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| Sponsor: | Northwestern University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Northwestern University |
| 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: | Primary Purpose: 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: | August 2001 |
| Study Completion Date: | November 2003 |
| Primary Completion Date: | November 2003 (Final data collection date for primary outcome measure) |
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
| Responsible Party: | William Gradishar, MD, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00028639 History of Changes |
| Other Study ID Numbers: | NCI 00B11, NU-NCI00B11, NCI-1862 |
| Study First Received: | January 4, 2002 |
| Last Updated: | July 1, 2011 |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
|
stage IV breast cancer recurrent breast cancer |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Bortezomib |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |