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.

Timeline

Start

2010-05

Primary completion

2012-01

Completion

2014-11-15

Outcome

Missed primary endpoint

paper Forty-five patients were evaluable, with 2 confirmed partial responses in group A and 1 in group B. PMID 35445723 ↗

paper The trial was terminated due to insufficient activity. PMID 35445723 ↗

paper Pixantrone has insufficient activity in the second- and third-line MBC setting. PMID 35445723 ↗

Publications

• Sideras K, Hillman DW, Giridhar K, Ginos BF, Tenglin RC, Liu H, Chen B, Tan W, Gross GG, Mowat RB, Dueck AC, Perez EA, Moreno-Aspitia A. Randomized Phase II Study of Two Doses of Pixantrone in Patients with Metastatic Breast Cancer (NCCTG N1031, Alliance). Oncologist. 2022 Apr 21;27(5):338-e368. doi: 10.1093/oncolo/oyab065. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pixantrone	Small molecule	85 mg/m2	Intravenous
Subject	Pixantrone	Small molecule	180 mg/m2	Intravenous

Indications