Accelerated Radiation Therapy After Surgery in Treating Patients With Breast Cancer
Condition: Inflammatory Breast Cancer; Invasive Ductal Breast Carcinoma; Invasive Lobular Breast Carcinoma; Mucinous Ductal Breast Carcinoma; Papillary Ductal Breast Carcinoma; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Tubular Ductal Breast Carcinoma
MeSH terms: Carcinoma; Breast Neoplasms; Carcinoma, Ductal, Breast; Inflammatory Breast Neoplasms; Carcinoma, Lobular
Intervention: External beam radiation therapy
Intervention description: Hypofractionated accelerated radiation therapy over 11 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well giving accelerated radiation therapy (RT) after surgery
      works in treating patients with breast cancer. RT uses high energy x rays to kill tumor
      cells. Giving RT after surgery may kill any remaining tumor cells
    

Eligibility criteria:

        Inclusion Criteria:

          -  Invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies;
             invasive lobular carcinomas are allowed

          -  American Joint Committee for Cancer (AJCC) Stage IIa - IIIc (pathologic stage T0N1-3,
             T1N1-3, T2N1-3, T3N0-3, T4N0-3, all M0 status) histologically confirmed invasive
             carcinoma of the breast treated with mastectomy and either sentinel node biopsy or
             axillary dissection; inflammatory carcinoma (T4d) is allowed

          -  Patients with locally advanced breast cancer on clinical exam and diagnostics ( > 3 cm
             and/or clinically node-positive) who have mastectomy after induction chemotherapy are
             allowed

          -  Multifocal/multicentric disease is allowed

          -  Negative inked histologic margins of mastectomy (no invasive cells at margin) or
             positive margin at pectoralis fascia or skin

          -  Tamoxifen, Arimidex or other hormonal therapy is allowed; it may begin any time
             relative to the radiation at the discretion of the treating physician

          -  Chemotherapy is allowed, if chemotherapy is indicated the chemotherapy can be
             delivered first, followed by radiation therapy beginning 21-63 days after the last
             cycle of chemotherapy or the radiation therapy can be delivered first and the
             chemotherapy can be delivered no earlier than 21 days post radiation therapy;
             neoadjuvant chemotherapy is allowed; radiation therapy will be delivered after
             mastectomy or after any adjuvant chemotherapy as described above

          -  Chest wall reconstruction is allowed

          -  The patient must be enrolled and have treatment planning between 14-63 days from date
             of last surgery or last cycle of chemotherapy, and radiation must start within 21-63
             days of date of last surgery or last cycle of chemotherapy

          -  Signed study-specific informed consent form prior to study entry

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

        Exclusion Criteria:

          -  Patient with distant metastases (M1)

          -  Patients with ductal or lobular carcinoma in-situ alone (no invasive component) and
             patients with non-epithelial breast malignancies such as sarcoma or lymphoma

          -  Patient with T1N0 or T2N0 disease

          -  Prior radiation therapy to the chest

          -  Patients with collagen vascular diseases, specifically systemic lupus erythematosus,
             scleroderma, or dermatomyositis

          -  Patients with co-existing medical conditions with life expectancy < 2 years

          -  Patients with psychiatric (with the possible exception of incompetence as defined by
             New Jersey [NJ] law) or addictive disorders that would preclude obtaining informed
             consent

          -  Other malignancy, except non-melanomatous skin cancer, < 5 years prior to
             participation in this study; the disease-free interval from any prior carcinoma must
             be continuous

          -  Women who are pregnant or lactating due to potential exposure of the fetus to RT and
             unknown effects of RT to lactating females

          -  Women who are able to conceive and unwilling to practice an effective method of birth
             control; women of childbearing potential must have a negative urine or serum pregnancy
             test within 7 days prior to treatment