Management of Metastatic Breast Cancer in Frail Patients
OBJECTIVES: I. Determine the safety and efficacy of gemcitabine in the treatment of elderly
women with metastatic breast cancer. II. Evaluate the quality of life in these patients.
OUTLINE: Patients receive gemcitabine IV over 1 hour weekly for 7 consecutive weeks in an 8
week course. Treatment then continues weekly for 3 consecutive weeks in 4 week courses in
the absence of disease progression or unacceptable toxicity. Quality of life is assessed
prior to treatment and then every 12 weeks. Patients are followed every 3 months for 2
years, then every 6 months until year 5, and then annually thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study over 2 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate (ORR)
Investigators planned to determine efficacy (objective response rate [ORR] by Response Evaluation Criteria In Solid Tumors [RECIST]).
Lodovico Balducci, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Federal Government