Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery
Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation
 therapy after surgery kill any remaining tumor cells and may be an effective treatment for
 breast cancer.

 PURPOSE: This phase II trial is studying how well radiation therapy works in treating women
 with locally recurrent breast cancer previously treated with repeat breast-conserving
 surgery.
OBJECTIVES:

 Primary

 -  To evaluate skin, breast, and chest wall adverse events occurring within 1 year after
 completion of 3D-conformal partial-breast re-irradiation following repeat
 breast-preserving surgery in patients with locally recurrent breast carcinoma.

 Secondary

 -  To evaluate the adverse events occurring after 1 year from the completion of
 re-irradiation and at any time.

 -  To evaluate in-breast control rate in patients treated with this regimen.

 -  To evaluate freedom-from-mastectomy rate in these patients.

 -  To evaluate the rate of circulating tumor cells (CTCs) in this patient population and to
 document eradication of CTCs by locoregional therapy.

 -  To determine whether translational objective will correlate with eradication or presence
 of CTCs with in-breast recurrence and distant metastasis-free survival.

 -  To evaluate cosmesis as judged by the patient and independent evaluation.

 -  To evaluate distant metastasis-free survival, mastectomy-free survival, and overall
 survival of patients treated with this regimen.

 OUTLINE: This is a multicenter study.

 Patients undergo 3-dimensional conformal accelerated partial-breast irradiation twice daily,
 5 days a week, for 3 weeks.

 Some patients undergo blood sample collection at baseline and within 3 weeks after completion
 of radiotherapy for circulating tumor cells analysis.

 Some patients complete questionnaires on cosmesis at baseline and at 1 and 3 years following
 radiotherapy.

 After completion of study therapy, patients are followed up periodically for 4-5 years and
 then every year thereafter.
DISEASE CHARACTERISTICS:

 -  Histologically confirmed locally recurrent breast carcinoma consistent with the
 following cell types:

 -  Invasive ductal breast carcinoma

 -  Medullary ductal breast carcinoma

 -  Tubular ductal breast carcinoma

 -  Mucinous ductal breast carcinoma

 -  Lobular breast carcinoma

 -  Ductal carcinoma in situ (DCIS)

 -  No Paget disease of the nipple

 -  Target lumpectomy cavity must be clearly defined and the target lumpectomy
 cavity/ whole-breast reference volume must be < 30% based on a post-operative,
 pre-treatment CT scan

 -  Tumor size ≤ 3 cm in greatest dimension on pathologic specimen

 -  Negative histologic margins of resection and no tumor on ink following
 breast-preserving surgery of local recurrence (Re-excision is permitted to
 achieve negative margins)

 -  Axilla negative or ≤ 3 positive lymph nodes without extracapsular extension

 -  If the in-breast recurrence is DCIS and/or microinvasive disease, a sentinel
 lymph node (SLN) evaluation is not required, but if performed:

 -  Patients with a negative sentinal lymph node (SLN) biopsy are eligible for
 enrollment

 -  Patients with a positive SLN biopsy require an axillary lymph node (ALN)
 dissection (ALND is not required if the SLN is not identified)

 -  Patient is eligible if 0-3 positive ALNs without extracapsular extension is
 documented

 -  If the in-breast recurrence is invasive disease and:

 -  No prior ALN dissection or SLN dissection only:

 -  Patient is required to undergo axillary evaluation with either a SLN or ALN
 dissection

 -  If the SLN is not identified or if the SLN is positive for metastatic
 disease then an ALN dissection is required

 -  Patient is eligible for enrollment if encounter 0-3 positive lymph nodes
 without extracapsular extension

 -  • Prior ALN dissection: negative clinical exam: patient is eligible for
 enrollment

 -  It is recommended, but not required, that the patient undergo ultrasound
 evaluation of the axilla and the lymph node draining regions of the breast;
 any suspicious areas are to be biopsied and if positive followed with an ALN
 dissection

 -  Patient is eligible for enrollment if biopsies are negative or 0-3 axillary
 lymph nodes without extracapsular extension are encountered

 -  Prior ALN dissection: positive clinical exam: biopsy required

 -  If biopsy is negative, patient is eligible for enrollment

 -  If biopsy is positive an ALN dissection is required

 -  Patient is eligible for enrollment if biopsies are negative or 0-3 axillary
 lymph nodes without extracapsular extension encountered

 -  Ipsilateral breast mammogram and MRI within 120 days prior to study entry

 -  Contralateral breast mammogram within 12 months of study entry

 -  For invasive in-breast recurrence, no more than 120 days since whole-body (positron
 emission tomography) PET-CT scan OR CT scan of the chest, abdomen, and pelvis, and
 bone scan

 -  No multicentric ipsilateral breast recurrence or regional recurrence (other than
 axilla)

 -  Patients must have a breast technically amenable to partial-breast irradiation

 -  No metastatic disease documented by physical exam or radiographic evaluation (for
 patients with invasive disease)

 -  No skin involvement

 -  No prior contralateral mastectomy

 -  Estrogen and progesterone status must be known

 PATIENT CHARACTERISTICS:

 -  Zubrod performance status 0-1

 -  Menopausal status not specified

 -  Not pregnant or nursing

 -  Negative pregnancy test

 -  Fertile patients must use effective contraception

 -  No other invasive malignancy within the past 3 years except ipsilateral breast cancer
 and/or nonmelanoma skin cancer

 -  No collagenous diseases, specifically systemic lupus erythematosus, scleroderma, or
 dermatomyositis

 -  No psychiatric or addictive disorders that would preclude obtaining informed consent

 PRIOR CONCURRENT THERAPY:

 -  See Disease Characteristics

 -  More than 2 weeks since prior chemotherapy and recovered

 -  No concurrent intensity-modulated radiotherapy

 -  No concurrent chemotherapeutic agents, including trastuzumab