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Clinical trialNCT03199885TerminatedPhase 3Interventional

Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer

SponsorNational Cancer Institute (NCI)Enrollment190Metastatic Breast AdenocarcinomaMetastatic HER2-Positive Breast CarcinomaRecurrent Breast AdenocarcinomaRecurrent HER2-Positive Breast CarcinomaStage III Breast Cancer AJCC v7Stage IV Breast Cancer AJCC v6 and v7+2 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This randomized phase III trial studies how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body (metastatic). Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab is a form of "targeted therapy" because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Monoclonal antibodies, such as pertuzumab, may interfere with the ability of cancer cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab may kill more tumor cells. \*NOTE: This study has a central confirmation step. The purpose of this step is to confirm by central testing that the patient's tumor has specific receptors. If the patient meets all the study requirements, the patient will join the study and begin therapy for breast cancer while the tumor is being tested.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

673 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada
  • Cross Cancer Institute

    Edmonton, Alberta, Canada

  • Bcca-Vancouver Cancer Centre

    Vancouver, British Columbia, Canada

  • Bcca-Vancouver Island Cancer Centre

    Victoria, British Columbia, Canada

  • the Moncton Hospital

    Moncton, New Brunswick, Canada

  • Doctor H. Bliss Murphy Cancer Centre

    St. John's, Newfoundland and Labrador, Canada

  • William Osler Health System-Brampton Civic Hospital

    Brampton, Ontario, Canada

  • London Regional Cancer Program

    London, Ontario, Canada

  • Algoma District Cancer Program Sault Area Hospital

    Sault Ste. Marie, Ontario, Canada

  • University Health Network-Princess Margaret Hospital

    Toronto, Ontario, Canada

  • Csss Champlain-Charles Le Moyne

    Greenfield Park, Quebec, Canada

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, Canada

United States
  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, United States

  • Katmai Oncology Group

    Anchorage, Alaska, United States

  • Banner Md Anderson Cancer Center

    Gilbert, Arizona, United States

  • Ctca at Western Regional Medical Center

    Goodyear, Arizona, United States

  • Banner-University Medical Center Phoenix

    Phoenix, Arizona, United States

  • Banner Boswell Medical Center

    Sun City, Arizona, United States

  • Nea Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

    Jonesboro, Arkansas, United States

  • Kaiser Permanente-Anaheim

    Anaheim, California, United States

  • Kaiser Permanente-Deer Valley Medical Center

    Antioch, California, United States

  • Kaiser Permanente-Baldwin Park

    Baldwin Park, California, United States

  • Kaiser Permanente-Bellflower

    Bellflower, California, United States

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, United States

  • Uc Irvine Health Cancer Center-Newport

    Costa Mesa, California, United States

  • City of Hope Comprehensive Cancer Center

    Duarte, California, United States

  • Kaiser Permanente Dublin

    Dublin, California, United States

  • Kaiser Permanente-Fontana

    Fontana, California, United States

  • Kaiser Permanente-Fremont

    Fremont, California, United States

  • Palo Alto Medical Foundation-Fremont

    Fremont, California, United States

  • Washington Hospital

    Fremont, California, United States

  • Kaiser Permanente-Fresno

    Fresno, California, United States

  • Kaiser Permanente - Harbor City

    Harbor City, California, United States

  • Kaiser Permanente-Irvine

    Irvine, California, United States

  • Loma Linda University Medical Center

    Loma Linda, California, United States

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, United States

  • Kaiser Permanente West Los Angeles

    Los Angeles, California, United States

  • Kaiser Permanente-Modesto

    Modesto, California, United States

  • Memorial Medical Center

    Modesto, California, United States

  • Palo Alto Medical Foundation-Camino Division

    Mountain View, California, United States

  • Kaiser Permanente-Oakland

    Oakland, California, United States

633 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
5 Apr 2019
Primary completion
30 Apr 2024
Completion
4 Apr 2025
Last update posted
29 May 2026
Registered enrollment
190
Registry id
NCT03199885

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.