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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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ClinicalTrials.gov Identifier: NCT02425891
Recruitment Status : Completed
First Posted : April 24, 2015
Results First Posted : May 17, 2021
Last Update Posted : July 19, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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.

Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody Drug: Nab-Paclitaxel Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 902 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : June 23, 2015
Actual Primary Completion Date : April 14, 2020
Actual Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Atezolizumab Plus Nab-Paclitaxel
Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
 Drug: 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.
Other Name: Tecentriq, MPDL3280A

Drug: 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.
Other Name: Abraxane®
Placebo Comparator: Placebo Plus Nab-Paclitaxel
Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
 Drug: 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.
Other Name: Abraxane®

Drug: Placebo
Placebo administered via IV infusion on Days 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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.

  2. PFS According to RECIST v1.1 in Participants With Detectable Programmed Death-Ligand 1 (PD-L1) [ Time Frame: Baseline up to approximately 34 months ]
    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.

  3. Overall Survival (OS) in All Randomized Participants [ Time Frame: Baseline until death due to any cause (up to approximately 58 months) ]
    OS was defined as the time from the date of randomization to the date of death from any cause.

  4. OS in Participants With Detectable PD-L1 [ Time Frame: Baseline until death due to any cause (up to approximately 58 months) ]
    OS was defined as the time from the date of randomization to the date of death from any cause.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.

  3. Duration of Response (DOR) According to RECIST v1.1 in All Randomized Participants [ Time Frame: Baseline up to approximately 34 months ]
    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.

  4. DOR Acccording to RECIST v1.1 in Participants With Detectable PD-L1 [ Time Frame: Baseline up to approximately 34 months ]
    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.

  5. 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 ]
    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.

  6. 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 ]
    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.

  7. 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) ]
    Percentage of participants with at least one adverse event.

  8. Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab [ Time Frame: Baseline up to approximately 53 months ]
    Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab

  9. Maximum Serum Concentration (Cmax) for Atezolizumab [ Time Frame: Cycle 1 Day 1 (Cycle = 28 days) ]
    Maximum serum concentration for atezolizumab.

  10. Minimum Serum Concentration (Cmin) for Atezolizumab [ Time Frame: Day 27 of Cycle 1, 2, 3, and 7 (Cycle = 28 days) ]
    Minimum serum concentration for atezolizumab.

  11. 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) ]
    Plasma Concentrations of Total Paclitaxel


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02425891


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:
Study Protocol  [PDF] January 31, 2020
Statistical Analysis Plan  [PDF] May 26, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02425891    
Other Study ID Numbers: WO29522
2014-005490-37 ( EudraCT Number )
First Posted: April 24, 2015    Key Record Dates
Results First Posted: May 17, 2021
Last Update Posted: July 19, 2022
Last Verified: June 2022
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Atezolizumab
Antibodies
Antibodies, Monoclonal
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Immune Checkpoint Inhibitors
Antineoplastic Agents, Immunological