Julie R. Gralow, MD

1) On behalf of the Southwest Oncology Group
(made possible by generous support from Play For P.I.N.K.)
Co-Investigator: Peggy I. Porter, MD, University of Washington, and Fred Hutchinson Cancer Research Center, Seattle

The Breast Cancer Research Foundation has funded several SWOG Breast Cancer Clinical Trial efforts. These include a trial studying why older cancer patients either do or do not enroll in a cancer clinical trial. The trial has been completed and the researchers are hoping to the barriers to clinical trials participation in older patients and develop successful interventions to overcome them. Another funded project is using the valuable tool of tissue microarray (TMA) to study the tumors of breast cancer patients enrolled in clinical trials. One way to improve treatment of breast cancer is to develop tests that predict for the likelihood of response or resistance to certain drugs. A third funded study in development will seek to determine the safety and efficacy of using additional chemotherapy and/or biologically targeted therapy for patients who have residual disease after preoperative chemotherapy. A fourth funded trial seeks to identify and develop a registry for women diagnosed with breast cancer who have a prior history of treatment for lymphoma.

A clinical trial is also proposed to evaluate the role of serial blood tumor markers added to standard clinical follow-up care to try to detect early metastatic recurrence of cancer combined with early initiation of anti-cancer therapy, in impacting survival and outcome. Part of this study is to conduct some patient advocacy focus groups, consisting of a group of patients who would discuss the proposed serial tumor marker testing and the issues involved from a patient perspective, i.e. whether or not patients would be willing to enroll, what some of the barriers to accrual might be, etc. This could offer valuable information as to how the trial should be conducted as well as its enrollment success.

Finally, BCRF is partially supporting a randomized 4,500-patient multi-center SWOG trial currently ongoing, to determine whether adjuvant biphosphonates (a class of drug which strengthens bone) can prevent bone metastasis and improve survival in early stage breast cancer patients.

Mid-Year Progress Report:
An analysis of the trial studying why older cancer patients either do or do not enroll in a cancer clinical trial was presented in San Antonio in December, 2009, and a manuscript is being prepared. A large, randomized 5,500-patient multi-center SWOG trial is currently ongoing, to determine whether adjuvant biphosphonates (a class of drug which strengthens bone) can prevent bone metastasis and improve survival in early stage breast cancer patients. The study completed accrual February 1, 2010, and patients will continue to be treated for three years and followed for bone recurrence.

The trial to determine the safety and efficacy of using additional chemotherapy and/or biologically targeted therapy for patients who have residual disease after preoperative chemotherapy continues; the researchers hypothesize that treatment with additional therapy may result in improvement in disease-free survival. Studies on the other BCRF-funded trials continue.

2) On behalf of Memorial Sloan-Kettering Cancer Center, The Breast International Group (BIG) and The Breast Cancer Intergroup of North America (TBCI)
Co-Investigators: Fatima Cardoso, MD, Jules Bordet Institute; Monica Morrow, MD, Memorial Sloan-Kettering Cancer Center; Martine J. Piccart-Gebhart, MD, PhD, Jules Bordet Institute, Beldium; William C. Wood, MD, Emory Universit

In contrast to their female counterparts, men rarely develop breast cancer. In the US, less than 1% of all breast cancers are diagnosed in men. Doctors have a limited understanding of how to approach such an uncommon disease. Most decisions regarding treatment are based upon large clinical trials involving only women with this disease. However, there are important differences regarding the age at diagnosis, underlying risk factors, and biological characteristics which suggest that male breast cancer (Male BC) may be a distinct disease. In order to develop more appropriate treatment recommendations, a better understanding of the natural history and biology of Male BC is desperately needed. Due to the rarity of this disease, such insight can only be gained through co-operation between hospitals in different countries worldwide.

The Breast International Group, the Breast Cancer Intergroup of North America and Memorial Sloan-Kettering Cancer Center have joined forces to launch a three-part International Program on Male Breast Cancer (International Registration and Biologic Characterization Program). The first part of this Program consists of a retrospective joint analysis of a very large series of men previously diagnosed with breast cancer. This initiative will gather data regarding patient characteristics, tumor features, treatment and outcome for more than 1600 men diagnosed with breast cancer over the last 20 years. Tumor specimens (both paraffin-embedded and frozen) from a large proportion of these patients will be collected and centrally analyzed, to understand the biological characteristics of this disease and to identify important potential prognostic (indicative of the good or bad outcome of the disease) and predictive (indicative of probability of response to certain therapies) markers, which will then be validated in the third part of the Program.

This important study will provide invaluable information regarding the behavior of this rare disease and, combined with the information gathered during the second part of the Program (an international Male BC registry), will form the basis and rationale for the design of an international Male BC clinical trial.

During the past year, the preparatory work needed to launch this study has been done. The full protocol and the selection of centers have been accomplished. The database for collection and analysis of both clinical and pathological data is in advanced stages of development. The central labs have started developing common protocols for the construction of TMAs, for the analysis of the different biomarkers and for the reporting of the results. The researchers plan to have centers/groups active by July and to start the collection of data and material by the fall 2009 and they are aiming at finalizing the central pathology review by the end of 2009.

Mid-Year Progress Report:
During this period the preparatory work needed to launch this study has been done. The full protocol and database development for collection and analysis of both clinical and pathological data are finished. The central labs have developed common protocols for the construction of tissue microarrays (TMAs), for the analysis of the different biomarkers and for the reporting of the results. The participant centers/groups were selected and the activation process started. The researchers plan to start the actual collection of data and tumor samples in February and are aiming at finalizing the central pathology review by the mid of 2010. The objective is to analyze the first results of the retrospective male breast cancer (Male BC) study in 2010 as well as present it in an international conference and to prepare a manuscript for publication in a peer reviewed journal. In parallel, they are continuing their efforts to obtain the much needed funds for the associated correlative translational research projects. To this end, additional grant applications will be made by the study coordinators and two central pathologists.

Bio:
Julie Gralow majored in Biologic Sciences as an undergraduate at Stanford University, attended medical school at the University of Southern California in Los Angeles, and trained as a resident in Internal Medicine at Brigham and Women's Hospital in Boston. Her Medical Oncology fellowship training was performed at the University of Washington School of Medicine and the Fred Hutchinson Cancer Research Center.

As a breast cancer specialist and academician, Dr. Gralow's time is split between patient care, education, and clinical research. She is the principal investigator on several clinical trials related to breast cancer prevention and treatment, and is committed to patient education, outreach and wellness. She is co-chair of the Southwest Oncology Group's Breast Cancer Committee, and serves as chair of the American Society of Clinical Oncology's Cancer Communications Committee.

Dr. Gralow is also Medical Director, Team Physician and co-founder of Team Survivor Northwest, an exercise and fitness program for women cancer survivors. She is co-author of "Breast Fitness: An Optimal Exercise and Health Plan for Reducing Your Risk of Breast Cancer".