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

Clinical trial: Radiation Therapy in Treating Post-Menopausal Women With Early Stage Breast Cancer Undergoing Surgery

Summary: This phase II trial studies how well radiation therapy works in treating post-menopausal women with early stage breast cancer undergoing surgery. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for breast cancer.

Detailed description: PRIMARY OBJECTIVE:
  I. For select patients with early stage breast cancer undergoing wide local excision followed by single fraction radiation therapy (SFRT), we will evaluate rates of observer-rated toxicity, cosmetic outcomes and patient satisfaction, objective measures of toxicity and quality of life as well as delivery of intended dose.
  SECONDARY OBJECTIVE:
  I. Locoregional control reported at five years.
  OUTLINE:
  Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.
  After completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and then every 6 months for 2 years.

Eligibility: Inclusion Criteria:
  -  Core needle biopsy (e.g. Mammotome, core, stereotactic, ultrasound guided) showing invasive mammary cancer (with or without concomitant ductal carcinoma or lobular carcinoma in situ) or ductal carcinoma in situ; acceptable histologic types of invasive mammary cancer include ductal, tubular, mucinous, papillary, cribriform and "NOS" (not otherwise specified); invasive lobular cancer is excluded
  -  Age >= 50 years and postmenopausal with no menses for at least one year prior to study enrollment
  -  Age > 70 years with invasive breast cancer clinical size =< 3 cm OR Age 50 - 70 years with invasive breast cancer clinical size =< 1.5 cm OR Age >= 50 years and postmenopausal with any grade ductal carcinoma in situ (DCIS) clinical extent =< 1.5 cm (clinical tumor size will be determined by pre-operative breast imaging-mammography, ultrasound and/or magnetic resonance imaging; in cases of multiple measurements, the largest recorded single dimension will be used to determine eligibility)
  -  Hormone receptor status
  -  Estrogen or progesterone receptor positive or
  -  Estrogen and progesterone receptor negative and clinical tumor size =< 1.0 cm
  -  Human epidermal growth factor receptor 2 (HER2)/neu negative on the core biopsy analysis defined as 0 or 1+ by immunohistochemistry or not amplified by fluorescent in situ hybridization analysis
  -  Tumor >= 0.5 cm from skin as defined by breast ultrasound
  -  Unicentric tumor
  -  Axillary lymph nodes negative by pre-operative physical examination in all cases and pathologic examination from surgery for invasive disease
  -  Negative surgical margins, defined as no margin-labeling ink on tumor cells from margin evaluation
  Exclusion Criteria:
  -  Initial core biopsy showing invasive lobular cancer
  -  Estrogen receptor and progesterone receptor negative tumor with clinical size > 1 cm
  -  Any Her 2+ breast cancer (immunohistochemistry 3+; or amplified by fluorescence in situ hybridization [FISH])
  -  Cancer in a patient with a known inherited susceptibility mutation in breast cancer (BRCA)1 or BRCA2
  -  Multicentric breast cancer (two foci of known cancer in the breast separated by greater than 5 cm, or in separate quadrants
  -  Clinically or pathologically positive axillary lymph nodes
  -  Any prior breast cancer
  -  Prior breast radiation therapy

Relevance to patient case: not relevant