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RATIONALE: Drugs used in chemotherapy, such as pixantrone dimaleate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pixantrone dimaleate in different ways may kill more tumor cells.
- To assess the proportion of confirmed tumor responses in patients with HER2-negative metastatic breast cancer treated with pixantrone dimaleate.
- To describe the distribution of progression-free survival (PFS) times of patients treated with this drug.
- To assess the 6-month PFS rate in patients treated with this drug.
- To describe the overall survival of patients treated with this drug.
- To assess the adverse event profile of this drug in these patients.
- To evaluate the quality of life and patient-reported symptoms of patients treated with this drug.
- To evaluate quantitative and qualitative changes of circulating tumor cells after pixantrone dimaleate therapy. (Correlative study)
- To bank blood and tissue samples for future evaluation of pharmacogenetic and/or proteomic markers. (Correlative study)
OUTLINE: This is a multicenter study. Patients are randomized according to prior doxorubicin treatment ( yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Some patients undergo blood sample collection at baseline and periodically during study for circulating tumor cells analysis by CellSearch System and mRNA isolation assays.
Patients complete quality-of-life questionnaires using the Linear Analogue Self Assessment (LASA6) and the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) at baseline and periodically during study.
After completion of study therapy, patients are followed up every 3-6 months for up to 5 years.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Mayo Clinic Scottsdale
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-23T21:09:50-0400
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