At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed stage IIIB or IIIC breast cancer with prior neoadjuvant or adjuvant therapy and prior surgery (lumpectomy or mastectomy)
- ✓Stage IV disease with 1-3 organ sites involved, ≤3 total lesions, and at least partial response to induction chemotherapy
- ✓Inflammatory breast cancer allowed
- ✓Age 65 or younger
- ✕Age over 65 years
- ✕Karnofsky performance status below 80%
- ✕Prior biologic therapy other than trastuzumab
- ✕Prior radiotherapy to adjacent or involved sites that would preclude study radiotherapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating trastuzumab, carboplatin, and 7 other interventions for Breast Cancer. Completed, enrolled 32 participants across 1 site.
Detailed Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, 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. An autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy with or without trastuzumab followed by an autologous stem cell transplant and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy with or without trastuzumab followed by an autologous stem cell transplant and radiation therapy works in treating patients with stage III or stage IV breast cancer.
Study Details
Timeline
Interventions
Cycle 1: 6 mg/kg on day -2 from PBSC reinfusion Cycle 2: 6 mg/kg on day -7 from PBSC reinfusion
Cycle 2: 800 mg/m2/96 hours on days -7 to -3 from PBSC reinfusion
Cycle 2: 6000 mg/m2/96 hours on days -7 to -3 from PBSC reinfusion
Cycle 1: 150 mg/m2 on day -1 from PBSC reinfusion
Cycle 2: 500 mg/m2/96 hours on days -7 to -3 from PBSC reinfusion
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.
Tandem high-dose chemotherapy comprising melphalan, carboplatin, thiotepa, and cyclophosphamide with or without trastuzumab (Herceptin®) followed by autologous peripheral blood stem cell transplantation.
Tandem high-dose chemotherapy comprising melphalan, carboplatin, thiotepa, and cyclophosphamide with or without trastuzumab (Herceptin®) followed by autologous peripheral blood stem cell transplantation
After recovery from high-dose chemotherapy and autologous PBSC transplantation; patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Treatment should be delivered daily M-F @ 180-200 cGY/day to a total of 4,500 to 5,040 cGy. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites. Treatment should be delivered daily @180-220 cGY/day to a total of 4,000-5,000 cGy.