ICH GCP | Clinical Trials Registry

Alliance for Clinical Trials in Oncology 

National Cancer Institute (NCI) 

Yes

DISEASE CHARACTERISTICS: - Histologically confirmed invasive breast cancer - Metastatic or recurrent disease documented by physical or radiographic examination - Isolated recurrence of breast cancer not considered eligible - Bone disease alone allowed - At least 4 prior courses (or 4 months) of chemotherapy resulting in stable disease, partial response, or complete response - Treated brain metastases allowed provided all of the following conditions are met: - Palliation achieved without evidence of progression for at least 3 months after completion of radiotherapy and/or surgical treatment - At least 30 days since prior dexamethasone or other corticosteroids - Documentation of another site of metastatic disease (in addition to brain metastases) - Measurable or evaluable disease - Pleural or peritoneal effusion as only manifestation of disease allowed if palliated by prior chemotherapy - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal status - Not specified Performance status - CTC (ECOG) 0-2 Life expectancy - Not specified Hematopoietic - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST or ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present) - Albumin at least 3.0 g/dL Renal - Creatinine no greater than 1.5 times ULN Other - Not pregnant or nursing - Fertile patients must use effective contraception - No other active malignancy within the past 2 years except nonmelanoma skin cancer - No active peptic ulcer disease - No known hypersensitivity to sulfonamides, aspirin, or other NSAIDs, including celecoxib PRIOR CONCURRENT THERAPY: Biologic therapy - Concurrent trastuzumab (Herceptin) allowed if initiated at least 3 months prior to study entry Chemotherapy - See Disease Characteristics - At least 6 weeks since prior chemotherapy - No more than 2 prior chemotherapy regimens for recurrent or metastatic disease Endocrine therapy - See Disease Characteristics - Prior hormonal therapy for metastatic disease allowed - No concurrent hormonal therapy except hormones for noncancer-related conditions (e.g., insulin for diabetes) Radiotherapy - See Disease Characteristics - At least 4 weeks since prior radiotherapy - Prior radiotherapy to the breast and for metastatic disease allowed - No concurrent palliative radiotherapy Surgery - See Disease Characteristics Other - Prior adjuvant therapy for metastatic disease allowed - Concurrent bisphosphonates allowed - Concurrent low-dose aspirin (no greater than 325 mg/day) is allowed - No other concurrent therapy with celecoxib or other nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., rofecoxib, aspirin, choline magnesium trisalicylate, ibuprofen, naproxen, etodolac, oxaprozin, diflunisal, nabumetone, or tolmetin) - No concurrent fluconazole

Female

18 Years

120 Years

No

United States

Sponsor

U10CA031946

CALGB-40105

CDR0000256905

Celecoxib

Randomized

Parallel Assignment

Treatment

Triple (Participant, Care Provider, Investigator)