Patient case: 70-year-old female with breast cancer; genetic feature: AURKA amplification

Clinical trial: Radiation Therapy in Treating Patients With Recurrent Breast Cancer

Summary: RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. It is not yet known whether a single dose of radiation therapy is more effective than implant radiation therapy for 5 days in treating patients with recurrent breast cancer.
  PURPOSE: This phase II trial is studying implant radiation therapy to see how well it works compared with radiation therapy during surgery in treating patients with recurrent breast cancer.

Detailed description: OBJECTIVES:
  -  To determine the in breast recurrence rate following repeat radiation to the breast. These patients will be followed for a period of five years following completion of radiation to determine these rates.
  -  To determine the cosmetic outcome resulting from partial breast re-irradiation using different techniques, including both physician and patient rated scales.
  -  To determine patient satisfaction of partial breast re-irradiation as it pertains to their overall treatment experience, as measured by a questionnaire.
  -  To determine if there are patient factors illuminated during a discussion of informed consent, which limit a patient's suitability to receive partial breast re-irradiation delivered by a particular technique.
  -  To evaluate tylectomy wound healing and overall complication rate after partial breast re-irradiation.
  -  To determine ipsilateral breast tumor recurrence rates and tumor bed recurrence rates.These patients will be followed for a period of five years following completion of the second course of radiation to determine these rates.
  OUTLINE: Patients are stratified according to which modality is best suited for the patient. Patients are assigned to 1 of 2 groups.
  All patients undergo excisional biopsy or needle localization removal of the tumor. Patients with margins < 2 mm undergo re-excision of the biopsy cavity.
  -  Group 1: Patients undergo partial breast irradiation delivered as a single intra-operative radiation dose to the tumor bed.
  -  Group 2: Patients undergo partial breast irradiation delivered by Mammosite® brachytherapy consisting of 10 fractions over 5 days.
  Quality of life is assessed at baseline, 1 month after completion of radiotherapy, and then at follow-up visits.
  After completion of study treatment, patients are followed up at 1 month, every 3 months for 1 year, and then every 6 months for 5 years.

Eligibility: Inclusion Criteria:
  -  Patients' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies.
  -  Lesion size ≤ 3 cm treated with a tylectomy and whole breast irradiation (with or without tumor bed boost)
  -  Unifocal breast cancer recurrence
  -  Negative resection margins with at least a 2 mm margin from invasive and in situ cancer or a negative re-excision
  -  Hormonal therapy is allowed. If chemotherapy is planned, the radiation is delivered first and chemotherapy must begin no earlier than two weeks following completion of radiation.
  -  Signed study-specific informed consent prior to study entry.
  Exclusion Criteria:
  -  Patients with distant metastatic disease
  -  Patients with invasive lobular carcinoma, extensive lobular carcinoma in-situ, extensive ductal carcinoma in-situ (spanning more than 3 cm), or nonepithelial breast malignancies such as lymphoma or sarcoma.
  -  Patients with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm). Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically or cytologically confirmed negative.
  -  Extensive intraductal component (EIC) by the Harvard definition, i.e. 1) more than 25% of the invasive tumor is DCIS and DCIS present in adjacent breast tissue. Presence of an EIC increases the chance of local recurrence, and as such, one might not be a candidate for repeat breast conservation.
  -  Patients with Paget's disease of the nipple.
  -  Patients with skin involvement.
  -  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.
  -  Patients with known BRCA 1/BRCA 2 mutations.

Relevance to patient case: not relevant