Pertuzumab With High-Dose Trastuzumab in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (MBC) With Central Nervous System (CNS) Progression Post-Radiotherapy

  • Breast Cancer
Trial Status:

Completed

This trial runs in
Cities
  • Baltimore
  • Bethesda
  • Boston
  • Chicago
  • Duarte
  • Houston
  • Miami
  • Philadelphia
  • Saint Paul
  • Salt Lake City
  • Stanford
  • Stony Brook
  • Tacoma
  • Tampa
  • Tucson
Trial Identifier:

NCT02536339 ML29366

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial Summary

      This study will examine the safety and efficacy of pertuzumab in combination with high-dose trastuzumab in adult participants with HER2-positive MBC with CNS metastases and disease progression in the brain following radiotherapy.

      Genentech, Inc. Sponsor
      Phase 2 Phase
      NCT02536339 , ML29366 Trial Identifier
      Pertuzumab, Trastuzumab Treatments
      Metastatic Breast Cancer Condition
      Official Title

      An Open-Label, Single-Arm, Phase II Study of Pertuzumab With High-Dose Trastuzumab for the Treatment of Central Nervous System Progression Post-Radiotherapy in Patients With HER2-Positive Metastatic Breast Cancer (PATRICIA)

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Pathologically confirmed HER2-positive MBC
      • Progression of or new brain metastases after completion of whole-brain radiotherapy or stereotactic radiosurgery
      • Completion of whole-brain radiotherapy or stereotactic radiosurgery more than 60 days prior to enrollment
      • Stable systemic disease
      • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
      • LVEF at least 50%
      • Adequate hematologic, renal, and hepatic function
      • Life expectancy more than 12 weeks
      Exclusion Criteria
      • Progression of systemic disease at Screening
      • Leptomeningeal disease
      • History of intolerance or hypersensitivity to study drug
      • Use of certain investigational therapies within 21 days prior to enrollment
      • Current anthracycline use
      • Unwillingness to discontinue ado-trastuzumab emtansine or lapatinib use
      • Active infection
      • Pregnant or lactating women
      • Significant history or risk of cardiac disease
      • Symptomatic intrinsic lung disease or lung involvement
      • History of other malignancy within the last 5 years

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