Node Negative, Invasive Breast Cancer Single Fraction IOERT
Node Negative, Invasive Breast Cancer Single Fraction IOERT
The purpose of this study is to determine if lumpectomy followed by Intraoperative Electron
 Radiation Therapy (IOeRT) as a single, full dose partial breast irradiation will have as good
 or better results in preventing recurrence of local breast cancer, cosmetic appearance and
 early and late side effects.
See points VIII inclusion/exclusion criteria

 Operation:

 -  Lumpectomy, steninal node biopsy

 -  IOeRT

 After Surgery:

 -  Meet with a medical oncologist and discuss if chemotherapy and/or hormone therapy is
 recommended as part of your treatment course. In some cases, pathology results may
 indicate the need for removal of additional lymph nodes. The doctor will review
 pathology and discuss if additional surgery is required.

 -  Chemotherapy (if indicated)

 -  Hormone therapy (if indicated)

 Follow-Up

 -  Visits will be completed with the surgeon, radiation oncologist and research staff as
 the protocol indicates.

 -  Assessements of acute toxicity according to CTC-toxicity scoring system

 -  Assessments of late toxicity according to LENT-SOMA scoring systems

 -  Assessment of cosmetic outcome according to scoring system and photo documentation in
 standardized positions.
Inclusion Criteria:

 -  Patient agrees to breast conservation therapy (segmental resection, partial
 mastectomy, and radiation therapy) as the treatment for their breast cancer

 -  Patient agrees to evaluation of the axilla with sentinel lymph node biopsy

 -  Post-menopausal women age > 60, defined as women who have experienced no menstrual
 period in the past 12 months.

 -  BRCA1 and 2 gene mutation negative, if tested. [genetic testing is NOT required based
 upon personal or family history]

 -  Unifocal (unicentric), invasive ductal carcinoma or favorable sub-types (mucinous,
 tubular, colloid) < 2.0 cm in diameter, primary T-stage of T1 (AJCC criteria)

 -  Grade 1, 2 acceptable

 -  Associated LCIS is allowed

 -  Estrogen receptor (ER) status of positive

 -  Negative margins at ink on gross pathologic examination

 -  Patient is node-negative, defined as N0 (i-) or N0 (i+)

 -  Patient must be deemed functionally and mentally competent to understand and sign the
 informed consent

 Exclusion Criteria:

 -  Prior breast malignancy or other malignancy if metastatic, or with expected survival
 of < 5 years

 -  Immuno-compromised status

 -  Pregnancy

 -  Women with an active connective tissue disorder (i.e. scleroderma, lupus and others)

 -  Breast cancer that involves the skin or chest wall, locally advanced breast cancer

 -  Pure DCIS, all grades

 -  Invasive lobular carcinoma

 -  Evidence of lymphovascular invasion (LVI)

 -  Invasive carcinoma with extensive intraductal component (EIC)

 -  Neoadjuvant chemotherapy indicated

 -  Patients with 1 or more positive lymph node determined during surgery with sentinel
 node and/or axillary dissection

 -  Not eligible for breast conserving management, i.e., prior whole breast radiation
 therapy

 -  Estrogen receptor negative

 -  Her2 positive

 -  Grade 3