Pixantrone Dimaleate in Treating Patients With HER2-Negative Metastatic Breast Cancer
Summary
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.
PURPOSE: This randomized phase II trial is studying how well pixantrone dimaleate works in treating patients with HER2-negative metastatic breast cancer.
Description
OBJECTIVES:
Primary
- To assess the proportion of confirmed tumor responses in patients with HER2-negative metastatic breast cancer treated with pixantrone dimaleate.
Secondary
- 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.
Study Design
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Conditions
Breast Cancer
Intervention
pixantrone dimaleate
Location
Mayo Clinic Scottsdale
Scottsdale
Arizona
United States
85259-5499
Status
Recruiting
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01086605
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-07-23T21:09:50-0400
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Medical and Biotech [MESH] Definitions
Breast Cancer Lymphedema
Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).
Inflammatory Breast Neoplasms
Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.
Carcinoma, Lobular
A infiltrating (invasive) breast cancer, relatively uncommon, accounting for only 5%-10% of breast tumors in most series. It is often an area of ill-defined thickening in the breast, in contrast to the dominant lump characteristic of ductal carcinoma. It is typically composed of small cells in a linear arrangement with a tendency to grow around ducts and lobules. There is likelihood of axillary nodal involvement with metastasis to meningeal and serosal surfaces. (DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1205)
Capecitabine
A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.
Mucin-1
Carbohydrate antigen elevated in patients with tumors of the breast, ovary, lung, and prostate as well as other disorders. The mucin is expressed normally by most glandular epithelia but shows particularly increased expression in the breast at lactation and in malignancy. It is thus an established serum marker for breast cancer.
