A Study of Pertuzumab Combined with High-Dose Trastuzumab for Patients who have Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer with Central Nervous System Progression After Radiation Therapy

Overview

About this study

This study will examine the safety and effectiveness of pertuzumab combined with high-dose trastuzumab in adult patients who have HER2-positive breast cancer that has spread to the central nervous system and the brain following radiation therapy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Adults at least 18 years of age
  • 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
  • Left ventricular ejection fraction (LVEF) at least 50%
  • Adequate hematologic, renal, and hepatic function
  • Life expectancy of 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Saranya Chumsri, M.D.

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20260176

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