Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer

    Cancer Categories
    • Breast
    Karmanos Trial ID
    • NRG-BR004
    NCT ID
    • NCT03199885
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase III
    Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug
    • Phase III
    Principal Investigator

    Objective:

    Primary Objective
    • To determine whether the addition of atezolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will improve the progression-free survival (PFS), assessed by investigator using RECIST 1.1 criteria, relative to a regimen of paclitaxel, pertuzumab, trastuzumab, and placebo in patients with newly documented HER2-positive measurable metastatic breast cancer.
    Secondary Objectives
    • To determine whether the addition of atezolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will improve the overall survival (OS) relative to a regimen of paclitaxel, pertuzumab, trastuzumab, and placebo.
    • To determine whether the addition of atezolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will improve the overall objective response (OR), assessed by investigator using RECIST 1.1 criteria, relative to a regimen of paclitaxel, pertuzumab, trastuzumab, and placebo.
    • To determine whether the addition of atezolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will improve PFS, OR, and/or duration of objective response assessed by retrospective blinded central review using RECIST 1.1 criteria, relative to a regimen of paclitaxel, pertuzumab, trastuzumab, and placebo.
    • To determine whether the addition of atezolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will decrease the incidence of subsequent brain metastases in patients without known brain metastases at study entry relative to a regimen of paclitaxel, pertuzumab, trastuzumab, and placebo.
    • To determine whether the addition of atezolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will contribute to increased patient-reported fatigue in comparison to a regimen of paclitaxel, pertuzumab, trastuzumab, and placebo.
    • To determine the utility of PD-L1 IHC staining as a predictive and prognostic biomarker associated with clinical response, as assessed by investigator using RECIST 1.1 criteria, to atezolizumab in combination with paclitaxel, trastuzumab, and pertuzumab.
    • To determine the immune-related toxicity profile of the two treatment regimens.
    • To determine the cardiac safety profile of the two treatment regimens.
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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    Phone: 800-527-6266

    Karmanos Cancer Institute at Lawrence and Idell Weisberg Cancer Treatment Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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    Phone: 800-527-6266

    Karmanos Cancer Institute at McLaren Bay Region

    3140 W Campus Dr.
    Bay City, MI 48706
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    Phone: 989-667-2370

    Karmanos Cancer Institute at McLaren Central Michigan, Morey Cancer Center

    1221 South Drive
    Mt Pleasant, MI 48858
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    Phone: 989-772-6811

    Karmanos Cancer Institute at McLaren Clarkston

    5680 Bow Pointe Dr
    Clarkston, MI 48346
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    Phone: 248-922-6650

    Karmanos Cancer Institute at McLaren Flint

    4100 Beecher Rd
    Flint, MI 48532
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    Phone: 810-342-3800

    Karmanos Cancer Institute at McLaren Flint - Singh and Arora

    4100 Beecher Road
    Flint, MI 48532
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    Karmanos Cancer Institute at McLaren Greater Lansing

    1540 Lake Lansing Rd.
    Lansing, MI 48912
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    Phone: 517-913-3890

    Karmanos Cancer Institute at McLaren Greater Lansing - Lake Lansing Road

    1540 Lake Lansing Rd.
    Lansing, MI 48912
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    Phone: 517-913-3890

    Karmanos Cancer Institute at McLaren Lapeer Region

    1295 Barry Drive
    Lapeer, MI 48446
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    Phone: 800-527-6266

    Karmanos Cancer Institute at McLaren Macomb

    1080 Harrington Blvd
    Mount Clemens, MI 48043
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    Phone: 586-493-7500

    Karmanos Cancer Institute at McLaren Northern Michigan, Petoskey

    560 W Mitchell St
    Petoskey, MI 49770
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    Phone: 231-487-3390

    Karmanos Cancer Institute at McLaren Port Huron

    1221 Pine Grove Ave
    Port Huron, MI 48060
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    Phone: 810-982-5200