A Phase II Study to Evaluate the Efficacy and Safety Using Combined Monoclonal Antibodies, Trastuzumab and Pertuzumab in Subjects With Her-2 Overexpressed Locally Advanced and Metastatic Breast Cancer
- Determine the objective response rate in patients with HER2/neu-overexpressing,
inoperable locally advanced or metastatic breast cancer refractory to trastuzumab
(Herceptin®)-based therapy treated with trastuzumab and pertuzumab.
- Determine the safety and tolerability of this regimen in these patients.
- Determine the time to progression, progression-free survival, duration of response, and
the percentage of patients free from disease progression at 3, 6, and 12 months.
- Correlate pre-treatment HER-2/neu phosphorylation and the phosphorylation of downstream
markers of signaling pathways using tumor tissue and blood with pertuzumab sensitivity
and/or trastuzumab resistance in these patients.
OUTLINE: This is an open-label study.
Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1 and pertuzumab IV
over 30-60 minutes on day 2 of course 1. Beginning in course 2 and for all subsequent
courses, patients receive both trastuzumab and pertuzumab on day 1. Courses repeat every 21
days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Chia Portera, MD
NCI - Medical Oncology Branch
United States: Food and Drug Administration
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Bethesda, Maryland 20892-1182|