Originally published as JCO Early Release 10.1200/JCO.2007.15.5242 on December 1 2008

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Phase II Trial of Sorafenib in Patients With Metastatic Breast Cancer Previously Exposed to Anthracyclines or Taxanes: North Central Cancer Treatment Group and Mayo Clinic Trial N0336

Alvaro Moreno-Aspitia, Roscoe F. Morton, David W. Hillman, Wilma L. Lingle, Kendrith M. Rowland, Jr, Martin Wiesenfeld, Patrick J. Flynn, Tom R. Fitch, Edith A. Perez

From the Mayo Clinic and Mayo Foundation, Jacksonville, FL, and Rochester, MN; Iowa Oncology Research Association Community Clinical Oncology Program (CCOP), Des Moines; Cedar Rapids Oncology Project CCOP, Cedar Rapids, IA; Sioux Community Cancer Consortium, Sioux Falls, SD; Metro-Minnesota Community Clinical Oncology Program, St Louis Park, MN; and Scottsdale CCOP, Scottsdale, AZ

Corresponding author: Alvaro Moreno-Aspitia, MD, Division of Hematology/Oncology, 4500 San Pablo Road, Jacksonville, FL 32224; e-mail: morenoaspitia.alvaro{at}mayo.edu

Purpose We conducted a cooperative group phase II study to assess antitumor activity and toxicity of sorafenib in patients with metastatic breast cancer (MBC) who had received prior treatment for their disease.

Patient and Methods Patients were eligible if they had measurable disease and had previously received an anthracycline and/or a taxane in the neoadjuvant, adjuvant, or metastatic setting. The primary end point of the study was tumor response per Response Evaluation Criteria in Solid Tumors (RECIST). The study was designed in two stages. Sorafenib was administered as 400 mg twice daily on days 1 through 28 of each 4-week cycle.

Results Twenty-three patients were enrolled with a median age of 54 years (range, 37 to 70 years). Twenty-two (96%) had prior anthracycline treatment and 16 (70%) had prior taxane treatment. Patients received sorafenib for a median of two cycles (range, one to 15 cycles) with a median follow-up of 2.4 years (range, 2.2 to 2.6 years). There were no grade 4 toxicities and few grade 3 toxicities. Among the 20 patients eligible for efficacy analysis, no patients experienced a partial response or complete response per RECIST criteria. Thus, the trial stopped at the end of the first stage per study design. Two patients (10%; 90% CI, 1.8% to 28.3%) achieved stable disease lasting longer than 6 months.

Conclusion Sorafenib as a single agent, although well tolerated, did not exhibit activity when measured by tumor shrinkage in patients with MBC who had received prior treatment. Further research should focus on combinations with standard therapy and end points more sensitive to effects of targeted agents, such as disease stabilization.

published online ahead of print at www.jco.org on December 1, 2008.

Supported in part by Public Health Service grants CA-25224, CA-37404, CA-35195, CA-37417, CA-35448, CA-63848, CA-35119, CA-35415, CA-35113, CA-25267, CA-60276, and CA-52352 from the National Cancer Institute.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical trial information can be found for the following: NCT00096434 [ClinicalTrials.gov] .

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