Study available at U-M evaluates reparixin in combination with paclitaxel for metastatic triple-negative breast cancer
Media contact: Nicole Fawcett, 734-764-2220 | Patients may contact Cancer AnswerLine™, 800-865-1125
ANN ARBOR, Mich. – An international clinical trial is testing an investigational study drug designed to target cancer stem cells in women with triple-negative breast cancer.

Triple-negative is the most aggressive kind of breast cancer. Triple negative tumors are negative for estrogen receptor, progesterone receptor and the HER2 protein. Because treatments that target these proteins would not work in triple negative breast cancer, the main treatment for it is chemotherapy.
At the same time, studies show that standard chemotherapy may spare cancer stem cells, the small number of cells within a tumor that fuel its growth and spread. Cancer stem cells are suspected to be a main cause of relapses and metastases after treatment.
Laboratory and animal studies done at the University of Michigan Rogel Cancer Center showed reparixin reduced the presence of breast cancer stem cells and the spread of disease.
Following up on those promising results, a Phase Ib study in patients with metastatic breast cancer was initiated and completed. That study provided further data on the combination of reparixin with chemotherapy and determined the recommended phase II dose.
The University of Michigan is one of more than 50 sites around the world to launch a randomized Phase II trial of the investigational drug in combination with paclitaxel to study the combination in patients with metastatic triple-negative breast cancer. Enrolled patients are given the chemotherapy drug paclitaxel (brand name Taxol) in conjunction with either reparixin or placebo.
Anne Schott, M.D., professor of internal medicine, is the principal investigator of the trial at U-M. The investigational drug was developed by the Milan-based Italian biopharmaceutical company Dompé Farmaceutici, which is funding the study.
Breast cancer stem cells are like “blank-slate” cells with the ability to grow into any of the multiple types of cells found in a breast tumor—including those that leave the primary tumor, travel through the body, and establish distant metastatic growths. U-M researchers were the first to identify breast cancer stem cells. Cancer stem cells have also been identified in other cancer types, including prostate, brain, colon and pancreas.
“Finding a way to target and destroy breast cancer stem cells could dramatically change how we treat cancer and potentially lead to longer remissions for women with advanced breast cancer,” Schott says.
Reparixin works by blocking a protein receptor called CXCR1 that can be found on the surface of breast cancer stem cells. CXCR1 can protect cancer stem cells from dying in the presence of chemotherapy. In laboratory studies, reparixin reduced breast cancer metastases, and when combined with chemotherapy it reduced growth of breast tumors.
“Preclinical research suggests that treatments aimed at eradicating cancer stem cells directly may result in more durable responses to therapy,” says Marcello Allegretti, M.D., chief scientific officer of Dompé Farmaceutici.
Learn more about this study by calling the U-M Cancer Answer at 800-865-1125