This clinical trial studies intensity-modulated accelerated partial breast irradiation (APBI) in treating older patients with estrogen receptor positive or negative and progesterone receptor positive stage 0-I breast cancer before surgery. APBI is a specialized type of radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02186470.
PRIMARY OBJECTIVES:
I. Establish the feasibility for preoperative APBI delivered with intensity-modulated radiation therapy (IMRT) in the prone position using daily computed tomography (CT) guidance for stage 0-I breast cancer patients who are intended to undergo a lumpectomy for breast conserving therapy.
SECONDARY OBJECTIVES:
I. To determine the acute and late surgical and radiation toxicity of preoperative APBI delivered with IMRT in the prone position.
II. To document the cosmetic appearance of the breast when treated with preoperative APBI IMRT in the prone position.
III. Establish the percentage of patients that can meet dosimetric goals and normal tissue constraints if treated with preoperative APBI IMRT in the prone position.
IV. Evaluate molecular changes in breast cancer and/or stroma before and after preoperative APBI.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT I: Patients undergo MRI and CT for treatment planning.
COHORT II: Patients undergo image-guided intensity-modulated APBI twice daily (BID) for 5 days over a period of 5-10 days for a total of 10 fractions. Within 4-6 weeks post-APBI, patients undergo lumpectomy.
After completion of treatment, patients are followed up at 4 weeks and then at 1, 2, and 3 years.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorSasha Jasmine Beyer