Prospective Randomised Clinical Trial Testing the Role of Prophylactic Cranial Radiotherapy in Patients Treated With Trastuzumab (Herceptin®) for Metastatic Breast Cancer
- To test if prophylactic cranial radiotherapy delivering 30 Gy in 10 fractions will
significantly reduce (from 35% to 21% at 2 years) the incidence of symptomatic brain
metastases in patients treated with trastuzumab (Herceptin®) for metastatic breast
OUTLINE: This is a multicenter study. Patients are stratified by center, type of systemic
therapy (trastuzumab [Herceptin®] monotherapy vs combination with chemotherapy), hormone
receptor status, and presence of lung metastases (yes vs no). Patients are randomized to 1
of 2 treatment arms.
- Arm I: Patients receive taxane/trastuzumab therapy for 6 weeks. While continuing
taxane/trastuzumab therapy, patients then undergo 10 fractions of concurrent
prophylactic cranial radiotherapy in the absence of disease progression or unacceptable
- Arm II: Patients receive taxane/trastuzumab therapy without concurrent prophylactic
All patients undergo quality of life assessments every 8 weeks for 9 months.
After completion of study treatment, patients are followed periodically for at least 1 year.
Allocation: Randomized, Primary Purpose: Prevention
Incidence of symptomatic brain metastases
Peter A. Canney, MD
University of Glasgow