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Study 18 of 2072 for search of: | United States, Utah |
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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) Cancer and Leukemia Group B |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00382018 |
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Measuring blood levels of tumor cells may help in learning how well chemotherapy works to kill metastatic breast cancer cells and allow doctors to plan better treatment. When blood levels of tumor cells are high while receiving chemotherapy, it is not yet known whether it is more effective to change chemotherapy regimens at that time or wait until disease progression.
PURPOSE: This randomized phase III trial is studying treatment decision making based on blood levels of tumor cells in women with metastatic breast cancer receiving chemotherapy.
Condition | Intervention | Phase |
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Breast Cancer |
Procedure: chemotherapy |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized |
Official Title: | A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients Who Have Elevated Circulating Tumor Cell Levels at First Follow-Up Assessment |
Estimated Enrollment: | 500 |
Study Start Date: | October 2006 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1: Active Comparator
Patients continue to receive regular treatment without change at the discretion of the physician. Patients are eligible for other first-line chemotherapy trials. No further blood is collected.
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Procedure: chemotherapy
No administration details available
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Group 2: Experimental
Patients continue to receive their current chemotherapy regimen without change.
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Procedure: chemotherapy
No administration details available
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Group 3, Arm I: Active Comparator
Patients continue with their current chemotherapy regimen without change.
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Procedure: chemotherapy
No administration details available
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Group 3, Arm II: Experimental
Patients switch to a different chemotherapy regimen. Selection of a new chemotherapy regimen is made by the patient's doctor.
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Procedure: chemotherapy
No administration details available
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Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Meets 1 of the following criteria:
HER-2 status determined by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH) assay
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Prior hormonal therapy, bisphosphonate therapy, trastuzumab (Herceptin®), and/or bevacizumab for metastatic disease allowed
Investigator: | Jeffrey B. Smerage, MD, PhD | University of Michigan Cancer Center |
Investigator: | Daniel F. Hayes, MD | University of Michigan Cancer Center |
Investigator: | Eric P. Winer, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | CDR0000504319, SWOG-S0500, CALGB-SWOG-S0500 |
Study First Received: | September 26, 2006 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00382018 |
Health Authority: | Unspecified |
recurrent breast cancer stage IV breast cancer |
Skin Diseases Breast Neoplasms Breast Diseases Recurrence |
Neoplasms Neoplasms by Site |