Clinical trial · Interventional
Celecoxib in Treating Women With Metastatic or Recurrent Breast Cancer
Evaluation Of Novel Therapeutic Agents (Celecoxib: NSC # 719627) Against Breast Cancer: An Innovative Randomized Phase II Trial Design
NCT00045591CI-TRIAL-00025437terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. It is not yet known which regimen of celecoxib is more effective in treating breast cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of celecoxib in treating women who have metastatic or recurrent breast cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| celecoxib | Drug | Celecoxib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Celecoxib 100 mg
- interventionNames
- Drug: celecoxib
- type
- EXPERIMENTAL
- label
- Celecoxib 400 mg
- interventionNames
- Drug: Celecoxib
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- 28 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.