adjuvant stage 2-3a breast cancer with positive lymph nodes

Conditions: Breast Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. radiation therapy uses high-energy x-rays to damage tumor cells. purpose: this phase ii trial is studying how well giving combination chemotherapy together with filgrastim and radiation therapy works in treating patients with stage ii or stage iiia breast cancer.

objectives: * determine the feasibility of administering adjuvant paclitaxel, dose-intensive cyclophosphamide, and filgrastim (g-csf), followed by doxorubicin and then radiotherapy in patients with stage ii or iiia breast cancer involving \> 4 lymph nodes. * determine the incidence of febrile neutropenia in these patients during the first course of therapy. * compare the incidence of febrile neutropenia and duration of neutropenia in patients treated with this regimen with that seen in patients treated on protocol cwru-4194. * determine the disease-free and overall survival of patients treated with this regimen. * evaluate the quality of life of these patients. * correlate her-2/neu overexpression with disease-free and overall survival in these patients. outline: patients receive paclitaxel iv continuously and cyclophosphamide iv over 2 hours on days 1-3. patients also receive filgrastim (g-csf) subcutaneously (sc) beginning on day 5 and continuing until day 14 or until blood counts recover. treatment repeats every 21 days for 3 courses. patients then receive doxorubicin iv on day 1 and g-csf sc on days 2-11 every 21 days for 4 courses. patients with hormone receptor positive disease also receive oral tamoxifen daily for 5 years beginning at the completion of chemotherapy. beginning 3-6 weeks after the completion of chemotherapy, patients receive radiotherapy 5 days a week for 6-7 weeks. quality of life is assessed days 1 and 4 of the first course of chemotherapy, day 1 of the second course, the last day of the final course, and at 6 months after the completion of treatment. patients are followed every 3 months for 2 years and then every 6 months thereafter. projected accrual: a total of 26 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed stage ii or iiia breast cancer * at least 5 axillary lymph nodes * no t4 or n3 disease * no distant metastases by ct scan of the chest, abdomen, and pelvis; bone scan; and bone marrow evaluation * no more than 8 weeks since prior lumpectomy or mastectomy with axillary node dissection * negative surgical margins * hormone receptor status: * hormone receptor status known patient characteristics: age: * 18 and over sex: * male or female menopausal status: * not specified performance status: * ecog 0-1 life expectancy: * not specified hematopoietic: * wbc at least 3,500/mm\^3 * granulocyte count at least 1,500/mm\^3 * platelet count greater than 100,000/mm\^3 hepatic: * bilirubin no greater than 1.5 times upper limit of normal (uln) * sgot no greater than 1.5 times uln * alkaline phosphatase no greater than 1.5 times uln renal: * creatinine no greater than 1.5 mg/dl cardiovascular: * no poorly controlled ischemic heart disease or congestive heart failure pulmonary: * no severe chronic obstructive or restrictive pulmonary disease other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no severe diabetes mellitus * no other severe concurrent medical or psychiatric illness that would preclude study participation * no other malignancy within past 5 years except curatively treated ductal carcinoma in situ, lobular carcinoma in situ, or breast cancer prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no prior chemotherapy endocrine therapy: * not specified radiotherapy: * no prior radiotherapy surgery: * see disease characteristics

Keywords: stage ii breast cancer stage iiia breast cancer male breast cancer