Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: 3D-Conformal External Beam
Intervention description: Radiation was to be delivered in 2 fractions per day, each of 1.5 Gy, separated by at least six hours, given in 15 consecutive working days to a total of 30 fractions and 45 Gy. Radiation was to be prescribed to the treatment unit isocenter, positioned at the approximate center of the planning target volume.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: Female
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: invasive ductal breast carcinoma; medullary ductal breast carcinoma with lymphocytic infiltrate; invasive lobular breast carcinoma; tubular ductal breast carcinoma; mucinous ductal breast carcinoma; ductal breast carcinoma in situ; lobular breast carcinoma in situ; recurrent breast cancer

Summary:

      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.
    

Eligibility criteria:

        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