Phase II Study of Tandem Cycle Dose-Intense Chemotherapy of Melphalan and Carboplatin, Thiotepa and Cyclophosphamide (STMP V) ± Trastuzumab Followed by Helical Tomotherapy or Local Regional Radiation Therapy for Stage IV Metastatic and Stage IIIB/C Breast Cancer
- Determine the feasibility of tandem high-dose chemotherapy comprising melphalan,
carboplatin, thiotepa, and cyclophosphamide with or without trastuzumab (Herceptin®)
followed by autologous peripheral blood stem cell transplantation and helical
tomotherapy or loco-regional radiotherapy in patients with high-risk stage IIIB, IIIC,
or IV breast cancer.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: Patients undergo stem cell collection.
- Course 1: Patients receive high-dose melphalan IV with or without trastuzumab
(Herceptin®). One day later, patients undergo autologous peripheral blood stem cell
(PBSC) transplantation. No more than 7 weeks later, patients proceed to course 2.
- Course 2: Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV
continuously over 4 days followed by autologous PBSC transplantation.
After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with
stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients
with stage IV disease undergo radiotherapy using helical tomotherapy or standard
radiotherapy to oligometastatic sites.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to relapse and/or progression
5 years post treatment
George Somlo, MD
City of Hope Medical Center
United States: Institutional Review Board
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|