drugset / Trial / NCT00182793

Combination Chemotherapy With or Without Trastuzumab Followed By an Autologous Stem Cell Transplant and Radiation Therapy in Treating Patients With Stage III or Stage IV Breast Cancer

NCT00182793

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2005-07
Primary completion
2014-10
Completion
2014-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Trastuzumab Monoclonal antibody 6 mg/kg
Background Carboplatin Small molecule 800 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 6000 mg/m2 Intravenous
Background Melphalan Small molecule 150 mg/m2 Intravenous
Background Thiotepa Other / unclassified 500 mg/m2 Intravenous

Indications