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

Clinical trial: Radiation Therapy in Treating Patients With Recurrent Breast Cancer

Summary: RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. It is not yet known whether a single dose of radiation therapy is more effective than implant radiation therapy for 5 days in treating patients with recurrent breast cancer.
  PURPOSE: This phase II trial is studying implant radiation therapy to see how well it works compared with radiation therapy during surgery in treating patients with recurrent breast cancer.

Detailed description: OBJECTIVES:
  -  To determine the in breast recurrence rate following repeat radiation to the breast with Mammosite® brachytherapy or intraoperative radiotherapy in patients with recurrent ipsilateral breast cancer.
  -  To determine the cosmetic outcome resulting from partial breast re-irradiation using different techniques, including both physician- and patient-rated scales.
  -  To determine patient satisfaction of partial breast re-irradiation as it pertains to their overall treatment experience, as measured by a questionnaire.
  -  To determine if there are patient factors which limit a patient's suitability to receive partial breast re-irradiation delivered by a particular technique.
  -  To evaluate tylectomy wound healing and overall complication rate after partial breast re-irradiation.
  -  To determine ipsilateral breast tumor recurrence rates and tumor bed recurrence rates.
  OUTLINE: Patients are stratified according to which modality is best suited for the patient. Patients are assigned to 1 of 2 groups.
  All patients undergo excisional biopsy or needle localization removal of the tumor. Patients with margins < 2 mm undergo re-excision of the biopsy cavity.
  -  Group 1: Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
  -  Group 2: Patients undergo partial breast irradiation delivered by Mammosite® brachytherapy consisting of 10 fractions over 5 days.
  Quality of life is assessed at baseline, 1 month after completion of radiotherapy, and then at follow-up visits.
  After completion of study treatment, patients are followed up at 1 month, every 3 months for 1 year, and then every 6 months for 5 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed ductal carcinoma in situ (DCIS) or invasive carcinoma of the breast (ductal, medullary, papillary, colloid [mucinous], or tubular) meeting the following criteria:
  -  Lesion size ≤ 3 cm treated with a tylectomy and whole breast irradiation (with or without tumor bed boost)
  -  Unifocal breast cancer recurrence
  -  Negative resection margins with ≥ a 2 mm margin from invasive and in situ cancer or a negative re-excision
  -  Patients with clinically and radiographically negative axillas should not undergo an axillary lymph node dissection unless they did not have prior axillary lymph node sampling (i.e., previous cancer was DCIS)
  -  No invasive lobular carcinoma, extensive lobular carcinoma in situ, extensive DCIS (≥ 3 cm), or nonepithelial breast malignancies such as lymphoma or sarcoma
  -  No multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by ≥ 4 cm)
  -  No palpable or radiographically suspicious contralateral axillary, ipsilateral, or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically or cytologically confirmed negative
  -  No extensive intraductal component by the Harvard definition, i.e., more than 25% of the invasive tumor is DCIS and DCIS present in adjacent breast tissue
  -  No distant metastatic disease
  -  No Paget's disease of the nipple
  -  No skin involvement
  -  No known BRCA1/BRCA2 mutations
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  -  No collagen vascular disorders, i.e., systemic lupus erythematosus, scleroderma, or dermatomyositis
  -  No psychiatric, neurologic, or addictive disorders that would preclude study participation
  -  No other malignancy within the past 5 years except nonmelanoma skin cancer
  -  Not pregnant or nursing
  -  Negative pregnancy test
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  At least 5 years since prior radiotherapy
  -  No chemotherapy within 2 weeks after completion of radiotherapy
  -  Concurrent hormonal therapy allowed

Relevance to patient case: not relevant