A Phase II Study of the Feasibility and Efficacy of Breast Conserving Surgery in Patients With MRI Detected Multi-Centric Breast Cancer
PRIMARY OBJECTIVES:
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
radiation.
SECONDARY OBJECTIVES:
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.
OUTLINE:
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.
Interventional
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
No
William Chen, MD
Principal Investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Food and Drug Administration
CASE1109
NCT01100489
February 2010
October 2011
Name | Location |
---|---|
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 |