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 |
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.
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
3100 Plaza Properties Boulevard
Columbus, Ohio 43213
Columbus, Ohio 43213
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22 South Greene Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
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1500 East Duarte Road
Duarte, California 91010
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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500 University Drive
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
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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Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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