A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Pl... | Not Recruiting
A Study of Atezolizumab in Combinat... | Not Recruiting
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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Medical Conditions
  • Triple Negative Breast Cancer
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Not Recruiting
Trial source and source ID number
NCT02425891
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody, Drug : Nab-Paclitaxel, Drug : Placebo

Study Arm Groups : Atezolizumab Plus Nab-Paclitaxel, Atezolizumab Plus Nab-Paclitaxel, Placebo Plus Nab-Paclitaxel, Placebo Plus Nab-Paclitaxel

Intervention Type
See Interventions above
Primary Outcome Measures
    Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in all Randomized Participants; 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); 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; Baseline until death due to any cause (up to 53 months); OS in Participants with Detectable PD-L1; Baseline until death due to any cause (up to 53 months)
Secondary Outcome Measures
    Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in all Randomized Participants; 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; 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; 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; 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; 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; 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); Baseline up to 53 months; Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab; 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; Pre-dose (Hour 0) on Cycle 1 Day 1 up to 53 months (detailed timeframe is provided in outcome description section); Minimum Serum Concentration (Cmin) for Atezolizumab; Pre-dose (Hour 0) on Cycle 1 Day 1 up to 53 months (detailed timeframe is provided in outcome description section); Plasma Concentrations of Total Paclitaxel; 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)
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
900
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Rosemere Cancer Centre at Royal Preston Hospital
Fulwood
England
PR2 9HT
Royal Marsden - Surrey
Sutton
England
SM2 5PT
Edinburgh Cancer Centre at Western General Hospital
Edinburgh
Scotland
EH4 2XU
Velindre Cancer Center at Velindre Hospital
Cardiff
Wales
CF14 2TL
London
EC1A 7BE
Plymouth
PL6 8DH
Guy's Hospital
London
SE1 9RT
Royal Marsden Hospital - Sutton
London
England
SW3 6JJ
Sheffield
S10 2SJ
M2O 4BX
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, Colombia, Costa Rica, Czechia, Denmark, 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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
WO29522
Sponsor(s)
Hoffmann-La Roche
Key Dates

Recruitment Start Date

Jun 2015

Recruitment End Date

Apr 2020

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

21 Apr 2015

Date updated in source

01 Aug 2017