Accelerated Partial Breast Radiation Therapy Using High-Dose Rate Brachytherapy in Treating Patients With Early Stage Breast Cancer After Surgery
Condition: Ductal Breast Carcinoma In Situ; Estrogen Receptor Positive; Invasive Breast Carcinoma; Progesterone Receptor Positive; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIA Breast Cancer
MeSH terms: Carcinoma; Breast Neoplasms; Carcinoma in Situ; Carcinoma, Ductal, Breast; Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating
Intervention: Accelerated Partial Breast Irradiation; High-Dose Rate Brachytherapy; Questionnaire Administration
Intervention description: Undergo accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy; Undergo APBI using HDR brachytherapy; Ancillary studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: Female
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well accelerated partial breast irradiation (APBI) using
      high-dose rate (HDR) brachytherapy works in treating patients with breast cancer that has not
      spread beyond the breast or the axillary lymph nodes (early-stage) after surgery. Radiation
      therapy uses a type of energy to kill cancer cells and shrink tumors. Brachytherapy is a type
      of internal radiation therapy that provides radiation inside the breast to any remaining
      tumor cells next to the space where the tumor was removed, and is given over a shorter amount
      of time than standard radiation therapy. Giving accelerated partial breast irradiation (APBI)
      using high-dose rate (HDR) brachytherapy may reduce the overall time that radiation is
      delivered to the tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must sign informed consent

          -  Surgical treatment of the breast must have been lumpectomy; the margins of the
             resected specimen must be histologically free of tumor (negative surgical margins per
             National Surgical Adjuvant Breast and Bowel Project [NSABP] criteria)

          -  On histologic examination, the tumor must be ductal carcinoma in situ (DCIS) and/or
             invasive breast carcinoma

          -  For patients with invasive breast cancer, an axillary staging procedure must be
             performed (either sentinel node biopsy [SNB] alone or axillary dissection [with a
             minimum of six axillary nodes removed], and the axillary node[s] must be
             pathologically negative); patients over 70 with estrogen receptor positive (ER+)
             tumors no greater than 2 cm do not require axillary evaluation, but MUST be clinically
             node negative on examination and all available imaging (clinical N0)

          -  The T stage must be Tis, T1, or T2; if T2, the tumor must be =< 3.0 cm in maximum
             diameter

          -  Estrogen receptor positive tumor and/or progesterone receptor positive tumor

        Exclusion Criteria:

          -  Pregnant or breast-feeding

          -  Active collagen-vascular disease

          -  Paget's disease of the breast

          -  Prior history of DCIS or invasive breast cancer

          -  Prior breast or thoracic radiation therapy (RT) for any condition

          -  Multicentric carcinoma (DCIS or invasive)

          -  Synchronous bilateral invasive or non-invasive breast cancer

          -  Surgical margins that cannot be microscopically assessed or that are positive

          -  Positive axillary node(s)

          -  T stage of T2 with the tumor > 3 cm in maximum diameter or a T stage >= 3

          -  Estrogen receptor negative and progesterone receptor negative tumor

          -  Any of the dosimetric treatment criteria as defined have not been met; patients who
             become ineligible due to inability to meet dosimetric criteria should not receive
             treatment as defined in this protocol and will come off the study; any subsequent
             adjuvant radiation will be delivered at the discretion of the treating physician