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| Sponsor: | Robert H. Lurie Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00028639 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: bortezomib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Study of the Proteasome Inhibitor PS-341 (NSC 681 239) in Patients With Metastatic Breast Cancer |
| Study Start Date: | January 2002 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the breast
At least 1 unidimensionally measurable lesion
Previously treated with 1 prior chemotherapy regimen (with or without trastuzumab [Herceptin]) for metastatic disease
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| Study Chair: | William J. Gradishar, MD | Robert H. Lurie Cancer Center |
More Information
| Study ID Numbers: | CDR0000069114, NU-NCI00B11, NCI-1862 |
| Study First Received: | January 4, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00028639 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer recurrent breast cancer |
|
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Therapeutic Uses |
Bortezomib Breast Neoplasms Enzyme Inhibitors Pharmacologic Actions Breast Diseases Protease Inhibitors |