NCT02819518 · STUDY IN CONTEXT

Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (

Draft scope assessment: unclear. Attached because the study's own record describes recurrent 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

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

All randomly assigned participants who received at least 1 dose of study intervention were included in the group corresponding to the study intervention actually received. Four participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error: 3 participants received pembrolizumab + nab-paclitaxel and 1 received pembrolizumab + gemcitabine/carboplatin.

→

primary · POSTED

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.

→

primary · POSTED

Progression-free survival was defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on assessments by blinded independent central review (BICR) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.

Participants were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment

→

primary · POSTED

Progression-free survival was defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.

Participants with PD-L1 CPS ≥1 tumors were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment

→

primary · POSTED

Progression-free survival was defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.

Participants with PD-L1 CPS ≥10 tumors were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment

→

primary · POSTED

Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.

Participants were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

EORTC QLQ · Part 2: Change From Baseline to Week 15 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score- All Participants

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-recurrent-6bbbba73
nct id: NCT02819518
qol key: qol-0019
source section id: NCT02819518-om-0019
source outcome index: 19
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: Part 2: Change From Baseline to Week 15 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score- All Participants
measure definition: The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score are presented.
time frame: Baseline and Week 15
analysis role: secondary
reporting status: POSTED
higher is better: 1
direction quote: higher score indicates a better
population note: All randomized participants who received at least 1 dose of study intervention and had completed at least 1 patient-reported outcome (PRO) assessment. Participants were included in the treatment arm to which they were randomly assigned.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

EORTC QLQ · Part 2: Change From Baseline to Week 15 in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score - Participants With PD-L1 CPS ≥1 Tumors

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-recurrent-6bbbba73
nct id: NCT02819518
qol key: qol-0020
source section id: NCT02819518-om-0020
source outcome index: 20
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: Part 2: Change From Baseline to Week 15 in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score - Participants With PD-L1 CPS ≥1 Tumors
measure definition: The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score are presented.
time frame: Baseline and Week 15
analysis role: secondary
reporting status: POSTED
higher is better: 1
direction quote: higher score indicates a better
population note: All randomized participants with PD-L1 CPS ≥1 tumors who received at least 1 dose of study intervention and had completed at least 1 patient-reported outcome (PRO) assessment. Participants were included in the treatment arm to which they were randomly assigned.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

EORTC QLQ · Part 2: Change From Baseline to Week 15 in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score-Participants With PD-L1 CPS ≥10 Tumors

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-recurrent-6bbbba73
nct id: NCT02819518
qol key: qol-0021
source section id: NCT02819518-om-0021
source outcome index: 21
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: Part 2: Change From Baseline to Week 15 in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score-Participants With PD-L1 CPS ≥10 Tumors
measure definition: The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score are presented.
time frame: Baseline and Week 15
analysis role: secondary
reporting status: POSTED
higher is better: 1
direction quote: higher score indicates a better
population note: All randomized participants with PD-L1 CPS ≥10 tumors who received at least 1 dose of study intervention and had completed at least 1 patient-reported outcome (PRO) assessment. Participants were included in the treatment arm to which they were randomly assigned.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

EORTC QLQ · Part 2: Change From Baseline to Week 15 in Systemic Therapy Side Effects Using the EORTC Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23)-All Participants

Score direction: Lower 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-recurrent-6bbbba73
nct id: NCT02819518
qol key: qol-0022
source section id: NCT02819518-om-0022
source outcome index: 22
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: Part 2: Change From Baseline to Week 15 in Systemic Therapy Side Effects Using the EORTC Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23)-All Participants
measure definition: EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and four symptom scales (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptoms). Participant responses to 7 questions about their systemic therapy side effects were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score denotes worse symptoms for the systemic therapy side effects symptom scale. The change from baseline in systemic therapy side effects (EORTC QLQ-BR23 Items 1-4, 6, 7, and 8) score is presented.
time frame: Baseline and Week 15
analysis role: secondary
reporting status: POSTED
higher is better: 0
direction quote: higher score denotes worse
population note: All randomized participants who received at least 1 dose of study intervention and had completed at least 1 patient-reported outcome (PRO) assessment. Participants were included in the treatment arm to which they were randomly assigned.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

EORTC QLQ · Part 2: Change From Baseline to Week 15 in Systemic Therapy Side Effects Using the EORTC QLQ-BR23 - Participants With PD-L1 CPS ≥1 Tumors

Score direction: Lower 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-recurrent-6bbbba73
nct id: NCT02819518
qol key: qol-0023
source section id: NCT02819518-om-0023
source outcome index: 23
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: Part 2: Change From Baseline to Week 15 in Systemic Therapy Side Effects Using the EORTC QLQ-BR23 - Participants With PD-L1 CPS ≥1 Tumors
measure definition: EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and four symptom scales (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptoms). Participant responses to 7 questions about their systemic therapy side effects were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score denotes worse symptoms for the systemic therapy side effects symptom scale. The change from baseline in systemic therapy side effects (EORTC QLQ-BR23 Items 1-4, 6, 7, and 8) score is presented.
time frame: Baseline and Week 15
analysis role: secondary
reporting status: POSTED
higher is better: 0
direction quote: higher score denotes worse
population note: All randomized participants with PD-L1 CPS ≥1 tumors who received at least 1 dose of study intervention and had completed at least 1 patient-reported outcome (PRO) assessment. Participants were included in the treatment arm to which they were randomly assigned.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

EORTC QLQ · Part 2: Change From Baseline to Week 15 in Systemic Therapy Side Effects Using the EORTC QLQ-BR23- Participants With PD-L1 CPS ≥10 Tumors

Score direction: Lower 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-recurrent-6bbbba73
nct id: NCT02819518
qol key: qol-0024
source section id: NCT02819518-om-0024
source outcome index: 24
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: Part 2: Change From Baseline to Week 15 in Systemic Therapy Side Effects Using the EORTC QLQ-BR23- Participants With PD-L1 CPS ≥10 Tumors
measure definition: EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and four symptom scales (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptoms). Participant responses to 7 questions about their systemic therapy side effects are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score denotes worse symptoms for the systemic therapy side effects symptom scale. The change from baseline in systemic therapy side effects (EORTC QLQ-BR23 Items 1-4, 6, 7, and 8) score is presented.
time frame: Baseline and Week 15
analysis role: secondary
reporting status: POSTED
higher is better: 0
direction quote: higher score denotes worse
population note: All randomized participants with PD-L1 CPS ≥10 tumors who received at least 1 dose of study intervention and had completed at least 1 patient-reported outcome (PRO) assessment. Participants were included in the treatment arm to which they were randomly assigned.
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-recurrent-6bbbba73
nct id: NCT02819518
trial label: Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (
applicability: unclear
applicability note: Attached because the study's own record describes recurrent 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: 6
qol Count: 6

outcomes

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-recurrent-6bbbba73
nct id
NCT02819518
outcome key
om-0000
source section id
NCT02819518-om-0000
source outcome index
0
endpoint
Part 1: Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants
endpoint definition
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
time origin
Up to approximately 39 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All randomly assigned participants who received at least 1 dose of study intervention were included in the group corresponding to the study intervention actually received. Four participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error: 3 participants received pembrolizumab + nab-paclitaxel and 1 received pembrolizumab + gemcitabine/carboplatin.
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-recurrent-6bbbba73
nct id
NCT02819518
outcome key
om-0001
source section id
NCT02819518-om-0001
source outcome index
1
endpoint
Part 1: Percentage of Participants Who Discontinued Study Drug Due to an AE - All Participants
endpoint definition
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
time origin
Up to approximately 39 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All randomly assigned participants who received at least 1 dose of study intervention were included in the group corresponding to the study intervention actually received. Four participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error: 3 participants received pembrolizumab + nab-paclitaxel and 1 received pembrolizumab + gemcitabine/carboplatin.
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-recurrent-6bbbba73
nct id
NCT02819518
outcome key
om-0002
source section id
NCT02819518-om-0002
source outcome index
2
endpoint
Part 2: Progression-Free Survival (PFS) - All Participants
endpoint definition
Progression-free survival was defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on assessments by blinded independent central review (BICR) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.
time origin
Up to approximately 53 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Participants were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment
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-recurrent-6bbbba73
nct id
NCT02819518
outcome key
om-0003
source section id
NCT02819518-om-0003
source outcome index
3
endpoint
Part 2: PFS - Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 Tumors
endpoint definition
Progression-free survival was defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.
time origin
Up to approximately 53 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Participants with PD-L1 CPS ≥1 tumors were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment
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-recurrent-6bbbba73
nct id
NCT02819518
outcome key
om-0004
source section id
NCT02819518-om-0004
source outcome index
4
endpoint
Part 2: PFS - Participants With PD-L1 CPS ≥10 Tumors
endpoint definition
Progression-free survival was defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.
time origin
Up to approximately 53 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Participants with PD-L1 CPS ≥10 tumors were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment
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-recurrent-6bbbba73
nct id
NCT02819518
outcome key
om-0005
source section id
NCT02819518-om-0005
source outcome index
5
endpoint
Part 2: Overall Survival (OS) - All Participants
endpoint definition
Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.
time origin
Up to approximately 53 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Participants were analyzed in the treatment arm to which they were randomly assigned, regardless of whether they received treatment
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-recurrent-6bbbba73
nct id
NCT02819518
outcome key
om-0000
arm key
OG000
arm label
Part 1: Pembrolizumab + Nab-Paclitaxel
regimen
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02819518-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-recurrent-6bbbba73
nct id
NCT02819518
outcome key
om-0000
arm key
OG001
arm label
Part 1: Pembrolizumab + Paclitaxel
regimen
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02819518-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-recurrent-6bbbba73
nct id
NCT02819518
outcome key
om-0000
arm key
OG002
arm label
Part 1: Pembrolizumab + Gemcitabine/Carboplatin
regimen
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02819518-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-recurrent-6bbbba73
nct id
NCT02819518
outcome key
om-0001
arm key
OG000
arm label
Part 1: Pembrolizumab + Nab-Paclitaxel
regimen
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02819518-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-recurrent-6bbbba73
nct id
NCT02819518
outcome key
om-0001
arm key
OG001
arm label
Part 1: Pembrolizumab + Paclitaxel
regimen
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02819518-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-recurrent-6bbbba73
nct id
NCT02819518
outcome key
om-0001
arm key
OG002
arm label
Part 1: Pembrolizumab + Gemcitabine/Carboplatin
regimen
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02819518-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-recurrent-6bbbba73
nct id
NCT02819518
outcome key
om-0002
arm key
OG000
arm label
Part 2: Pembrolizumab + Chemotherapy
regimen
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to \~1 year).
analyzed count
566
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02819518-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-recurrent-6bbbba73
nct id
NCT02819518
outcome key
om-0002
arm key
OG001
arm label
Part 2: Placebo + Chemotherapy
regimen
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m\^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
analyzed count
281
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02819518-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-recurrent-6bbbba73
nct id
NCT02819518
outcome key
om-0003
arm key
OG000
arm label
Part 2: Pembrolizumab + Chemotherapy
regimen
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to \~1 year).
analyzed count
425
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02819518-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-recurrent-6bbbba73
nct id
NCT02819518
outcome key
om-0003
arm key
OG001
arm label
Part 2: Placebo + Chemotherapy
regimen
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m\^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
analyzed count
211
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02819518-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-recurrent-6bbbba73
nct id
NCT02819518
outcome key
om-0004
arm key
OG000
arm label
Part 2: Pembrolizumab + Chemotherapy
regimen
Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to \~1 year).
analyzed count
220
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02819518-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-recurrent-6bbbba73
nct id
NCT02819518
outcome key
om-0004
arm key
OG001
arm label
Part 2: Placebo + Chemotherapy
regimen
Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m\^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
analyzed count
103
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02819518-om-0004#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-recurrent-6bbbba73
nct id
NCT02819518
harm key
EG000
source section id
NCT02819518-ae
event group key
EG000
event group label
Part 1: Pembrolizumab + Nab-Paclitaxel
serious affected
3
serious at risk
13
other affected
13
other at risk
13
frequency threshold
5
collection period
Up to approximately 81 months
event definition
All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
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-recurrent-6bbbba73
nct id
NCT02819518
harm key
EG001
source section id
NCT02819518-ae
event group key
EG001
event group label
Part 1: Pembrolizumab + Paclitaxel
serious affected
4
serious at risk
10
other affected
10
other at risk
10
frequency threshold
5
collection period
Up to approximately 81 months
event definition
All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
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-recurrent-6bbbba73
nct id
NCT02819518
harm key
EG002
source section id
NCT02819518-ae
event group key
EG002
event group label
Part 1: Pembrolizumab + Gemcitabine/Carboplatin
serious affected
9
serious at risk
11
other affected
11
other at risk
11
frequency threshold
5
collection period
Up to approximately 81 months
event definition
All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
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-recurrent-6bbbba73
nct id
NCT02819518
harm key
EG003
source section id
NCT02819518-ae
event group key
EG003
event group label
Part 2: Pembrolizumab + Chemotherapy (First Course)
serious affected
169
serious at risk
562
other affected
551
other at risk
562
frequency threshold
5
collection period
Up to approximately 81 months
event definition
All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
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-recurrent-6bbbba73
nct id
NCT02819518
harm key
EG004
source section id
NCT02819518-ae
event group key
EG004
event group label
Part 2: Pembrolizumab + Chemotherapy (Second Course)
serious affected
3
serious at risk
12
other affected
11
other at risk
12
frequency threshold
5
collection period
Up to approximately 81 months
event definition
All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
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-recurrent-6bbbba73
nct id
NCT02819518
harm key
EG005
source section id
NCT02819518-ae
event group key
EG005
event group label
Part 2: Placebo + Chemotherapy
serious affected
68
serious at risk
281
other affected
273
other at risk
281
frequency threshold
5
collection period
Up to approximately 81 months
event definition
All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
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-recurrent-6bbbba73
nct id
NCT02819518
qol key
qol-0019
source section id
NCT02819518-om-0019
source outcome index
19
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Part 2: Change From Baseline to Week 15 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score- All Participants
measure definition
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score are presented.
time frame
Baseline and Week 15
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher score indicates a better
population note
All randomized participants who received at least 1 dose of study intervention and had completed at least 1 patient-reported outcome (PRO) assessment. Participants were included in the treatment arm to which they were randomly assigned.
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-recurrent-6bbbba73
nct id
NCT02819518
qol key
qol-0020
source section id
NCT02819518-om-0020
source outcome index
20
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Part 2: Change From Baseline to Week 15 in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score - Participants With PD-L1 CPS ≥1 Tumors
measure definition
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score are presented.
time frame
Baseline and Week 15
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher score indicates a better
population note
All randomized participants with PD-L1 CPS ≥1 tumors who received at least 1 dose of study intervention and had completed at least 1 patient-reported outcome (PRO) assessment. Participants were included in the treatment arm to which they were randomly assigned.
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-recurrent-6bbbba73
nct id
NCT02819518
qol key
qol-0021
source section id
NCT02819518-om-0021
source outcome index
21
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Part 2: Change From Baseline to Week 15 in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score-Participants With PD-L1 CPS ≥10 Tumors
measure definition
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score are presented.
time frame
Baseline and Week 15
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher score indicates a better
population note
All randomized participants with PD-L1 CPS ≥10 tumors who received at least 1 dose of study intervention and had completed at least 1 patient-reported outcome (PRO) assessment. Participants were included in the treatment arm to which they were randomly assigned.
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-recurrent-6bbbba73
nct id
NCT02819518
qol key
qol-0022
source section id
NCT02819518-om-0022
source outcome index
22
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Part 2: Change From Baseline to Week 15 in Systemic Therapy Side Effects Using the EORTC Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23)-All Participants
measure definition
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and four symptom scales (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptoms). Participant responses to 7 questions about their systemic therapy side effects were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score denotes worse symptoms for the systemic therapy side effects symptom scale. The change from baseline in systemic therapy side effects (EORTC QLQ-BR23 Items 1-4, 6, 7, and 8) score is presented.
time frame
Baseline and Week 15
analysis role
secondary
reporting status
POSTED
higher is better
0
direction quote
higher score denotes worse
population note
All randomized participants who received at least 1 dose of study intervention and had completed at least 1 patient-reported outcome (PRO) assessment. Participants were included in the treatment arm to which they were randomly assigned.
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-recurrent-6bbbba73
nct id
NCT02819518
qol key
qol-0023
source section id
NCT02819518-om-0023
source outcome index
23
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Part 2: Change From Baseline to Week 15 in Systemic Therapy Side Effects Using the EORTC QLQ-BR23 - Participants With PD-L1 CPS ≥1 Tumors
measure definition
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and four symptom scales (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptoms). Participant responses to 7 questions about their systemic therapy side effects were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score denotes worse symptoms for the systemic therapy side effects symptom scale. The change from baseline in systemic therapy side effects (EORTC QLQ-BR23 Items 1-4, 6, 7, and 8) score is presented.
time frame
Baseline and Week 15
analysis role
secondary
reporting status
POSTED
higher is better
0
direction quote
higher score denotes worse
population note
All randomized participants with PD-L1 CPS ≥1 tumors who received at least 1 dose of study intervention and had completed at least 1 patient-reported outcome (PRO) assessment. Participants were included in the treatment arm to which they were randomly assigned.
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-recurrent-6bbbba73
nct id
NCT02819518
qol key
qol-0024
source section id
NCT02819518-om-0024
source outcome index
24
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Part 2: Change From Baseline to Week 15 in Systemic Therapy Side Effects Using the EORTC QLQ-BR23- Participants With PD-L1 CPS ≥10 Tumors
measure definition
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective) and four symptom scales (systemic therapy side effects, upset by hair loss, arm symptoms, breast symptoms). Participant responses to 7 questions about their systemic therapy side effects are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score denotes worse symptoms for the systemic therapy side effects symptom scale. The change from baseline in systemic therapy side effects (EORTC QLQ-BR23 Items 1-4, 6, 7, and 8) score is presented.
time frame
Baseline and Week 15
analysis role
secondary
reporting status
POSTED
higher is better
0
direction quote
higher score denotes worse
population note
All randomized participants with PD-L1 CPS ≥10 tumors who received at least 1 dose of study intervention and had completed at least 1 patient-reported outcome (PRO) assessment. Participants were included in the treatment arm to which they were randomly assigned.
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