Conditions: Breast Cancer
Keywords: HER2-negative breast cancer male breast cancer recurrent breast cancer stage IV breast cancer stage IIIC breast cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 46
Healthy volunteers: no

Brief 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.

Detailed description:
OBJECTIVES:

Primary

* To assess the proportion of confirmed tumor responses at each dose level of pixantrone

Secondary

* To describe the distribution of progression-free survival (PFS) times of patients receiving pixantrone
* To assess the 6-month PFS rate in patients receiving each dose level of pixantrone
* To describe the overall survival distribution of patients receiving pixantrone
* To assess the adverse event profile of pixantrone in the treatment of patients with metastatic breast cancer.
* To evaluate the quality of life and patient-reported symptoms of patients receiving the study regimen

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.

Arms:
arm 1: 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 2: 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.

Interventions: intervention 1: pixantrone dimaleate
Intervention descriptions: intervention 1: Given IV

Protocol document: