Hypofractionated Radiation Therapy in Treating Patients With Stage 0-IIB Breast Cancer
Condition: Ductal Breast Carcinoma In Situ; Invasive Breast Carcinoma; Stage 0 Breast Cancer; Stage I Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer
MeSH terms: Carcinoma; Breast Neoplasms; Carcinoma in Situ; Carcinoma, Ductal, Breast; Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating
Intervention: Hypofractionated Radiation Therapy
Intervention description: Undergo hypofractionated radiation therapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well hypofractionated radiation therapy works in treating
      patients with stage 0-IIB breast cancer. 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:

          -  Histologically confirmed invasive carcinoma and/or ductal carcinoma in situ (DCIS) of
             the breast

          -  Final pathologic Tis, T1-T3, all must be N0 and M0 status.

          -  Negative inked histologic margins from lumpectomy, with the exception of a focus of
             positive margin at the pectoralis fascia

          -  Radiation oncologist does not plan to treat regional lymph nodes beyond standard whole
             breast tangent fields

          -  Lumpectomy with negative lymph node on surgical evaluation (Isolated tumor cells in
             lymph nodes will be permitted). Patients with invasive carcinoma ≥ 70 yrs and with ER+
             positive tumor ≤ 2.0cm may enroll without surgical lymph node evaluation, per section
             5.1. Patients with Ductal Carcinoma In Situ (DCIS) of the breast only may enroll
             without surgical lymph node evaluation.

          -  Negative serum or urine beta-human chorionic gonadotropin (HCG) in women of
             child-bearing potential =< 7 days prior to registration

               -  A female of childbearing potential is a sexually mature female who has not
                  undergone a hysterectomy or bilateral oophorectomy and has not been naturally
                  postmenopausal for at least 12 consecutive months

          -  Women of child-bearing potential must agree to utilize a form of birth control or
             agree to undergo sexual abstinence during radiation therapy

          -  Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1

          -  Able to provide informed consent and willing to sign an approved consent form that
             conforms to federal and institutional guidelines

        Exclusion Criteria:

          -  Prior radiation therapy to the chest, neck or axilla

          -  Prior history of ipsilateral breast cancer (invasive disease or DCIS); lobular
             carcinoma in situ (LCIS) and benign breast disease is allowed

          -  History of prior or concurrent contralateral invasive breast cancer; benign breast
             disease, LCIS or DCIS of contralateral breast is allowed

          -  Active collagen vascular diseases, such as: systemic lupus erythematous, scleroderma,
             or dermatomyositis

          -  Significant post lumpectomy complications requiring an unplanned re-operation or
             admission for intravenous (IV) antibiotics; re-operation for margins evaluation or
             nodal evaluation is acceptable

          -  Co-existing medical conditions with life expectancy < 5 years

          -  Other malignancy within 5 years of registration with the exception of basal cell or
             squamous cell carcinoma of the skin treated with local resection only or carcinoma in
             situ of the cervix

          -  Neoadjuvant chemotherapy or adjuvant chemotherapy delivered before radiation

          -  Neuroendocrine carcinoma or sarcoma histology

          -  Concurrent radiation sensitizing medications concurrent with radiation, per treatment
             physician