Patient case: 35-year-old female with Breast cancer. Genetic variant: NRAS Amplification. Other conditions: None.

Clinical trial: Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery

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.

Detailed description: 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 at 1 year and at any time of this regimen in these patients.
  -  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.

Eligibility: 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
  -  Initial lumpectomy followed by whole-breast radiotherapy performed over 1 year ago
  -  Repeat lumpectomy performed within the past 42 days
  -  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
  -  Histopathologic confirmation via lumpectomy of local in-breast ipsilateral recurrence within the past 120 days and the following must be true:
  -  Tumor size ≤ 3 cm in greatest dimension on pathologic specimen
  -  Negative histologic margins of resection and no tumor on ink following breast-preserving surgery
  -  Re-excision to achieve negative margins allowed
  -  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
  -  No more than 120 days since whole-body 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

Relevance to patient case: not relevant