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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
Cancer Breast Cancer Metastatic Breast Cancer
Basic Details
Sponsor
Genentech, Inc.
Phase
Phase 2
Trial Identifier
NCT02536339, ML29366
Condition
Metastatic Breast Cancer
Official Title
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)
Study Summary
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.
Eligibility Criteria
All
≥18 Years
No
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
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com