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

Genentech

Status and phase: Completed; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: Trastuzumab; Drug: Pertuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02536339

ML29366

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Pertuzumab + Trastuzumab

Experimental group

Description:

Participants with CNS metastases secondary to HER2-positive MBC will receive pertuzumab in combination with high-dose trastuzumab until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

Treatment:

Drug: Pertuzumab

Drug: Trastuzumab