Evaluation Of Novel Therapeutic Agents (Celecoxib: NSC # 719627) Against Breast Cancer: An Innovative Randomized Phase II Trial Design

Inclusion Criteria

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