John A. Olson, Jr., MD, PhD

2009-2010 BCRF Project:
Co-Investigators: Matthew J. Ellis, MD, PhD, Washington University School of Medicine, St. Louis, MO; and Kelly K. Hunt, MD, University of Texas MD Anderson Cancer Center, Houston, TX

On behalf of the American College of Surgeons Oncology Group
In 2004 the Dr. Ellis engaged the American College of Surgeons Oncology Group and the Cancer Treatment Evaluation Program at the National Cancer Institute to conduct a cooperative group neoadjuvant aromatase inhibitor trial. The Z1031 trial, activated in 2006, is a randomized open label comparison between the three FDA approved aromatase inhibitors (letrozole, anastrozole and exemestane) before surgery in postmenopausal women with clinical stage 2 and 3 ER rich breast cancer, with clinical response as the primary endpoint. Although the monthly accrual rate is on target and the trial is estimated to close in late summer 2009, an amendment (A6) to include an additional patient cohort (Z1031-Cohort B) has been approved by CTEP and is pending approval. The approach in Cohort B focuses on the validation of a simple biopsy-based test to identify patients with estrogen receptor positive but endocrine therapy resistant tumors who require an alternative and more effective treatment approach. The trial continues to provide the availability of pre and post endocrine treatment tissue samples that will allow valuable new insights into the biological basis for the success and failure of endocrine therapy.

Mid-Year Progress Report:
In 2004 Dr. Ellis engaged the American College of Surgeons Oncology Group and the Cancer Treatment Evaluation Program at the National Cancer Institute to conduct a cooperative group neoadjuvant aromatase inhibitor trial. The Z1031 trial, activated in 2006, is a randomized open label comparison between the three FDA approved aromatase inhibitors, with clinical response as the primary endpoint. Although the monthly accrual rate is on target and the trial was estimated to close in late summer 2009, an amendment (A6) to include an additional patient cohort (Z1031-Cohort B) has now been activated. The approach in Cohort B focuses on the validation of a simple biopsy-based test to identify patients with estrogen receptor positive, but endocrine therapy resistant tumors who require an alternative and more effective treatment approach. Accrual is proceeding on target with an estimated completion in early 2011.

Bio: