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

Clinical trial: Breast-Conserving Surgery Followed by Radiation Therapy With MRI-Detected Stage I or Stage II Breast Cancer

Summary: RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.
  PURPOSE: This phase II clinical trial is studying how well breast-conserving surgery followed by radiation therapy works in treating patients with stage I or stage II breast cancer.

Detailed description: PRIMARY OBJECTIVES:
  I. To determine ipsilateral breast tumor recurrence rates as well as tumor bed recurrence rates. Patients will be followed for a period of five years following completion of radiation to determine these rates.
  II. To determine the cosmetic outcome resulting from breast conserving surgery and breast radiation.
  SECONDARY OBJECTIVES:
  I. To determine if there are patient factors which limit a patient's suitability to receive breast conserving therapy in the setting of multi-centric disease.
  II. To determine patient satisfaction of breast conserving therapy as it pertains to their overall treatment experience as measured by a questionnaire.
  III. To evaluate wound healing and overall complication rate after radiation as a component of breast conserving therapy.
  OUTLINE:
  Patients undergo breast-conserving surgery consisting of partial mastectomies followed by external beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.
  After completion of study treatment, patients are followed at 1 month, then every 3 months for 1 year, every 6 months for 1 year, and then annually for 5 years.

Eligibility: Inclusion
  -  Patients with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm)
  -  All radiographically suspicious lesions must be biopsied and have histologically confirmed ductal carcinoma in-situ, invasive ductal, invasive lobular, medullary, papillary, colloid (mucinous), or tubular histologies
  -  A maximum of two radiographically detected malignant lesions
  -  Clinical Stage I-II breast carcinoma, with lesion size =< 5 cm for the dominant mass and the second lesion detected only on MRI, treated with lumpectomies; the MRI detected lesion must be pathologically =< 1 cm
  -  Axillary lymph node evaluation, either sentinel lymph node biopsy or axillary dissection as deemed appropriate by the treating surgeon for all patients with invasive cancer; no axillary lymph node sampling is needed for patients with DCIS
  -  Negative resection margins with at least a 2 mm margin from invasive and in-situ cancer or a negative re-excision
  -  A posterior margin =< 2 mm from DCIS is permissible provided fascia was taken
  -  Patients are eligible regardless of estrogen receptor, progesterone receptor, or Her-2/neu amplification
  -  Hormonal therapy is allowed; if adjuvant chemotherapy is planned, the chemotherapy should be delivered first and radiation must begin no earlier than three weeks and no later than eight weeks following completion of chemotherapy
  -  Signed study-specific informed consent prior to study entry
  Exclusion
  -  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)
  -  Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically confirmed negative
  -  Patients receiving neoadjuvant chemotherapy
  -  Patients with distant metastatic disease detected by radiographic imaging; specific studies for systemic imaging should be obtained as directed by localized symptoms or per available NCCN guidelines
  -  Patients with known BRCA 1/BRCA 2 mutations or those with predicted risk of carrying the mutation by BRCAPRO (44) risk assessment >= 50%
  -  Diffuse calcifications throughout the breast
  -  Patients with skin involvement or inflammatory breast cancer
  -  Patients with Paget's disease of the nipple
  -  Patients nonepithelial breast malignancies such as lymphoma or sarcoma
  -  Patients with collagen vascular disorders, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis
  -  Patients with psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent
  -  Other malignancy, except non-melanomatous skin cancer, < 5 years prior to participation in this study
  -  Patients who are pregnant or lactating, due to potential fetal exposure to radiation and unknown effects of radiation on lactating females

Relevance to patient case: not relevant