Ana Maria Gonzalez-Angulo, MD, MSc
Associate Professor of Medicine
2012-2013 BCRF Project:
On behalf of SWOG
Departments of Breast Medical Oncology and Systems Biology
University of Texas MD Anderson Cancer Center
RxPONDER (Rx for Positive Node, Endocrine Responsive Breast Cancer) (S1007) is a clinical trial led by SWOG and carried out by the North American Breast Cancer Group (NABCG). It is a Phase III randomized clinical trial of best endocrine therapy versus best endocrine therapy plus chemotherapy that will reveal whether chemotherapy benefits patients with node positive breast cancer who have a low to intermediate Oncotype DX Recurrence Score result. The trial also seeks to determine whether there is an optimal Recurrence Score cut point, above which chemotherapy should be recommended.
This trial presents the perfect opportunity to do systematic research to compare the clinical effectiveness and cost-effectiveness of breast cancer care based on genomic tools and markers compared to existing standards of care that do not use genome-based approaches. Researchers led by Dr. Gonzalez-Angulo and others at SWOG believe that this study will answer one of the most important scientific and clinical questions in breast oncology, and if successful, this would be a practice-changing trial for patients.
The protocol was activated at the National Cancer Institute website on January 15, 2011, under the name NCT01272037. Currently, 425 centers in the United States have opened the clinical trial, and 212 more centers in the US and Canada — as well as other international sites including Spain, Korea, Mexico, Peru, and Ireland — are preparing to do so.
To date, 929 patients have been registered and are currently in some phase of testing for Oncotype DX, of whom 416 have been randomized. BCRF funding will be used in conjunction with National Cancer Institute funds to complete the trial.
Mid-year Progress: Two years into the activation of the study, 460 centers in the US have opened the protocol; with 233 additional centers in the US and Canada (as well as multiple international sites including Spain, Korea, Mexico, Peru, and Ireland) currently under IRB reviews. The international sites are accruing successfully and will provide valuable information on both OncotypeDX and patient outcomes in diverse populations outside North America. To date, 2,026 patients have been registered and have had tissues tested or are undergoing testing for Oncotype DX. About 900 patients have been randomized, which is more than double the number reported since May 2012.
Dr. Gonzalez-Angulo attended medical school at the Universidad del Cauca in Colombia and moved to the U.S. to continue her training. She completed a residency in Internal Medicine at the Mount Sinai Medical Center in Miami, and a Fellowship in Medical Oncology at the Ochsner Clinic Foundation in New Orleans. She then went to the University of Texas MD Anderson Cancer Center to specialize in breast cancer as she was selected as the Susan G. Komen Breast Cancer Fellow. She remains on the MD Anderson faculty and works exclusively with breast cancer patients and in breast cancer research.
She is interested in aggressive types of breast cancer including triple receptor-negative disease. Her research focuses on mechanisms of resistance to standard breast cancer therapies, and on the development of markers to predict response to treatments using functional proteomics and mutation analyses. She is funded by the NCI, ASCO, The Breast Cancer Research Foundation, Komen for the Cure, AACR (SU2C) and the Commonwealth Foundation for Cancer Research.
She is the Chair of the Endocrine Resistance Working Group and a member of the Correlative Sciences Working Group for the Translational Breast Cancer Research Consortium, and a member of the Breast Cancer Committee of SWOG and of the BIG-NABCG Triple Negative Working Group. She serves as a member of the steering committee of The United States - Middle East Partnership for Breast Cancer Awareness and Research and the Partnership for Breast Cancer Awareness and Research of the Americas.