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The 21 experts, all members of the Coalition of Cancer Cooperative Group'sScientific Leadership Council (SLC) in Breast Cancer outlined their consensus-- Research Priorities in Breast Cancer: Recommendations of the ScientificLeadership Council in Breast Cancer of the Coalition of Cancer CooperativeGroups -- at a meeting of physicians, researchers, patient advocates, andgovernment and industry representatives in Dallas September 12-13, and urgedphysicians to enroll as many of their eligible patients into the trials aspossible. The SLC in Breast Cancer was chaired by Julie Gralow, MD, associateprofessor, University of Washington School of Medicine, and Director, BreastMedical Oncology at UW's Seattle Cancer Care Alliance and Edith Perez, MD,Director of the Breast Cancer Program, Division of Hematology/Oncology, andDepartment of Internal Medicine at the Mayo Clinic in Jacksonville, Florida.
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Together, the priority studies require patient enrollment of nearly43,500. To date, about 17,400 patients have been enrolled, leaving more than26,000 patients still needed for these studies. Enrollment of breast cancerpatients in publicly funded studies averages about 9,300 annually(i); thenumber of breast cancer patients on privately funded studies is not known.More rapid enrollment and timely completion of these studies can quicken thepace of diagnostic and treatment advances by resolving clinical questions suchas:
-- How to predict the impact of biological effects of chemopreventiveagents with the development and validation of new, clinically relevantbiomarkers
-- How to design, select - and afford - individualized cancer therapy inan era of escalating costs for biologic treatments
-- How, when and whether to use chemotherapy in breast cancer treatmentfor some patients
-- How to best incorporate novel approaches, including biophosphonates inbreast cancer treatment to reduce the risk of bone metastases
-- How best to address the growing issue of long term neurotoxic andcognitive side effects in breast cancer survivors
-- How to design clinical trials that can be completed more efficientlyincluding randomized discontinuation trials or "adaptive" trial designs thatrequire fewer patients and/or shorter study duration.
Six of the studies are for patients with early-stage breast cancer, threeare studies investigating the use of drugs to shrink tumors or eliminatecancer cells prior to surgery, two are in advanced breast cancer, one focuseson quality of life, and one on effectiveness of partial over whole breastirradiation. A molecular/genetic profiling study will determine whether somewomen typically treated with chemotherapy in addition to hormonal therapybased on clinical characteristics may not need chemotherapy.
Breast cancer remains the most common malignancy in women in the U.S. andis the second most common cause of cancer death. In 2008, it is estimatedthat 182,460 new cases of invasive and 67,770 cases of in situ breast cancerwill be diagnosed in women and 40,480 women will die from the disease.
The SLC also emphasized the importance of connecting patients to prioritytrial information. Research conducted by the Coalition and NorthwesternUniversity shows that only 15 percent of all breast cancer patients are awareof the clinical trial option at time of diagnosis. The Coalition'sTrialCheck(R), Internet-based cancer clinical trial navigation and matchingsystem of all federally registered cancer studies, is designed to help closethis information gap by electronically linking patients to hospitals andpractices near their home
