Clinical Trials

The James Cancer Center Columbus, OH

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Intensity Modulated Accelerated Partial Breast Irradiation in Treating Older Patients with Hormone Responsive Stage 0-I Breast Cancer before Surgery

Protocol: OSU-13282

Full Title

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.

Purpose

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 Objective

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.

Are you eligible?

Inclusion Criteria:

COHORT I:

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

Exclusion Criteria:

COHORT II:

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

Mastectomy intended

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

Breast Cancer