Partial Breast Irradiation (PBI) for Selected Patients With Early Breast Cancer
Partial Breast Irradiation (PBI) for Selected Patients With Early Breast Cancer
This study investigates the feasibility and safety of delivering radiation therapy only to
 part of the breast, (the tumor bed and selected areas) rather than the whole breast, for
 patients with early stage breast cancer.
Inclusion Criteria

 1. Histologic Documentation:

 -  Patients will have histologically confirmed Unicentric Stage I (T1 N0 M0)
 invasive ductal breast cancer.

 -  Histologically negative tumor margin 2 mm or more from any inked edges, or no
 tumor in a re-excision specimen or final shaved specimen.

 -  Tubular, mucinous and medullary variant histologies of infiltrating ductal
 carcinoma are permitted.

 -  Low-grade DCIS (I and II) of 2 cm or less with histologically negative margins of
 at least 2 mm margins (or a negative re-excision) are permitted.

 -  Women age 70 years or older with T1 invasive ductal carcinoma which are
 estrogen-receptor positive (ER+) with clinically negative axillary nodes who do
 not undergo surgical lymph node evaluation are also eligible if patient will take
 hormonal therapy.

 -  Patients with T1N0 (i+) tumors on sentinel lymph node mapping or dissection (i.e.
 is tumor deposit is 0.2mm or less, regardless of whether the deposit is detected
 by IHC or H&E staining) will also be eligible, provided that completion axillary
 dissection has been performed to confirm N0 status.

 -  In the case where invasive cancer is present, the invasive cancer's pathology
 will be used regardless if DCIS is also present.

 2. Prior Treatment: Patient may have been treated with adjuvant chemotherapy. Patients
 may be on adjuvant hormonal therapy or begin hormonal therapy following XRT at the
 discretion of the medical oncologist.

 Radiation therapy should begin within:

 -  4-12 weeks from definitive surgical procedure

 -  2-6 weeks after chemotherapy, if chemotherapy given first

 -  Radiation cannot be delivered concurrently with chemotherapy.

 3. Age >= 18 years of age

 4. ECOG Performance Status 0-2.

 5. Signed Informed Consent

 Exclusion Criteria

 The following guidelines are to assist physicians in selecting patients for whom protocol
 therapy is safe and appropriate. Physicians should recognize that the following may
 seriously increase the risk to the patient entering this protocol. Patients who meet the
 following criteria should not be entered in this study:

 1a Multicentric IDC of the breast defined as discontiguous tumors separated by at least 5
 cm of uninvolved tissue; alternatively, discontiguous tumors that are clinically or
 mammographically within separate breast quadrants or subareolar central region.

 1. b Multifocal IDC of the breast, defined as discontiguous discrete foci of invasive
 carcinoma, separated by uninvolved intervening tissue, but within an overall span of
 5cm, or within the same breast quadrant or subareolar central region.

 2. Tumor > 2.0 cm, nodal involvement on H&E staining, or metastatic involvement

 3. Histological evidence of:

 1. Lymphovascular invasion: as defined by a tumor embolus present in an
 endothelial-lined space; cases with tumor emboli present in a space not lined by
 endothelial cells but otherwise very suspicious for an angiolymphatic space were
 also considered ineligible.

 2. EIC (Extensive Intraductal Component): defined as the presence of intraductal
 carcinoma both within the primary infiltrating ductal tumor (comprising at least
 25% of the tumor area) and intraductal carcinoma present clearly beyond the edges
 of the invasive tumor, or as a predominantly intraductal tumor with one or more
 areas of focal invasion 7, 55.

 3. Invasive Lobular Carcinoma

 4. Infiltrating carcinoma with mixed ductal and lobular features: cases with
 ambiguous or mixed histologic features that showed positive E-cadherin staining
 throughout the tumor by immunohistochemistry were classified as ductal type and
 considered eligible 56, 57.

 5. Infiltrating papillary carcinoma

 6. Margins: In-situ or invasive carcinoma present less than 2 mm from the inked
 resection margin.

 4. History of cosmetic or reconstructive breast surgery

 5. Psychiatric illness which would prevent the patient from giving informed consent.
 Medical condition such as uncontrolled infection (including HIV), uncontrolled
 diabetes mellitus or connective tissue diseases (lupus, systemic sclerosis or other
 collagen vascular diseases) which, in the opinion of the treating physician, would
 make this protocol unreasonably hazardous for the patient.

 6. Patients with a "currently active" second malignancy other than non-melanoma skin
 cancers. Patients are not considered to have a "currently active" malignancy if they
 have completed therapy and considered by their physician to be at less than 5% risk of
 relapse within three years.

 7. Patients with diffuse (> 1 quadrant or > 5cm) suspicious microcalcifications

 8. Women who are pregnant.