Trastuzumab and Pertuzumab in Treating Patients With Unresectable Locally Advanced or Metastatic Breast Cancer That Did Not Respond to Previous Trastuzumab
RATIONALE: Monoclonal antibodies, such as trastuzumab and pertuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving trastuzumab together with pertuzumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving trastuzumab together with pertuzumab works in treating patients with unresectable locally advanced or metastatic breast cancer that did not respond to previous trastuzumab.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Safety [ Designated as safety issue: Yes ]
- Minimal rate of clinical responses [ Designated as safety issue: No ]
- Time to progression [ Designated as safety issue: No ]
- Time to response [ Designated as safety issue: No ]
- Response duration [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
|Study Start Date:||December 2005|
|Study Completion Date:||October 2007|
- 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.
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||Chia Portera, MD||NCI - Medical Oncology Branch|