A Study of Pertuzumab With High-Dose Trastuzumab for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (MBC) With Central Nervous System (CNS) Progression Post-Radiotherapy

Completed · Phase 2

Conditions studied: Metastatic Breast Cancer

In brief

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.

Key facts

Study ID

NCT02536339

Run by

Genentech, Inc.

People needed

40

Starts

2015-12-16

Expected to finish

2020-12-29

Last updated by the study team

2021-12-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Cancer Center — Tucson, Arizona, United States
• City of Hope National Medical Center — Duarte, California, United States
• Stanford Cancer Institute — Stanford, California, United States
• University of Miami Hospital & Clinics — Miami, Florida, United States
• H. Lee Moffitt Cancer Center and Research Inst. — Tampa, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• University of Maryland Medical Center; Department of Neurology — Baltimore, Maryland, United States
• Associates in Oncology-Hematology, PC — Bethesda, Maryland, United States
• Dana Farber Cancer Inst. — Boston, Massachusetts, United States
• Allina Health System — Saint Paul, Minnesota, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• Mid Ohio Oncology Hematology;ZangMeister Center (West) — Columbus, Ohio, United States
• Temple Cancer Center; Oncology — Philadelphia, Pennsylvania, United States
• Methodist Hospital Research Institute — Houston, Texas, United States
• Huntsman Cancer Institute; University of Utah — Salt Lake City, Utah, United States
• Northwest Medical Specialties, PLLC — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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