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Protocol No.1594GCCPrincipal InvestigatorTkaczuk, Kate
PhasePhase II (Cancer Control)
Age GroupAdult
TitleAN 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)
DescriptionThis 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.

Please see www.clinicaltrials.gov for more information.
Reference ClinicalTrials.gov Identifier: NCT02536339

Or copy and paste the following link into your web browser:
https://www.clinicaltrials.gov/ct2/show/NCT02536339?term=NCT02536339&rank=1
TreatmentDrug: Pertuzumab Participants will receive an 840-mg loading dose of pertuzumab, followed every 3 weeks thereafter by a dose of 420 mg via IV infusion until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. •Drug: Trastuzumab Participants will receive trastuzumab at a dose of 6 mg/kg once weekly via IV infusion until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Key EligibilityInclusion Criteria:
•Adults at least 18 years of age
•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
•Left ventricular ejection fraction (LVEF) at least 50%
•Adequate hematologic, renal, and hepatic function
•Life expectancy more than 12 weeks
Applicable Disease SitesBreast - Female
Breast - Male
Therapies InvolvedHormonal Therapy
Immunotherapy
Drugs InvolvedHerceptin (Trastuzumab)
Pertuzumab
StatusOpen
Treatment TypeTreatment
ClinicalTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT02536339
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