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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02425891
Recruitment Status : Active, not recruiting
First Posted : April 24, 2015
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE April 21, 2015
First Posted Date  ICMJE April 24, 2015
Last Update Posted Date February 18, 2020
Actual Study Start Date  ICMJE June 23, 2015
Estimated Primary Completion Date April 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2017)
  • 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 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) ]
  • PFS According to RECIST v1.1 in Participants with Detectable Programmed Death-Ligand 1 (PD-L1) [ Time Frame: 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) ]
  • Overall Survival (OS) in all Randomized Participants [ Time Frame: Baseline until death due to any cause (up to 53 months) ]
  • OS in Participants with Detectable PD-L1 [ Time Frame: Baseline until death due to any cause (up to 53 months) ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 21, 2015)
Progression Free Survival (PFS), defined as the time from randomization to the time of radiographic progression or death from any cause during the study for both the Intent To Treat (ITT) population and the PD-L1-positive subpopulations [ Time Frame: Approximately 22 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2017)
  • 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 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) ]
  • 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 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) ]
  • Duration of Response (DOR) According to RECIST v1.1 in all Randomized Participants [ Time Frame: 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) ]
  • DOR Acccording to RECIST v1.1 in Participants with Detectable PD-L1 [ Time Frame: 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) ]
  • 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 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) ]
  • 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 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) ]
  • Percentage of Participants with Adverse Events (AEs) or Serious AEs (SAEs) [ Time Frame: Baseline up to 53 months ]
  • Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab [ Time Frame: 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) ]
  • Maximum Serum Concentration (Cmax) for Atezolizumab [ Time Frame: Pre-dose (Hour 0) on Cycle 1 Day 1 up to 53 months (detailed timeframe is provided in outcome description section) ]
    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)
  • Minimum Serum Concentration (Cmin) for Atezolizumab [ Time Frame: Pre-dose (Hour 0) on Cycle 1 Day 1 up to 53 months (detailed timeframe is provided in outcome description section) ]
    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)
  • 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2015)
  • Overall Survival, defined as the time from the date of randomization to the date of death from any cause for both Intent to Treat population and PD-L1-positive subpopulation [ Time Frame: Approximately 3.6 years ]
  • Objective Response Rate for both Intent to Treat population and PD-L1-positive subpopulation [ Time Frame: Approximately 3.6 years ]
  • Duration of Objective Response (DOR) defined as time from first occurrence of a documented objective tumor response to time of radiographic progression (per investigator using RECIST v1.1) or death from any cause on study, whichever occurs first [ Time Frame: Approximately 3.6 years ]
  • Time to deterioration (TTD) in global health status/HRQoL, defined by a minimally important decrease of > or = 10 points on the global health status/HRQoL scale of the EORTC QLQ-C30 [ Time Frame: Approximately 3.6 years ]
  • Incidence, nature, and severity of adverse events graded according to NCI CTCAE v4.0 [ Time Frame: Approximately 3.6 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Triple Negative Breast Cancer
Intervention  ICMJE
  • 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 will be 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.
Study Arms  ICMJE
  • Experimental: Atezolizumab Plus Nab-Paclitaxel
    Participants assigned to atezolizumab plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.
    Interventions:
    • Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
    • Drug: Nab-Paclitaxel
  • Placebo Comparator: Placebo Plus Nab-Paclitaxel
    Participants assigned to placebo plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.
    Interventions:
    • Drug: Nab-Paclitaxel
    • Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 23, 2016)
900
Original Estimated Enrollment  ICMJE
 (submitted: April 21, 2015)
350
Estimated Study Completion Date  ICMJE April 14, 2020
Estimated Primary Completion Date April 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Bosnia and Herzegovina,   Brazil,   Canada,   Chile,   Colombia,   Costa Rica,   Czechia,   Estonia,   Finland,   France,   Germany,   Greece,   Guatemala,   Hong Kong,   Hungary,   Italy,   Japan,   Korea, Republic of,   Latvia,   Mexico,   Norway,   Panama,   Poland,   Romania,   Russian Federation,   Serbia,   Singapore,   Slovenia,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Denmark,   Portugal
 
Administrative Information
NCT Number  ICMJE NCT02425891
Other Study ID Numbers  ICMJE WO29522
2014-005490-37 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP