Phase I/II Study of TLC D-99 Plus Herceptin as First or Second Line Therapy for Patients With Locally Advanced Inflammatory or Metastatic Breast Cancer
- Determine the safety, especially the cardiac safety, of doxorubicin HCl liposome and
trastuzumab (Herceptin) as first- or second-line therapy in women with metastatic,
inflammatory, or locally advanced breast cancer.
OUTLINE: Patients are stratified according to prior anthracycline therapy (yes vs no).
Patients receive doxorubicin HCl liposome IV over 1 hour followed 30 minutes later by
trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15. Treatment continues
every 21 days in the absence of unacceptable toxicity or disease progression.
Patients are followed for at least 3 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Primary Purpose: Treatment
Maria Theodoulou, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|