Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    analyzed count
    431
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03125902-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-trodelvy-9f473052
    nct id
    NCT03125902
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Placebo and Paclitaxel
    regimen
    Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    analyzed count
    220
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03125902-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-trodelvy-9f473052
    nct id
    NCT03125902
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Atezolizumab and Paclitaxel
    regimen
    Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    analyzed count
    431
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03125902-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-trodelvy-9f473052
    nct id
    NCT03125902
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Placebo and Paclitaxel
    regimen
    Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    analyzed count
    205
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03125902-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-trodelvy-9f473052
    nct id
    NCT03125902
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Atezolizumab and Paclitaxel
    regimen
    Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    analyzed count
    384
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03125902-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-trodelvy-9f473052
    nct id
    NCT03125902
    harm key
    EG000
    source section id
    NCT03125902-ae
    event group key
    EG000
    event group label
    Atezolizumab + Paclitaxel
    serious affected
    112
    serious at risk
    431
    other affected
    421
    other at risk
    431
    frequency threshold
    5
    collection period
    From baseline up to 64 months
    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-trodelvy-9f473052
    nct id
    NCT03125902
    harm key
    EG001
    source section id
    NCT03125902-ae
    event group key
    EG001
    event group label
    Placebo + Paclitaxel
    serious affected
    40
    serious at risk
    220
    other affected
    209
    other at risk
    220
    frequency threshold
    5
    collection period
    From baseline up to 64 months
    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-trodelvy-9f473052
    nct id
    NCT03125902
    qol key
    qol-0005
    source section id
    NCT03125902-om-0005
    source outcome index
    5
    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 (HRQoL) in the PRO Evaluable Population
    measure definition
    Deterioration in Global Health Status/HRQoL is defined as a decrease of at least 10 points on the Global Health Status /HRQoL scale (comprised of 2 items: 29 and 30) of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The 2 items use 7-point scale (1 = very poor to 7 = Excellent). Scores are averaged, transformed to 0-100 scale; where higher score=better level of functioning or greater degree of symptoms.
    time frame
    From Day 1 to deterioration, assessed up 64 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher score=better
    population note
    PRO-evaluable populations: participants in the ITT population with baseline PRO assessment and at least one post-baseline PRO assessment in the questionnaire of interest (European Organization for the Research and Treatment of Cancer \[EORTC\] Quality-of-life Questionnaire \[QLQ\] C30, EORTC QLQ BR-23 or FACT-G)
    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