A Phase II Study of the Feasibility and Efficacy of Breast Conserving Surgery in Patients With MRI Detected Multi-Centric Breast Cancer
I. To determine ipsilateral breast tumor recurrence rates as well as tumor bed recurrence
rates. Patients will be followed for a period of five years following completion of
radiation to determine these rates.
II. To determine the cosmetic outcome resulting from breast conserving surgery and breast
I. To determine if there are patient factors which limit a patient's suitability to receive
breast conserving therapy in the setting of multi-centric disease.
II. To determine patient satisfaction of breast conserving therapy as it pertains to their
overall treatment experience as measured by a questionnaire.
III. To evaluate wound healing and overall complication rate after radiation as a component
of breast conserving therapy.
Patients undergo breast-conserving surgery consisting of partial mastectomies followed by
external beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 1 month, then every 3 months
for 1 year, every 6 months for 1 year, and then annually for 5 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Ipsilateral breast tumor recurrence rates
Ipsilateral breast 6 months after diagnosis, bilateral annually for 5 years
5 years after completion of radiation
William Chen, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Food and Drug Administration
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|UH-Chagrin Highlands||Orange Village, Ohio 44122|
|UH-Westlake||Westlake, Ohio 44145|