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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02425891
Registration number
NCT02425891
Ethics application status
Date submitted
21/04/2015
Date registered
24/04/2015
Date last updated
19/07/2022
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)
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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
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Secondary ID [1]
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2014-005490-37
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Secondary ID [2]
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WO29522
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Triple Negative Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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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 received both agents until disease progression or unacceptable toxicity.
Placebo Comparator: Placebo Plus Nab-Paclitaxel - Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
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 disease progression or unacceptable toxicity.
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 was 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 disease progression or unacceptable toxicity.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in All Randomized Participants
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Assessment method [1]
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PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first.
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Timepoint [1]
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Baseline up to approximately 34 months
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Primary outcome [2]
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PFS According to RECIST v1.1 in Participants With Detectable Programmed Death-Ligand 1 (PD-L1)
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Assessment method [2]
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PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first.
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Timepoint [2]
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Baseline up to approximately 34 months
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Primary outcome [3]
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Overall Survival (OS) in All Randomized Participants
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Assessment method [3]
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OS was defined as the time from the date of randomization to the date of death from any cause.
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Timepoint [3]
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Baseline until death due to any cause (up to approximately 58 months)
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Primary outcome [4]
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OS in Participants With Detectable PD-L1
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Assessment method [4]
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OS was defined as the time from the date of randomization to the date of death from any cause.
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Timepoint [4]
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Baseline until death due to any cause (up to approximately 58 months)
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Secondary outcome [1]
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Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in All Randomized Participants
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Assessment method [1]
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An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1.
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Timepoint [1]
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Baseline up to approximately 34 months
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Secondary outcome [2]
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Percentage of Participants With an Objective Response of CR or PR According to RECIST v1.1 in Participants With Detectable PD-L1
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Assessment method [2]
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An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1.
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Timepoint [2]
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Baseline up to approximately 34 months
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Secondary outcome [3]
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Duration of Response (DOR) According to RECIST v1.1 in All Randomized Participants
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Assessment method [3]
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DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause, whichever occurred first.
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Timepoint [3]
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Baseline up to approximately 34 months
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Secondary outcome [4]
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DOR Acccording to RECIST v1.1 in Participants With Detectable PD-L1
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Assessment method [4]
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DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause, whichever occurred first.
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Timepoint [4]
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Baseline up to approximately 34 months
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Secondary outcome [5]
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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
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Assessment method [5]
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Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participant's GHS/HRQoL scale score showed a >=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of >= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of >= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment.
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Timepoint [5]
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Baseline up to approximately 58 months
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Secondary outcome [6]
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TTD in Global Health Status/Health Related Quality of Life According to EORTC QLQ-C30 v3.0 in Participants With Detectable PD-L1
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Assessment method [6]
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Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participants's GHS/HRQoL scale score showed a >=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of >= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of >= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment.
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Timepoint [6]
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Baseline up to approximately 58 months
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Secondary outcome [7]
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Percentage of Participants With at Least One Adverse Event
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Assessment method [7]
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Percentage of participants with at least one adverse event.
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Timepoint [7]
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Baseline up to to the data cutoff date: 31 August 2021 (up to approximately 74 months)
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Secondary outcome [8]
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Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
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Assessment method [8]
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Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
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Timepoint [8]
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Baseline up to approximately 53 months
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Secondary outcome [9]
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Maximum Serum Concentration (Cmax) for Atezolizumab
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Assessment method [9]
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Maximum serum concentration for atezolizumab.
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Timepoint [9]
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Cycle 1 Day 1 (Cycle = 28 days)
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Secondary outcome [10]
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Minimum Serum Concentration (Cmin) for Atezolizumab
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Assessment method [10]
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Minimum serum concentration for atezolizumab.
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Timepoint [10]
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Day 27 of Cycle 1, 2, 3, and 7 (Cycle = 28 days)
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Secondary outcome [11]
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Plasma Concentrations of Total Paclitaxel
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Assessment method [11]
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Plasma Concentrations of Total Paclitaxel
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Timepoint [11]
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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)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/06/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/08/2021
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Sample size
Target
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Accrual to date
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Final
902
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Chris O'Brien Lifehouse - Camperdown
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Recruitment hospital [2]
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Nepean Cancer Care Centre - Sydney
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Recruitment hospital [3]
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Icon Cancer Foundation - South Brisbane
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Recruitment hospital [4]
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Princess Alexandra Hospital; Division of Cancer Services - Woolloongabba
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Recruitment hospital [5]
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Peninsula and South Eastern Haematology and Oncology Group - Frankston
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Recruitment hospital [6]
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Peter MacCallum Cancer Centre; Medical Oncology - Melbourne
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Recruitment hospital [7]
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Sunshine Hospital - St Albans
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Recruitment hospital [8]
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St John of God Hospital; Bendat Cancer Centre - Subiaco
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2747 - Sydney
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Recruitment postcode(s) [3]
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4101 - South Brisbane
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Recruitment postcode(s) [4]
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4102 - Woolloongabba
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Recruitment postcode(s) [5]
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3199 - Frankston
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Recruitment postcode(s) [6]
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3000 - Melbourne
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Recruitment postcode(s) [7]
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3021 - St Albans
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Recruitment postcode(s) [8]
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6008 - Subiaco
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Recruitment outside Australia
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GO
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Greece
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State/province [90]
0
0
Athens
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Country [91]
0
0
Greece
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State/province [91]
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0
Heraklion
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Country [92]
0
0
Greece
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State/province [92]
0
0
Patras
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Country [93]
0
0
Greece
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State/province [93]
0
0
Thessaloniki
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Country [94]
0
0
Guatemala
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State/province [94]
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0
Guatemala City
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Country [95]
0
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Hong Kong
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State/province [95]
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Hong Kong
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Country [96]
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Hungary
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State/province [96]
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Budapest
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Country [97]
0
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Hungary
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State/province [97]
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Szeged
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Country [98]
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Italy
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State/province [98]
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Campania
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Country [99]
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Italy
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State/province [99]
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Lombardia
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Country [100]
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Japan
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State/province [100]
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0
Aichi
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Country [101]
0
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Japan
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State/province [101]
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0
Fukushima
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Country [102]
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Japan
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State/province [102]
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Gunma
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Country [103]
0
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Japan
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State/province [103]
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0
Hiroshima
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Country [104]
0
0
Japan
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State/province [104]
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0
Hokkaido
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Country [105]
0
0
Japan
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State/province [105]
0
0
Hyogo
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Country [106]
0
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Japan
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State/province [106]
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0
Kagoshima
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Country [107]
0
0
Japan
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State/province [107]
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0
Kanagawa
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Country [108]
0
0
Japan
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State/province [108]
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0
Kumamoto
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Country [109]
0
0
Japan
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State/province [109]
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Kyoto
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Country [110]
0
0
Japan
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State/province [110]
0
0
Mie
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Country [111]
0
0
Japan
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State/province [111]
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0
Miyagi
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Country [112]
0
0
Japan
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State/province [112]
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0
Niigata
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Country [113]
0
0
Japan
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State/province [113]
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0
Okayama
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Country [114]
0
0
Japan
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State/province [114]
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0
Okinawa
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Country [115]
0
0
Japan
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State/province [115]
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Osaka
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Country [116]
0
0
Japan
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State/province [116]
0
0
Saitama
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Country [117]
0
0
Japan
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State/province [117]
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0
Shizuoka
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Country [118]
0
0
Japan
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State/province [118]
0
0
Tokyo
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Country [119]
0
0
Korea, Republic of
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State/province [119]
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0
Goyang-si
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Country [120]
0
0
Korea, Republic of
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State/province [120]
0
0
Seoul
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Country [121]
0
0
Latvia
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State/province [121]
0
0
Daugavpils
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Country [122]
0
0
Latvia
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State/province [122]
0
0
Riga
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Country [123]
0
0
Mexico
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State/province [123]
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0
Mexico CITY (federal District)
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Country [124]
0
0
Mexico
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State/province [124]
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0
Nuevo LEON
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Country [125]
0
0
Mexico
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State/province [125]
0
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Colima
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Country [126]
0
0
Mexico
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State/province [126]
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0
D.f.
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Country [127]
0
0
Mexico
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State/province [127]
0
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Mexico City
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Country [128]
0
0
Norway
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State/province [128]
0
0
Bergen
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Country [129]
0
0
Norway
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State/province [129]
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0
Kristiansand
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Country [130]
0
0
Norway
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State/province [130]
0
0
Stavanger
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Country [131]
0
0
Panama
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State/province [131]
0
0
Panama
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Country [132]
0
0
Poland
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State/province [132]
0
0
Bydgoszcz
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Country [133]
0
0
Poland
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State/province [133]
0
0
Gdynia
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Country [134]
0
0
Poland
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State/province [134]
0
0
Kraków
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Country [135]
0
0
Poland
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State/province [135]
0
0
Lublin
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Country [136]
0
0
Poland
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State/province [136]
0
0
Warszawa
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Country [137]
0
0
Romania
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State/province [137]
0
0
Timisoara
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Country [138]
0
0
Russian Federation
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State/province [138]
0
0
Arhangelsk
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Country [139]
0
0
Russian Federation
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State/province [139]
0
0
Moskovskaja Oblast
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Country [140]
0
0
Russian Federation
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State/province [140]
0
0
Ivanovo
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Country [141]
0
0
Russian Federation
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State/province [141]
0
0
Kazan
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Country [142]
0
0
Russian Federation
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State/province [142]
0
0
Saint-Petersburg
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Country [143]
0
0
Singapore
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State/province [143]
0
0
Singapore
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Country [144]
0
0
Slovenia
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State/province [144]
0
0
Ljubljana
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Country [145]
0
0
Spain
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State/province [145]
0
0
Cordoba
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Country [146]
0
0
Spain
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State/province [146]
0
0
Barcelona
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Country [147]
0
0
Spain
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State/province [147]
0
0
Madrid
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Country [148]
0
0
Spain
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State/province [148]
0
0
Malaga
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Country [149]
0
0
Spain
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State/province [149]
0
0
Valencia
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Country [150]
0
0
Sweden
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State/province [150]
0
0
Stockholm
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Country [151]
0
0
Sweden
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State/province [151]
0
0
Uppsala
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Country [152]
0
0
Switzerland
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State/province [152]
0
0
Basel
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Country [153]
0
0
Switzerland
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State/province [153]
0
0
St. Gallen
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Country [154]
0
0
Switzerland
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State/province [154]
0
0
Zürich
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Country [155]
0
0
Taiwan
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State/province [155]
0
0
Kaohsiung
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Country [156]
0
0
Taiwan
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State/province [156]
0
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Taichung
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Country [157]
0
0
Taiwan
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State/province [157]
0
0
Taipei
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Country [158]
0
0
Thailand
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State/province [158]
0
0
Bangkok
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Country [159]
0
0
Thailand
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State/province [159]
0
0
Songkhla
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Country [160]
0
0
Turkey
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State/province [160]
0
0
Adana
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Country [161]
0
0
Turkey
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State/province [161]
0
0
Istanbul
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Country [162]
0
0
Turkey
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State/province [162]
0
0
Izmir
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Country [163]
0
0
Turkey
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State/province [163]
0
0
Sihhiye/Ankara
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Country [164]
0
0
Ukraine
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State/province [164]
0
0
Dnipropetrovsk
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Country [165]
0
0
Ukraine
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State/province [165]
0
0
Kyiv
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Country [166]
0
0
Ukraine
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State/province [166]
0
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Lutsk
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Country [167]
0
0
Ukraine
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State/province [167]
0
0
Lviv
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Country [168]
0
0
United Kingdom
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State/province [168]
0
0
Cardiff
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Country [169]
0
0
United Kingdom
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State/province [169]
0
0
Edinburgh
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Country [170]
0
0
United Kingdom
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State/province [170]
0
0
London
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Country [171]
0
0
United Kingdom
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State/province [171]
0
0
Manchester
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Country [172]
0
0
United Kingdom
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State/province [172]
0
0
Plymouth
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Country [173]
0
0
United Kingdom
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State/province [173]
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0
Preston
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Country [174]
0
0
United Kingdom
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State/province [174]
0
0
Sheffield
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Country [175]
0
0
United Kingdom
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State/province [175]
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This multicenter, randomized, double-blind study evaluated 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02425891
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Public notes
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Contacts
Principal investigator
Name
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0
Clinical Trials
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Address
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Hoffmann-La Roche
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Phone
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02425891
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