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Clinical Trial of Atezolizumab With Paclitaxel, Trastuzumab, and Pertuzumab in Patients With Metastatic HER-2 Positive Breast Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 2025 to Dec 2026
    • Study completion date: Dec 2025 to Dec 2027
    v16
  2. Primary completion date: Jun 14, 2024 to Dec 2025
    • Study completion date: Dec 2024 to Dec 2025
    v15
  3. Primary completion date changed from estimate of Jun 2024 to Jun 14, 2024v14
  4. Primary completion date: Dec 2023 to Jun 2024v13
  5. Trial status: Suspended to Active, Not Recruiting
    • Primary completion date: Dec 2022 to Dec 2023
    • Enrollment target: estimated 50 to confirmed 16
    • Study completion date: Dec 2023 to Dec 2024
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Trial status: Recruiting to Suspended Sponsor's reason: adverse event risk and accrual challenges
    • Primary completion date: Jun 2022 to Dec 2022
    • Site details revised
    v11
  2. Primary completion date: Dec 2021 to Jun 2022v10
  3. Primary completion date: Dec 2020 to Dec 2021
    • Study completion date: Dec 2022 to Dec 2023
    v9
  4. Re-verified, no change to tracked fieldsv8
  5. Primary completion date: May 2019 to Dec 2020
    • Study completion date: May 2019 to Dec 2022
    v7
  6. Re-verified, no change to tracked fieldsv6
  7. Start date: Jun 6, 2017 to Jun 13, 2017v5
  8. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 2017 to Jun 6, 2017
    • Site details revised
    v4
  9. Start date: May 2017 to Jul 2017v3
  10. Start date: Apr 2017 to May 2017v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a single arm, Phase IIA clinical trial assessing the safety and efficacy of atezolizumab in combination with paclitaxel, trastuzumab, and pertuzumab in 50 patients with locally advanced, unresectable, or metastatic HER2-overexpressing breast cancer. Due to concerns that corticosteroids may have a negative effect on tumor immunity expected with addition of atezolizumab to the standard of care regimen, patients will receive premedication with dexamethasone only for weeks 1 and 2 of the weekly paclitaxel, and then corticosteroid premedication will be discontinued subsequently. Patients must have pathologically confirmed HER2-overexpressing breast cancer that is locally recurrent, unresectable, or metastatic, with measurable disease as defined by RECIST v1.1. Tumor measurements and bone scans will be performed every 9 weeks while patients are on study.
Trial Details
NCT Number NCT03125928
Lead Sponsor Fox Chase Cancer Center
Collaborators: Genentech, Inc.
Conditions
(from sponsor)		 HER2-positive Breast Cancer
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov