Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

Clinical trial: Radiation Therapy in Treating Women With Early Stage Breast Cancer

Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. Giving it after surgery may kill any tumor cells that remain after surgery.
  PURPOSE: This phase II trial is studying the side effects of radiation therapy and to see how well it works in treating women with early stage breast cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To determine the freedom from local and regional failure in women with early stage breast cancer treated with accelerated, hypofractionated radiotherapy.
  -  To determine the acute and late toxicity of accelerated, hypofractionated radiotherapy using previously published toxicity scales.
  Secondary
  -  To measure cosmesis using the Harvard cosmesis scale in patients who have undergone lumpectomy.
  -  To identify co-variates responsible for poor cosmetic outcome in these patients.
  OUTLINE: Patients who have undergone lumpectomy undergo either intracavitary balloon brachytherapy boost and hypofractionated, accelerated whole breast irradiation (AWBI) OR 3D-conformal radiotherapy (3D-CRT)/intensity-modulated radiotherapy (IMRT) boost and AWBI. Patients who have undergone mastectomy undergo hypofractionated, accelerated chest wall irradiation.
  -  Intracavitary balloon brachytherapy boost and AWBI (post-lumpectomy): Patients undergo intracavitary balloon brachytherapy boost twice daily for 2 days (total of 4 fractions). Beginning 5-21 days after completion of brachytherapy, patients undergo AWBI once daily 5 days a week for approximately 2 weeks (total of 11 fractions).
  -  3D-CRT/IMRT boost and AWBI (post-lumpectomy): Patients undergo 3D-CRT/IMRT boost twice daily for 2 days (total of 4 fractions). Patients also undergo AWBI as above before or after boost radiotherapy.
  -  Accelerated chest wall irradiation (post-mastectomy): Patients undergo accelerated chest wall irradiation once daily 5 days a week for approximately 2 weeks (total of 11 fractions).
  Patients who have undergone lumpectomy undergo frontal digital photography of the breasts at baseline, immediately before the initiation of radiotherapy, and then annually for 3 years after completion of radiotherapy. These patients also complete the Breast Cancer Treatment Outcome Scale at baseline and at 3 years after completion of radiotherapy. Physicians complete the Harvard Cosmesis scale at baseline and at 1 and 3 years after completion of radiotherapy.
  After completion of study treatment, patients are followed up at weeks 1, 4, and 8 and then every 4 months for 2 years, every 6 months for 3 years, and annually thereafter.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed breast cancer, including 1 of the following subtypes:
  -  Ductal carcinoma in situ
  -  Invasive ductal carcinoma
  -  Invasive lobular carcinoma
  -  Medullary carcinoma
  -  Papillary carcinoma
  -  Colloidal (mucinous) carcinoma
  -  Tubular carcinoma
  -  Pathological stage 0-IIIA disease (pTis; pT1-2, N0-N2a, M0)
  -  Tumor size ≤ 5 cm
  -  Breast considered technically satisfactory for radiotherapy
  -  Has undergone lumpectomy or mastectomy and either sentinel node biopsy or axillary dissection (if invasive carcinoma is present)
  -  Negative inked histological margins (i.e., no invasive cells at surgical margin) or confirmed negative re-excision specimen
  -  Unifocal or multifocal (confined to 1 quadrant; tumors < 4 cm apart) disease with 1 or 2 foci that can be encompassed by 1 lumpectomy
  -  No proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by ≥ 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy
  -  No evidence of suspicious microcalcifications in the breast before the start of radiotherapy
  -  If malignancy-associated microcalcifications were initially present, the post-excision mammography must be negative
  -  No more than 9 positive axillary lymph nodes
  -  No palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless there is histologic confirmation that these nodes are negative for tumor
  -  No previously treated contralateral breast cancer or synchronous ipsilateral breast cancer
  -  No lobular carcinoma in situ alone (i.e., no invasive component) or non-epithelial breast malignancies (e.g., sarcoma or lymphoma)
  -  No Paget disease of the nipple
  -  No skin involvement, regardless of tumor size
  -  No distant metastases
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Pre- or post-menopausal
  -  ECOG performance status 0-1
  -  No co-existing medical condition that would limit life expectancy to < 2 years
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  No other malignancy within the past 5 years except for nonmelanoma skin cancer (the disease-free interval from any prior malignancy must be continuous)
  -  No collagen vascular disease, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
  -  No psychiatric or addictive disorder that would preclude obtaining informed consent
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  No prior radiotherapy for the current breast cancer
  -  No tylectomies so extensive that the cosmetic result is low or poor prior to radiotherapy
  -  Chemotherapy allowed provided the following criteria are met:
  -  Chemotherapy is not administered prior to, during, and for ≥ 21 days after completion of radiotherapy (for patients receiving brachytherapy boost)
  -  Chemotherapy is not administered for ≥ 21 days before, during, and for ≥ 21 days after completion of radiotherapy (for patients receiving external beam radiotherapy boost or chest wall irradiation)
  -  Concurrent tamoxifen, anastrozole, or other hormonal therapy allowed
  -  May be initiated before, during, or after radiotherapy
  -  No other concurrent chemotherapy, immunotherapy, or experimental medications

Relevance to patient case: not relevant