Skip to content
Triangle logo TriangleGet started
← Study library

NCT02425891 · CITED IN SOURCE DOCUMENTS

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)

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2022-07-19

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in All Randomized Participants

→

outcome · POSTED

PFS According to RECIST v1.1 in Participants With Detectable Programmed Death-Ligand 1 (PD-L1)

→

outcome · POSTED

Overall Survival (OS) in All Randomized Participants

→

outcome · POSTED

OS in Participants With Detectable PD-L1

→

outcome · POSTED

Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in All Randomized Participants

→

outcome · POSTED

Percentage of Participants With an Objective Response of CR or PR According to RECIST v1.1 in Participants With Detectable PD-L1

→

outcome · POSTED

Duration of Response (DOR) According to RECIST v1.1 in All Randomized Participants

→

outcome · POSTED

DOR Acccording to RECIST v1.1 in Participants With Detectable PD-L1

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

Percentage of Participants With at Least One Adverse Event

→

outcome · POSTED

Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab

→

outcome · POSTED

Maximum Serum Concentration (Cmax) for Atezolizumab

→

outcome · POSTED

Minimum Serum Concentration (Cmin) for Atezolizumab

→

outcome · POSTED

Plasma Concentrations of Total Paclitaxel

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
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 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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
    2. Drug: Nab-Paclitaxel
    label
    Atezolizumab Plus Nab-Paclitaxel
    type
    EXPERIMENTAL
  2. description
    Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: Nab-Paclitaxel
    2. Drug: Placebo
    label
    Placebo Plus Nab-Paclitaxel
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. Atezolizumab Plus Nab-Paclitaxel
    description
    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.
    name
    Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
    other Names
    1. Tecentriq, MPDL3280A
    type
    DRUG
  2. arm Group Labels
    1. Atezolizumab Plus Nab-Paclitaxel
    2. Placebo Plus Nab-Paclitaxel
    description
    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.
    name
    Nab-Paclitaxel
    other Names
    1. Abraxane®
    type
    DRUG
  3. arm Group Labels
    1. Placebo Plus Nab-Paclitaxel
    description
    Placebo administered via IV infusion on Days 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
    name
    Placebo
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
DOUBLE
who Masked
  1. PARTICIPANT
  2. INVESTIGATOR
primary Purpose
TREATMENT
Enrollment
count
902
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in All Randomized Participants
    time Frame
    Baseline up to approximately 34 months
  2. description
    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.
    measure
    PFS According to RECIST v1.1 in Participants With Detectable Programmed Death-Ligand 1 (PD-L1)
    time Frame
    Baseline up to approximately 34 months
  3. description
    OS was defined as the time from the date of randomization to the date of death from any cause.
    measure
    Overall Survival (OS) in All Randomized Participants
    time Frame
    Baseline until death due to any cause (up to approximately 58 months)
  4. description
    OS was defined as the time from the date of randomization to the date of death from any cause.
    measure
    OS in Participants With Detectable PD-L1
    time Frame
    Baseline until death due to any cause (up to approximately 58 months)
secondary Outcomes
  1. description
    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.
    measure
    Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in All Randomized Participants
    time Frame
    Baseline up to approximately 34 months
  2. description
    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.
    measure
    Percentage of Participants With an Objective Response of CR or PR According to RECIST v1.1 in Participants With Detectable PD-L1
    time Frame
    Baseline up to approximately 34 months
  3. description
    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.
    measure
    Duration of Response (DOR) According to RECIST v1.1 in All Randomized Participants
    time Frame
    Baseline up to approximately 34 months
  4. description
    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.
    measure
    DOR Acccording to RECIST v1.1 in Participants With Detectable PD-L1
    time Frame
    Baseline up to approximately 34 months
  5. description
    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.
    measure
    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
    time Frame
    Baseline up to approximately 58 months
  6. description
    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.
    measure
    TTD in Global Health Status/Health Related Quality of Life According to EORTC QLQ-C30 v3.0 in Participants With Detectable PD-L1
    time Frame
    Baseline up to approximately 58 months
  7. description
    Percentage of participants with at least one adverse event.
    measure
    Percentage of Participants With at Least One Adverse Event
    time Frame
    Baseline up to to the data cutoff date: 31 August 2021 (up to approximately 74 months)
  8. description
    Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
    measure
    Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
    time Frame
    Baseline up to approximately 53 months
  9. description
    Maximum serum concentration for atezolizumab.
    measure
    Maximum Serum Concentration (Cmax) for Atezolizumab
    time Frame
    Cycle 1 Day 1 (Cycle = 28 days)
  10. description
    Minimum serum concentration for atezolizumab.
    measure
    Minimum Serum Concentration (Cmin) for Atezolizumab
    time Frame
    Day 27 of Cycle 1, 2, 3, and 7 (Cycle = 28 days)
  11. description
    Plasma Concentrations of Total Paclitaxel
    measure
    Plasma Concentrations of Total Paclitaxel
    time Frame
    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)
Full study description
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.
Source references
references
  1. citation
    Li M, Yang B. Prognostic Value of NUSAP1 and Its Correlation with Immune Infiltrates in Human Breast Cancer. Crit Rev Eukaryot Gene Expr. 2022;32(3):45-60. doi: 10.1615/CritRevEukaryotGeneExpr.2021040248.
    pmid
    35695609
    type
    DERIVED
  2. citation
    Wang H, Ma H, Sove RJ, Emens LA, Popel AS. Quantitative systems pharmacology model predictions for efficacy of atezolizumab and nab-paclitaxel in triple-negative breast cancer. J Immunother Cancer. 2021 Feb;9(2):e002100. doi: 10.1136/jitc-2020-002100.
    pmid
    33579739
    type
    DERIVED
  3. citation
    Adams S, Dieras V, Barrios CH, Winer EP, Schneeweiss A, Iwata H, Loi S, Patel S, Henschel V, Chui SY, Rugo HS, Emens LA, Schmid P. Patient-reported outcomes from the phase III IMpassion130 trial of atezolizumab plus nab-paclitaxel in metastatic triple-negative breast cancer. Ann Oncol. 2020 May;31(5):582-589. doi: 10.1016/j.annonc.2020.02.003. Epub 2020 Feb 20.
    pmid
    32178964
    type
    DERIVED
  4. citation
    Schmid P, Rugo HS, Adams S, Schneeweiss A, Barrios CH, Iwata H, Dieras V, Henschel V, Molinero L, Chui SY, Maiya V, Husain A, Winer EP, Loi S, Emens LA; IMpassion130 Investigators. Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2020 Jan;21(1):44-59. doi: 10.1016/S1470-2045(19)30689-8. Epub 2019 Nov 27.
    pmid
    31786121
    type
    DERIVED
  5. citation
    Schmid P, Adams S, Rugo HS, Schneeweiss A, Barrios CH, Iwata H, Dieras V, Hegg R, Im SA, Shaw Wright G, Henschel V, Molinero L, Chui SY, Funke R, Husain A, Winer EP, Loi S, Emens LA; IMpassion130 Trial Investigators. Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer. N Engl J Med. 2018 Nov 29;379(22):2108-2121. doi: 10.1056/NEJMoa1809615. Epub 2018 Oct 20.
    pmid
    30345906
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-b46fbc223436da57887d
      requested nct id
      NCT02425891
      primary nct id
      NCT02425891
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source file sha256
      862f78faa9e4cbedc19f9ffcaeba97e029ba51b72bb3b81fc67aa8b6adf96904
      payload sha256
      50f9ae8f4413c730bfb234998564ed68bff3781ba8db69593e8b3c0f02ca4bea
      payload
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-b46fbc223436da57887d
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT02425891
      occurrences
      1. context exact
        HER2-negative hormone receptor&#8211;negative, advanced breast cancer was evaluated in the phase III, randomized, placebo-controlled <a href="/clinicaltrials/NCT02425891">IMpassion130</a> trial (NCT02425891).[<a href="#cit/section_10.58">58</a>,<a href="#cit/section_10.59">59</a>] Participants (N = 902) were randomly assigned
        end
        612509
        exact text
        NCT02425891
        start
        612498
      2. context exact
        1;negative, advanced breast cancer was evaluated in the phase III, randomized, placebo-controlled <a href="/clinicaltrials/NCT02425891">IMpassion130</a> trial (NCT02425891).[<a href="#cit/section_10.58">58</a>,<a href="#cit/section_10.59">59</a>] Participants (N = 902) were randomly assigned 1:1 to atezolizumab plus nanoparticle
        end
        612546
        exact text
        NCT02425891
        start
        612535
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/nci/raw/29bf1e5a1d739974ed.html
      source file sha256
      862f78faa9e4cbedc19f9ffcaeba97e029ba51b72bb3b81fc67aa8b6adf96904
      source json pointer
      Source null
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source retrieved at
      2026-09-09T23:21:35.419733+00:00
      source string basis
      UTF-8_text_with_universal_newline_translation
      source string sha256
      536430925e3b0008edd3fb69a869d5645bd6b6dc5c84c21ddf1b3e24f089874c
      source title
      Breast Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: April 25, 2025
        datetime
        2025-04-25T12:00:00Z
        display
        April 25, 2025

    Preserved source evidence · Not medical advice