Hypofractionated Radiation Therapy in Preventing Recurrence in Patients With Breast Cancer After Surgery
Condition: Stage I Breast Cancer AJCC v7; Stage IA Breast Cancer AJCC v7; Stage IB Breast Cancer AJCC v7; Stage II Breast Cancer AJCC v6 and v7; Stage IIA Breast Cancer AJCC v6 and v7; Stage IIB Breast Cancer AJCC v6 and v7; Stage IIIA Breast Cancer AJCC v7
MeSH terms: Breast Neoplasms
Intervention: Hypofractionated Radiation Therapy; Quality-of-Life Assessment; Radiation Therapy
Intervention description: Undergo hypofractionated radiation therapy; Ancillary studies; hypofractionated radiation therapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies how well hypofractionated radiation therapy works in
      preventing the return of tumor cells in breast cancer patients following surgery.
      Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter
      period of time and may kill more tumor cells and have fewer side effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological confirmation of breast cancer

          -  Pathologic stage T0-T3N0-N1M0

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2

          -  Able to and provides Institutional Review Board (IRB) approved study specific written
             informed consent

          -  Study entry must be within 12 weeks of last surgery (breast or axilla) or last
             chemotherapy (if applicable)

          -  Able to complete all mandatory tests

          -  Willing to return to enrolling institution for follow-up (during the active monitoring
             phase of the study)

          -  Fair, good or excellent cosmesis, as determined by trained nurse assessment using the
             Harvard Cosmetic Scale

          -  Radiotherapy must begin within 12 weeks of the last breast cancer surgery or the last
             dose of adjuvant chemotherapy

          -  Breast conserving surgery and indications for whole breast radiotherapy

        Exclusion Criteria:

          -  Medical contraindication to receipt of radiotherapy

          -  Severe active co-morbid systemic illnesses or other severe concurrent disease which,
             in the judgment of the investigator, would make the patient inappropriate for entry
             into this study or interfere significantly with the proper assessment of safety and
             toxicity of the prescribed regimens

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements or providing informed consent

          -  Active systemic lupus or scleroderma

          -  Pregnancy

          -  Prior receipt of ipsilateral breast or chest wall radiation

          -  Positive margins on ink after definitive surgery either for ductal carcinoma in situ
             (DCIS) or invasive cancer

          -  History of non-breast malignancies (except for in situ cancers treated only by local
             excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior
             study entry

          -  Recurrent breast cancer

          -  Indications for comprehensive regional nodal irradiation