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

• Status: Completed
• Trial end date: 2020-12-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Pertuzumab; Trastuzumab

Criteria

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