Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2001-08-31
2003-11-30
Brief Summary
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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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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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bortezomib
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Northwestern University
OTHER
Responsible Party
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Northwestern University
Principal Investigators
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William J. Gradishar, MD
Role: STUDY_CHAIR
Robert H. Lurie Cancer Center
Locations
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Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States
Countries
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Other Identifiers
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NU-NCI00B11
Identifier Type: -
Identifier Source: secondary_id
NCI-1862
Identifier Type: -
Identifier Source: secondary_id
NCI 00B11
Identifier Type: -
Identifier Source: org_study_id