Trial from ClinicalTrials.gov

For full trial details, please see the original record at



Trial ID
NCT02425891
Ethics application status
Date submitted
21/04/2015
Date registered
21/04/2015
Date last updated
1/08/2017

Titles & IDs
Public title
A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130)
Scientific title
A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer
Secondary ID [1] 0 0
2014-005490-37
Secondary ID [2] 0 0
WO29522
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Triple Negative Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: drugs - Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
Treatment: drugs - Nab-Paclitaxel
Treatment: drugs - Placebo

Experimental: Atezolizumab Plus Nab-Paclitaxel - Participants assigned to atezolizumab plus nab-paclitaxel will receive both agents until loss of clinical benefit, unacceptable toxicity, symptomatic deterioration attributed to disease progression, or death.

Placebo Comparator: Placebo Plus Nab-Paclitaxel - Participants assigned to placebo plus nab-paclitaxel will receive both agents until loss of clinical benefit, unacceptable toxicity, symptomatic deterioration attributed to disease progression, or death.


Treatment: drugs: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
Atezolizumab at a fixed dose of 840 milligrams via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, symptomatic deterioration attributed to disease progression, or death.

Treatment: drugs: Nab-Paclitaxel
Nab-Paclitaxel at a starting dose of 100 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle. Nab-Paclitaxel will be administered for a target of at least 6 cycles, with no maximum in the absence of disease progression or unacceptable toxicity.

Treatment: drugs: Placebo
Placebo administered via IV infusion on Days 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, symptomatic deterioration attributed to disease progression, or death.

Intervention code [1] 0 0
Treatment: drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in all Randomized Participants
Timepoint [1] 0 0
Baseline up to 53 months (assessed at Screening, every 8 weeks for the first 12 months, thereafter every 12 weeks until disease progression or death, whichever occurs first)
Primary outcome [2] 0 0
PFS According to RECIST v1.1 in Participants with Detectable Programmed Death-Ligand 1 (PD-L1)
Timepoint [2] 0 0
Baseline up to 53 months (assessed at Screening, every 8 weeks for the first 12 months, thereafter every 12 weeks until disease progression or death, whichever occurs first)
Primary outcome [3] 0 0
Overall Survival (OS) in all Randomized Participants
Timepoint [3] 0 0
Baseline until death due to any cause (up to 53 months)
Primary outcome [4] 0 0
OS in Participants with Detectable PD-L1
Timepoint [4] 0 0
Baseline until death due to any cause (up to 53 months)
Secondary outcome [1] 0 0
Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in all Randomized Participants
Timepoint [1] 0 0
Baseline up to 53 months (assessed at Screening, every 8 weeks for the first 12 months, thereafter every 12 weeks until disease progression or death, whichever occurs first)
Secondary outcome [2] 0 0
Percentage of Participants With an Objective Response of CR or PR According to RECIST v1.1 in Participants with Detectable PD-L1
Timepoint [2] 0 0
Baseline up to 53 months (assessed at Screening, every 8 weeks for the first 12 months, thereafter every 12 weeks until disease progression or death, whichever occurs first)
Secondary outcome [3] 0 0
Duration of Response (DOR) According to RECIST v1.1 in all Randomized Participants
Timepoint [3] 0 0
Baseline up to 53 months (assessed at Screening, every 8 weeks for the first 12 months, thereafter every 12 weeks until disease progression or death, whichever occurs first)
Secondary outcome [4] 0 0
DOR Acccording to RECIST v1.1 in Participants with Detectable PD-L1
Timepoint [4] 0 0
Baseline up to 53 months (assessed at Screening, every 8 weeks for the first 12 months, thereafter every 12 weeks until disease progression or death, whichever occurs first)
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Baseline up to 53 months (assessed at Day 1 of each cycle up to treatment discontinuation [approximately 53 months], every 28 days after treatment discontinuation for 1 year [overall approximately 53 months]) (cycle = 28 days)
Secondary outcome [6] 0 0
TTD in Global Health Status/Health Related Quality of Life According to EORTC QLQ-C30 v3.0 in Participants with Detectable PD-L1
Timepoint [6] 0 0
Baseline up to 53 months (assessed at Day 1 of each cycle up to treatment discontinuation [approximately 53 months], every 28 days after treatment discontinuation for 1 year [overall approximately 53 months]) (cycle = 28 days)
Secondary outcome [7] 0 0
Percentage of Participants with Adverse Events (AEs) or Serious AEs (SAEs)
Timepoint [7] 0 0
Baseline up to 53 months
Secondary outcome [8] 0 0
Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
Timepoint [8] 0 0
Baseline up to 53 months (assessed at pre-dose [Hour 0] on Day 1 of Cycles 1, 2, 3, 4, 8, 16, and every 8 cycles thereafter up to treatment discontinuation [approximately 53 months], 120 days after last dose [approximately 53 months]) (Cycle = 28 days)
Secondary outcome [9] 0 0
Maximum Serum Concentration (Cmax) for Atezolizumab - Pre-dose (Hour 0), 30 minutes after end of atezolizumab infusion (infusion duration = 60 minutes) on Cycle 1 Day 1; pre-dose (Hour 0) on Day 1 of Cycles 2, 3, 4, 8, 16, and every 8 cycles thereafter up to treatment discontinuation (approximately 53 months), 120 days after last dose (approximately 53 months) (Cycle = 28 days)
Timepoint [9] 0 0
Pre-dose (Hour 0) on Cycle 1 Day 1 up to 53 months (detailed timeframe is provided in outcome description section)
Secondary outcome [10] 0 0
Minimum Serum Concentration (Cmin) for Atezolizumab - Pre-dose (Hour 0), 30 minutes after end of atezolizumab infusion (infusion duration = 60 minutes) on Cycle 1 Day 1; pre-dose (Hour 0) on Day 1 of Cycles 2, 3, 4, 8, 16, and every 8 cycles thereafter up to treatment discontinuation (approximately 53 months), 120 days after last dose (approximately 53 months) (Cycle = 28 days)
Timepoint [10] 0 0
Pre-dose (Hour 0) on Cycle 1 Day 1 up to 53 months (detailed timeframe is provided in outcome description section)
Secondary outcome [11] 0 0
Plasma Concentrations of Total Paclitaxel
Timepoint [11] 0 0
Pre-dose (Hour 0) on Cycle 1 Day 1, pre-dose (Hour 0), 5-10 minutes before end of nab-paclitaxel infusion, 1 hour after end of nab-paclitaxel infusion (infusion duration = 30 minutes) on Cycle 3 Day 1 (Cycle = 28 days)

Eligibility
Key inclusion criteria
- Metastatic or locally advanced, histologically documented TNBC characterized by
absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and
progesterone receptor (PR) expression

- No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or
metastatic TNBC

- Eligible for taxane monotherapy (i.e., absence of rapid clinical progression,
life-threatening visceral metastases, or the need for rapid symptom and/or disease
control)

- A representative formalin-fixed, paraffin-embedded tumor specimen in paraffin blocks,
or at least 20 unstained slides with an associated pathology report documenting ER,
PR, and HER2 negativity. Participants with fewer than 20 unstained slides available at
baseline, and not fewer than 12 unstained slides will be eligible upon discussion with
Medical Monitor

- Eastern Cooperative Oncology Group performance status of 0 or 1

- Measurable disease as defined by RECIST v1.1

- Adequate hematologic and end-organ function
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Known central nervous system (CNS) disease, except for treated asymptomatic CNS
metastases

- Leptomeningeal disease

- Pregnancy or lactation

- History of autoimmune disease

- Prior allogeneic stem cell or solid organ transplantation

- Positive test for human immunodeficiency virus

- Active hepatitis B or hepatitis C

- Receipt of a live, attenuated vaccine within 4 weeks prior to randomization, during
treatment, or within 5 months following the last dose of atezolizumab/placebo

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Nepean Cancer Care Centre - Sydney
Recruitment hospital [3] 0 0
Icon Cancer Foundation - South Brisbane
Recruitment hospital [4] 0 0
Princess Alexandra Hospital; Division of Cancer Services - Woolloongabba
Recruitment hospital [5] 0 0
Peninsula and South Eastern Haematology and Oncology Grou - Frankston
Recruitment hospital [6] 0 0
Peter MacCallum Cancer Centre; Medical Oncology - Melbourne
Recruitment hospital [7] 0 0
Sunshine Hospital - St Albans
Recruitment hospital [8] 0 0
St John of God Hospital; Bendat Cancer Centre - Subiaco
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2747 - Sydney
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
3000 - Melbourne
Recruitment postcode(s) [7] 0 0
3021 - St Albans
Recruitment postcode(s) [8] 0 0
6008 - Subiaco
Recruitment outside Australia
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Michigan
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Mississippi
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Bruxelles
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Besancon
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Lille
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Lyon
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Nantes
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Dortmund
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Essen
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Georgsmarienhütte
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Halle
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Hamburg
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Hannover
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Heidelberg
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Lübeck
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Magdeburg
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München
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Münster
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Nordhausen
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Recklinghausen
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Rostock
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Germany
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Trier
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Germany
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Troisdorf
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Germany
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Tübingen
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Greece
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Athens
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Greece
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Heraklion
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Greece
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Patras
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Greece
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Thessaloniki
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Guatemala
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Guatemala City
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Hong Kong
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Hong Kong
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Hungary
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Budapest
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Hungary
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Szeged
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Italy
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Campania
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Italy
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Lombardia
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Italy
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Puglia
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Italy
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Toscana
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Japan
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Aichi
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Japan
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Ehime
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Japan
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Fukushima
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Japan
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Gunma
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Japan
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Hiroshima
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Isehara-shi
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Japan
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Kagoshima
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Japan
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Kanagawa
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Japan
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Kumamoto
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Japan
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Kyoto
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Japan
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Mie
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Japan
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Miyagi
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Japan
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Niigata-shi
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Japan
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Okayama
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Japan
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Okinawa
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Shizuoka-shi
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Japan
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Shizuoka
Country [143] 0 0
Japan
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Tokyo
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Korea, Republic of
State/province [144] 0 0
Gyeonggi-do
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Korea, Republic of
State/province [145] 0 0
Seoul
Country [146] 0 0
Latvia
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Daugavpils
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Latvia
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Riga
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Mexico
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Nuevo Leon
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Mexico
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Colima
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Mexico
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D.f.
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Mexico
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Mexico City
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Norway
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Bergen
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Norway
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Kristiansand
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Norway
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Stavanger
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Panama
State/province [155] 0 0
Panama
Country [156] 0 0
Poland
State/province [156] 0 0
Bydgoszcz
Country [157] 0 0
Poland
State/province [157] 0 0
Gdynia
Country [158] 0 0
Poland
State/province [158] 0 0
Konin
Country [159] 0 0
Poland
State/province [159] 0 0
Krakow
Country [160] 0 0
Poland
State/province [160] 0 0
Lublin
Country [161] 0 0
Poland
State/province [161] 0 0
Warszawa
Country [162] 0 0
Poland
State/province [162] 0 0
Wieliszew
Country [163] 0 0
Romania
State/province [163] 0 0
Iasi
Country [164] 0 0
Romania
State/province [164] 0 0
Timisoara
Country [165] 0 0
Russian Federation
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Moskovskaja Oblast
Country [166] 0 0
Russian Federation
State/province [166] 0 0
Arkhangelsk
Country [167] 0 0
Russian Federation
State/province [167] 0 0
Ivanovo
Country [168] 0 0
Russian Federation
State/province [168] 0 0
Kazan
Country [169] 0 0
Russian Federation
State/province [169] 0 0
Moscow
Country [170] 0 0
Russian Federation
State/province [170] 0 0
Saint-Petersburg
Country [171] 0 0
Serbia
State/province [171] 0 0
Belgrade
Country [172] 0 0
Serbia
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Sremska Kamenica
Country [173] 0 0
Singapore
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Singapore
Country [174] 0 0
Slovenia
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Ljubljana
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Spain
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Guipuzcoa
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Spain
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Barcelona
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Spain
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Cordoba
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Spain
State/province [178] 0 0
Madrid
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Spain
State/province [179] 0 0
Malaga
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Spain
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Valencia
Country [181] 0 0
Sweden
State/province [181] 0 0
Malmö
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Taichung
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Thailand
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Turkey
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Turkey
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Ukraine
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Dnipropetrovsk
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Kyiv
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Sheffield
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United Kingdom
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This multicenter, randomized, double-blind study will evaluate the efficacy, safety, and
pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with
placebo in combination with nab-paclitaxel in participants with locally advanced or
metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy
for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been
determined in previous studies of participants with mBC and the safety data to date suggest
that atezolizumab can be safely combined with standard chemotherapy agents.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries
Contact person responsible for updating information