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
NCT ID: NCT02536339
Last Updated: 2021-12-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2015-12-16
2020-12-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pertuzumab + Trastuzumab
Participants with CNS metastases secondary to HER2-positive MBC will receive pertuzumab in combination with high-dose trastuzumab until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Pertuzumab
Participants will receive 840 milligrams (mg) loading dose of pertuzumab, followed every 3 weeks thereafter by a dose of 420 mg via intravenous (IV) infusion until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Trastuzumab
Participants will receive trastuzumab at a dose of 6 milligrams per kilogram (mg/kg) of body weight once weekly via IV infusion until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Interventions
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Pertuzumab
Participants will receive 840 milligrams (mg) loading dose of pertuzumab, followed every 3 weeks thereafter by a dose of 420 mg via intravenous (IV) infusion until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Trastuzumab
Participants will receive trastuzumab at a dose of 6 milligrams per kilogram (mg/kg) of body weight once weekly via IV infusion until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Countries
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References
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Lin NU, Pegram M, Sahebjam S, Ibrahim N, Fung A, Cheng A, Nicholas A, Kirschbrown W, Kumthekar P. Pertuzumab Plus High-Dose Trastuzumab in Patients With Progressive Brain Metastases and HER2-Positive Metastatic Breast Cancer: Primary Analysis of a Phase II Study. J Clin Oncol. 2021 Aug 20;39(24):2667-2675. doi: 10.1200/JCO.20.02822. Epub 2021 May 4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ML29366
Identifier Type: -
Identifier Source: org_study_id