celecoxib and trastuzumab in treating women with metastatic breast cancer

Conditions: Breast Cancer

Summary: rationale: celecoxib may be effective in preventing the further development of cancer. monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. combining trastuzumab with celecoxib may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combining celecoxib and trastuzumab in treating women who have metastatic breast cancer that has not responded to previous trastuzumab.

objectives: * determine the efficacy of celecoxib and trastuzumab (herceptin) in women with her2/neu-overexpressing metastatic breast cancer that is refractory to prior trastuzumab. * determine the safety of celecoxib in these patients. outline: at least 3 weeks after the last dose of prior chemotherapy, patients receive oral celecoxib twice daily. patients continue or restart trastuzumab (herceptin) iv over 30-90 minutes weekly or every 3 weeks. treatment continues in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 12-37 patients will be accrued for this study within approximately 9 months.

Eligibility criteria:
disease characteristics: * histologically proven metastatic breast cancer * her2/neu-positive (overexpressing) tumor tissue * failed prior trastuzumab (herceptin) therapy with or without chemotherapy * resected stage iv disease allowed if evidence of disease * bidimensionally measurable or evaluable disease * no lesions in previously irradiated field except nonbone lesions progressive after radiotherapy * no pleural effusions * no blastic or mixed bony metastases * no palpable abdominal masses * no leptomeningeal disease * brain metastases allowed if: * no concurrent use of steroids * at least 3 months since prior brain irradiation * no evidence of progression of metastases * hormone receptor status: * not specified patient characteristics: age: * 18 and over sex: * female menopausal status: * not specified performance status: * karnofsky 70-100% life expectancy: * at least 3 months hematopoietic: * granulocyte count at least 1,500/mm\^3 * hemoglobin at least 8.0 g/dl * platelet count at least 100,000/mm\^3 hepatic: * ast/alt no greater than 2 times upper limit of normal (uln) * bilirubin no greater than 1.5 times uln renal: * creatinine no greater than 1.5 mg/dl cardiovascular: * lvef at least 50% other: * not pregnant * negative pregnancy test * fertile patients must use effective barrier contraception * no other prior malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer * no other serious medical illness * no severe infection * no severe malnutrition * no prior allergic reactions to sulfonamides or celecoxib prior concurrent therapy: biologic therapy: * see disease characteristics * prior trastuzumab (herceptin) for breast cancer allowed, either as adjuvant/neoadjuvant or for metastatic disease chemotherapy: * see disease characteristics * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * prior cytotoxic therapy for breast cancer allowed, either as adjuvant/neoadjuvant or for metastatic disease endocrine therapy: * see disease characteristics * at least 3 weeks since prior hormonal therapy * prior exogenous hormonal therapy for stage iv disease and/or as adjuvant therapy allowed radiotherapy: * see disease characteristics * at least 4 weeks since prior radiotherapy and recovered * prior localized radiotherapy allowed if no influence on the signal measurable lesion * concurrent localized radiotherapy allowed if no influence on the signal measurable lesion surgery: * see disease characteristics * at least 3 weeks since prior major surgery and recovered * at least 2 weeks since prior minor surgery and recovered

Keywords: stage iv breast cancer recurrent breast cancer