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

Clinical trial: Partial Breast Radiation Therapy in Treating Women Undergoing Breast-Conserving Therapy for Early Stage Breast Cancer

Summary: RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.
  PURPOSE: This clinical trial is studying how well partial breast radiation therapy works in treating women undergoing breast-conserving therapy for early stage breast cancer.

Detailed description: OBJECTIVES:
  -  To determine the cosmetic outcome resulting from partial breast irradiation using two different techniques.
  -  To determine patient satisfaction with partial breast irradiation as it pertains to their overall treatment experience as measured by a questionnaire.
  -  To determine if there are patient factors that limit a patient's suitability to receive partial breast irradiation delivered by a particular technique.
  -  To evaluate wound healing and overall complication rate after partial breast irradiation.
  -  To determine ipsilateral breast tumor recurrence rates and tumor bed recurrence rates.
  OUTLINE: Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days OR 3-dimensional conformal radiotherapy twice daily for 5-10 days.
  After completion of study therapy, patients are followed periodically for up to 5 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed breast cancer, including the following histologic subtypes:
  -  Invasive ductal carcinoma
  -  Medullary ductal carcinoma
  -  Papillary ductal carcinoma
  -  Colloid (mucinous) ductal carcinoma
  -  Tubular ductal carcinoma
  -  The following histologic subtypes are not allowed:
  -  Invasive lobular carcinoma
  -  Extensive lobular carcinoma in situ
  -  Ductal carcinoma in situ (DCIS)
  -  Nonepithelial breast malignancies, such as lymphoma or sarcoma
  -  No extensive intraductal component by Harvard definition (i.e., more than 25% of the invasive tumor is DCIS or DCIS present in adjacent tissue)
  -  Stage I or II disease (T1, N0; T1, N1a; T2, N0; or T2, N1a)
  -  Lesion ≤ 3 cm
  -  No more than 3 positive lymph nodes
  -  Patients with 4 or more positive axillary lymph nodes found at the time of axillary lymph node dissection/sentinel lymph node biopsy are not eligible
  -  Has undergone tylectomy (lumpectomy) and axillary lymph node sampling (axillary node dissection or sentinel node biopsy)
  -  Negative resection margins with ≥ 2 mm margin from invasive or in situ cancer OR a negative re-excision margin
  -  Unifocal breast cancer
  -  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 confirmed negative
  -  No skin involvement of disease
  -  No Paget's disease of the nipple
  -  No distant metastatic disease
  -  Hormone-receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Female
  -  Menopausal status not specified
  -  Not pregnant or lactating
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception for ≥ 1 week prior to, during, and for ≥ 2 weeks after completion of study treatment
  -  No collagen vascular disorders, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
  -  No psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent
  -  No other malignancy within the past 5 years, except non-melanomatous skin cancer
  PRIOR CONCURRENT THERAPY:
  -  No prior radiotherapy to the breast
  -  No chemotherapy for at least 2 weeks before and 2 weeks after completion of study radiotherapy
  -  Concurrent hormonal therapy allowed

Relevance to patient case: not relevant