PS-341 in Treating Women With Metastatic Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating women who have metastatic breast cancer.

Detailed Description
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OBJECTIVES: Determine the objective tumor response in women with metastatic breast cancer treated with bortezomib. Determine the toxic effects of this drug in these patients. Determine the progression-free survival in patients treated with this drug. OUTLINE: Patients receive bortezomib IV over 3-5 seconds twice weekly for 2 weeks. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 6-24 months.

Official Title
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A Phase II Study of the Proteasome Inhibitor PS-341 (NSC 681 239) in Patients With Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: bortezomib


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the breast Metastatic disease At least 1 unidimensionally measurable lesion At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan Previously treated with 1 prior chemotherapy regimen (with or without trastuzumab [Herceptin]) for metastatic disease Relapse during or within 6 months after completion of adjuvant chemotherapy considered treatment failure No known brain metastases Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm^3 Absolute neutrophil count greater than 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin normal SGOT/SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: No uncontrolled concurrent illness No ongoing or active infection No psychiatric illness or social situation that would preclude study No prior allergic reaction attributed to compounds of similar chemical or biological composition to bortezomib No other prior malignancy within the past 5 years unless curatively treated and disease free Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: Prior hormonal therapy for metastatic disease allowed At least 4 weeks since prior hormonal therapy and recovered Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified Other: Prior adjuvant therapy allowed At least 4 weeks since prior investigational drugs and recovered No other concurrent investigational or commercial agents or therapies for breast cancer No concurrent combination antiretroviral therapy for HIV

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 |
| --- |
|Drug: bortezomib|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