Hypofractionated Radiation Therapy or Standard Radiation Therapy in Treating Patients With Ductal Breast Carcinoma In Situ or Early Invasive Breast Cancer
Condition: Ductal Breast Carcinoma In Situ; Invasive Breast Carcinoma; Stage I Breast Cancer AJCC v6; 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
MeSH terms: Carcinoma; Breast Neoplasms; Carcinoma in Situ; Carcinoma, Ductal, Breast; Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating
Intervention: External Beam Radiation Therapy; External Beam Radiation Therapy; Hypofractionated Radiation Therapy; Laboratory Biomarker Analysis; Quality-of-Life Assessment; Questionnaire Administration; Whole Breast Irradiation; Whole Breast Irradiation
Intervention description: Undergo HF-WBI; Undergo CF-WBI; Undergo HF-WBI; Optional correlative studies; Ancillary studies; Ancillary studies; Undergo HF-WBI; Undergo CF-WBI
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 301.0
Sex: Female
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies how well hypofractionated radiation therapy (RT) works
      compared to standard RT in treating patients with ductal breast carcinoma in situ (DCIS) or
      early invasive breast cancer. Radiation therapy (RT) uses high energy x-rays to kill tumor
      cells. Giving higher doses of RT over a shorter period of time may kill more tumor cells and
      have fewer side effects. It is not yet known if hypofractionated RT is more effective than
      standard RT in treating breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically confirmed ductal carcinoma in situ of the breast or early invasive
             breast cancer defined as pathologic stage Tis, T1, or T2, N0, N1mic, or N1a
             (pathologic staging of the axilla is required for all patients with invasive disease
             but is not required for patients with ductal carcinoma in situ [DCIS] only); (upfront
             pathologic stage cannot be assigned to patients treated with neoadjuvant chemotherapy;
             for such patients, the criteria for pathologic stage shall be applied to the initial
             clinical stage)

          -  Treatment with breast conserving surgery

          -  Final surgical margins must be negative, defined as no evidence for ductal carcinoma
             in situ or invasive breast cancer touching the inked surgical margin; if the invasive
             or in situ breast cancer approaches within less than 1 mm of the final surgical
             margin, then a reexcision is strongly encouraged; lobular carcinoma in situ at the
             final surgical margin will be disregarded

          -  Attending radiation oncologist declares intention to treat the whole breast only and
             that a third radiation field to treat regional lymph nodes is not planned (radiation
             of the undissected level I/II axilla with high tangents is allowed)

          -  If the patient has a history of a prior non-breast cancer, all treatment for this
             cancer must have been completed prior to study registration and the patient must have
             no evidence of disease for this prior non-breast cancer

          -  Patients must be enrolled on the trial within 12 weeks of the later of two dates: the
             final breast conserving surgical procedure or administration of the last cycle of
             concurrent cytotoxic chemotherapy

        Exclusion Criteria:

          -  Pathologic or clinical evidence for a stage T3 or T4 breast cancer

          -  Pathologic evidence for involvement of 4 or more axillary lymph nodes, or imaging
             evidence of involvement of infraclavicular, supraclavicular, or internal mammary lymph
             nodes

          -  Clinical or pathologic evidence for distant metastases

          -  Any prior diagnosis of invasive or ductal carcinoma in situ breast cancer in either
             breast

          -  Current diagnosis of bilateral breast cancer

          -  History of therapeutic irradiation to the breast, lower neck, mediastinum or other
             area in which there could potentially be overlap with the affected breast

          -  Patients not fluent in English or Spanish (The BCTOS will be available in these two
             languages)

          -  Patient is pregnant