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

Clinical trial: 3-Dimensional Conformal Radiation Therapy In Treating Women With Stage I or Stage II Breast Cancer Previously Treated With Lumpectomy and Axillary Node Dissection

Summary: RATIONALE: 3-dimensional conformal radiation therapy delivers a high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue.
  PURPOSE: Phase I/II trial to study the effectiveness of 3-dimensional conformal radiation therapy in treating women who have undergone lumpectomy and axillary node dissection for stage I or stage II breast cancer.

Detailed description: OBJECTIVES:
  -  Determine the technical feasibility and reproducibility of three-dimensional conformal radiotherapy confined to the region of the lumpectomy cavity in women with stage I or II breast cancer.
  -  Determine the cosmetic results in patients treated with this regimen.
  -  Determine the complication rates in patients treated with this regimen.
  -  Determine the local control rate in patients treated with this regimen.
  OUTLINE: This is a multicenter study.
  Patients undergo three-dimensional conformal radiotherapy twice daily for 5 days beginning within 8 weeks after surgery.
  Patients are followed at 6 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
  PROJECTED ACCRUAL: A total of 19-46 patients will be accrued for this study within 6.3 to 15.3 months.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed invasive breast cancer
  -  Stage I or II (T1, N0; T1, N1; T2, N0; or T2, N1)
  -  Unifocal disease (single focus that can be encompassed by one lumpectomy)
  -  The following histologies are eligible:
  -  Invasive ductal
  -  Medullary
  -  Papillary
  -  Colloid (mucinous)
  -  Tubular
  -  No invasive or extensive in situ lobular carcinoma or pure ductal carcinoma in situ (DCIS)
  -  No nonepithelial breast malignancies such as sarcoma or lymphoma
  -  Previously treated with lumpectomy of a lesion no greater than 3 cm and axillary dissection of at least 6 lymph nodes or a sentinel node biopsy
  -  Six surgical clips in place delineating the margins of the tylectomy cavity
  -  Negative, inked histologic margins of lumpectomy (greater than 2 mm) OR re-excision specimen available for confirmation
  -  Negative mammography post-lumpectomy or post-excision if malignancy-associated microcalcifications were initially present
  -  No prior lumpectomy so extensive that the cosmetic result is low or poor prior to radiotherapy
  -  No more than 3 positive axillary nodes
  -  No proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless negative by biopsy
  -  No palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless nodes are histologically negative
  -  No extensive intraductal carcinoma, indicated by one of the following according to the Harvard definition:
  -  More than 25 % of invasive tumor is DCIS and DCIS is in adjacent breast tissue
  -  Intraductal carcinoma with microinvasion
  -  No previously treated contralateral breast cancer or synchronous ipsilateral breast cancer
  -  No evidence of suspicious microcalcifications
  -  No Paget's disease of the nipple
  -  No skin involvement by disease, regardless of tumor size
  -  No distant metastases
  -  Hormone receptor status:
  -  Not specified
  PATIENT CHARACTERISTICS:
  Age
  -  18 and over
  Sex
  -  Female
  Menopausal status
  -  Not specified
  Performance status
  -  Not specified
  Life expectancy
  -  At least 2 years
  Hematopoietic
  -  Not specified
  Hepatic
  -  Not specified
  Renal
  -  Not specified
  Other
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  Technically suitable for breast radiotherapy
  -  No collagenous diseases (e.g., systemic lupus erythematosus, scleroderma, or dermatomyositis)
  -  No other medical condition that would limit life expectancy
  -  No psychiatric or addictive disorders that would preclude giving informed consent
  -  No other malignancy within the past 5 years except nonmelanoma skin cancer
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  At least 2 weeks since prior chemotherapy
  -  No concurrent chemotherapy during and for at least 2 weeks after completion of study therapy
  Endocrine therapy
  -  Concurrent anastrozole or tamoxifen allowed
  Radiotherapy
  -  No prior radiotherapy for the current malignancy
  Surgery
  -  See Disease Characteristics
  Other
  -  No prior nonhormonal therapy for the current malignancy

Relevance to patient case: not relevant