Researchers test promising, investigational drug for metastatic breast cancer

Monday, May 21, 2001

JACKSONVILLE, Fla., May 21, 2001 — Breast cancer researchers at Mayo Clinic in Jacksonville, Fla., are joining colleagues at eight other selected institutions around the world to study a new, investigational treatment for metastatic breast cancer. The Phase II clinical trial of an epothilone analog, BMS-247550, is designed to test the effectiveness of administering the drug as a one-hour intravenous infusion every three weeks.

If breast cancer spreads to other parts of the body (metastasizes) it is incurable using hormonal manipulation or standard-dose chemotherapy. Patients survive, on average, three years once metastatic breast cancer has been diagnosed. Therefore remission of the disease, with an improvement in survival, is an important goal of cancer treatment.

A class of drugs called taxanes, which includes paclitaxel and docetaxel, used alone or in combination with other drugs, is currently one of the most effective treatments for metastatic breast cancer.

However, many patients eventually develop taxane resistance, which manifests itself as regrowth of the cancer. BMS-247550 is a semi-synthetic version of a natural product, epothilone B. BMS-247550 interferes with the process of cell division, as do taxanes, yet in preclinical trials, the drug demonstrated effectiveness against cancer cells insensitive or resistant to paclitaxel.

Oncologist Dr. Edith Perez is the principal investigator for the study at Mayo Clinic. "This is an example of a new treatment approach to breast cancer," she says, "developed as a result of improved understanding of the molecular basis of this disease. We hope that the novel mechanism of action of this agent will translate into improved outcomes for women with breast cancer."

Bristol-Myers Squibb is conducting the study. Women eligible to enroll must have metastatic breast cancer with at least one bidimensionally measurable lesion. Additionally, they cannot have had any prior chemotherapy for metastatic disease; they must have received anthracycline (doxorubicin or epirubicin) as part of their adjuvant breast cancer treatment; and they must not have received taxane unless it was in the adjuvant setting more than a year before enrolling in this clinical trial. Other exclusion criteria apply, but interested women should discuss enrolling in this trial with their physician.

Media contact: Erik Kaldor 904-953-2299 kaldor.erik@mayo.edu

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