Celecoxib and Trastuzumab in Treating Women With Metastatic Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Breast Cancer

Intervention / Treatment
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* Biological: trastuzumab
* Drug: celecoxib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: trastuzumab|nan|
|Drug: celecoxib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, recurrent breast cancer