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Sponsored by: |
University of Texas |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00075413 |
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well arsenic trioxide works in treating women with locally advanced or metastatic breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: arsenic trioxide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Pilot Phase II Protocol Of Arsenic Trioxide (TRISENOX) In Subjects With Advanced Carcinoma Of The Breast |
Estimated Enrollment: | 30 |
Study Start Date: | November 2002 |
Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot study.
Patients receive arsenic trioxide IV over 1-2 hours on days 1-5 of week 1 and on days 1 and 5 of weeks 2-8 (for course 1 only). Beginning with course 2 and for all subsequent courses, patients receive arsenic trioxide on days
1 and 5 of weeks 1-8. Treatment repeats every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients who have a complete response (CR) receive an additional course beyond documentation of CR. Patients who have a CR due to local consolidative therapy (e.g., surgery or radiotherapy) receive an additional 2 courses beyond CR.
Patients are followed for 1 month, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 9-24 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer, meeting 1 of the following criteria:
Locally advanced 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
No concurrent radiotherapy except for the following:
Surgery
Other
United States, Texas | |
University of Texas Medical Branch | |
Galveston, Texas, United States, 77555-0209 |
Study Chair: | Dennie V. Jones, MD | University of Texas |
Study ID Numbers: | CDR0000346365, UTMB-02403 |
Study First Received: | January 9, 2004 |
Last Updated: | August 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00075413 History of Changes |
Health Authority: | United States: Federal Government |
stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer recurrent breast cancer stage IIIA breast cancer |
Skin Diseases Arsenic trioxide Breast Neoplasms |
Breast Diseases Recurrence Carcinoma |
Neoplasms Neoplasms by Site Skin Diseases Antineoplastic Agents Therapeutic Uses |
Arsenic trioxide Breast Neoplasms Pharmacologic Actions Breast Diseases |