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



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:December 16, 2015
End Date:March 30, 2020

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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)

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.


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
We found this trial at
19
sites
101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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22 South Greene Street
Baltimore, Maryland 21201
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6420 Rockledge Drive
Bethesda, Maryland 20817
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Boston, Massachusetts 02115
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303 East Superior Street
Chicago, Illinois 60611
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3100 Plaza Properties Boulevard
Columbus, Ohio 43213
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Hershey, PA
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Lake Success, New York 11042
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3401 North Broad Street
Philadelphia, Pennsylvania 19140
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Rochester, Minnesota 55905
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333 Smith Avenue North
Saint Paul, Minnesota 55102
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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Stanford, California 94305
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Tacoma, Washington 98405
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Tucson, Arizona
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