Clinical TrialsThe James Cancer Center Columbus, OH
open for enrollment
Intensity Modulated Accelerated Partial Breast Irradiation in Treating Older Patients with Hormone Responsive Stage 0-I Breast Cancer before Surgery
Feasibility Of Assessing Radiation Response With MRI/CT Directed Preoperative Accelerated Partial Breast Irradiation In The Prone Position For Hormone Responsive Early Stage Breast Cancer.
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.
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.
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.
Are you eligible?
The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines
Patient must be > 18 years
The patient must have clinical node negative, stage I breast cancer
The surgical treatment must be intended to be a lumpectomy
The biopsy site must have been demarcated by a clip(s)
Gross disease must be unifocal on mammogram (mammo)/magnetic resonance imaging (MRI) imaging
Patient must be able to tolerate lying in the prone position with arms extended forward
Must be able to tolerate MRI scan with contrast
COHORT II: The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines
COHORT II: Patient must be >= 60 years
COHORT II: Core biopsy demonstrating breast cancer and receptors that are estrogen receptor (ER) or progesterone receptor (PR) positive
COHORT II: Core tissue must have human epidermal growth factor receptor 2 (HER 2) testing
COHORT II: The patient must have clinical node negative, stage I breast cancer
COHORT II: The surgical treatment must be intended to be a lumpectomy
COHORT II: The biopsy site must have been demarcated by a clip(s)
COHORT II: Gross disease must be unifocal on Mammo/ MRI imaging
COHORT II: Patients must have estrogen receptor (ER) and progesterone receptor (PR) analysis performed on core biopsy
COHORT II: Patient must be able to tolerate lying in the prone position with arms extended forward
COHORT II: Must be able to tolerate MRI scan with contrast
COHORT II: At the time of enrollment, patients must have had bilateral mammograms within 6 months
COHORT II: Patients must be willing to undergo breast cancer surgery minimally 4, maximally 6 weeks post APBI
COHORT II: Patients with a history of non-breast malignancies are eligible if they have been disease free for 5 or more years prior to enrollment and are deemed by their physicians to be at low risk for recurrence; patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin
Age < 60 years
Hormone unresponsive breast cancer
T-2 (> 3.0 cm), T-3, stage III, or stage IV breast cancer
N-1, N-2, or N-3 pathologic axillary nodes
Unwilling to undergo anti-endocrine therapy
Suspicious microcalcification, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign
Non-epithelial breast malignancies such as sarcoma or lymphoma
Paget’s disease of the nipple
Proven multicentric carcinoma (invasive or ductal carcinoma in situ [DCIS]) in more than one quadrant or separated by > 4 centimeters
Any prior treatment with radiation therapy, chemotherapy, biotherapy, or hormone therapy for the currently diagnosed breast cancer prior to study enrollment
Prior breast or thoracic radiation therapy (RT) for any condition
Psychiatric of addictive disorders or other condition that in the opinion of the investigator would preclude the patient from meeting the study requirements