Clinical trial · Interventional
Celecoxib and Trastuzumab in Treating Women With Metastatic Breast Cancer
Phase II Study of Celecoxib in HER-2/Neu Overexpressing Metastatic Breast Cancer Patients Who Have Failed Recombinant Humanized Anti-p 185HER Monoclonal Antibody Trastuzumab (HERCEPTIN)
- 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 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.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| celecoxib | Drug | Celecoxib | ALIAS |
| trastuzumab | Biological | Trastuzumab | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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