Targeted therapy is a fast-growing area of cancer treatment that uses drugs or other substances to fight cancers by targeting specific tumor-promoting proteins or pathways. This new class of drugs showed early promise with Tamoxifen and Herceptin, both of which have greatly improved breast cancer survival for many women. Unfortunately, realization of the potential of targeted therapies coincided with diminishing government funding for cancer research, threatening to delay the impact this new knowledge could have on patient outcomes.
Testing new drugs is done through clinical trials, which require not only many patients but also a highly integrated team approach comprised of many different areas of expertise as well as shared resources. They are difficult to conduct in the traditional clinical trial framework, which is expensive—both in dollars and patient years. To address these challenges, a group of clinical trials experts had the foresight and expansive vision to establish the Translational Breast Cancer Research Consortium (TBCRC) in 2005, with founding support from BCRF, soon joined by the Avon Foundation for Women and Susan G. Komen for the Cure. Its goal is to foster multi-institution collaborations to conduct innovative clinical trials that integrate both clinical and laboratory studies to accelerate progress in breast cancer.
“The collaborative structure of TBCRC allows for greater intellectual independence and flexibility to conduct studies that are scientifically important, but not always of interest to individual pharmaceutical companies,” said Dr. Antonio Wolff, a BCRF grantee who has served as TBCRC’s Executive Officer since 2006. “These trials are often too small and too complex to be done through more traditional and established research mechanisms like the National Cancer Institute clinical trial cooperative groups.”
Today, the TBCRC supports more than 200 trial investigators, including medical oncologists, surgeons, radiation oncologists, basic scientists, and imaging specialists. Many BCRF grantees are included in this mix of medical experts. Patient advocates are engaged at every stage of the process to bring a patient voice to the design, approval, and execution of the studies conducted. The consortium also benefits from shared resources that include innovative new technologies in molecular biology and genomics, biological specimens and clinical data across its 17 participating clinical trial sites, all NCI-designated Comprehensive Cancer Centers.
The TBCRC is organized into working groups that address key challenges in breast cancer care, including triple negative and HER2-positive diseases, resistance to anti-hormone therapies and local recurrence after treatment. BCRF grantees Drs. Charles Perou and Hope Rugo co-chair the triple negative breast cancer group, and Dr. James Rae co-chairs the group on endocrine resistance. Drs. Andrea Richardson and Fraser Symmans head up a correlative science working group that advises investigator on best strategies to analyze biological samples to identify predictive biomarkers in tissue and also in blood (“liquid biopsies”) in an effort to guide treatment.
The TBCRC meets in person twice a year, in addition to monthly conference calls for each of the working groups, providing regular opportunities for members to participate in discussions and provide feedback on new proposals. The TBCRC conducts its scientific reviews in a collaborative forum of constructive dialogue with all parties present and participating.
“It’s peer review in real time,” said Dr. Wolff. “It’s another way that TBCRC fosters collaboration to accelerate changes in standards of care that will impact clinical outcomes for patients. Equally or more important, it is been an exceptional opportunity for a new generation of investigators, many who will become leaders in their fields, to propose and successfully run research studies while benefitting from real time expert support from seasoned and experienced researchers.”
One of the newest and largest TBCRC initiatives is AURORA US, the U.S. component of the Evelyn H. Lauder Founder’s Fund, a multi-year international effort to study metastatic breast cancer. AURORA US is utilizing the well-established infrastructure of the TBCRC for the development of clinical trials and the molecular and pathological evaluation of tissue samples to identify the underpinnings of metastasis, and developing strategies to prevent and treat the disease. The multi-disciplinary team led by BCRF’s Dr. Nancy Davidson, in coordination with Dr. Wolff, includes leaders in clinical oncology, pathology, molecular biology, genomics and bioinformatics from within the TBCRC community. Based on past successes of the study investigators and the collaborative spirit fostered by TBCRC and BCRF, these efforts promise to yield exciting new discoveries that will benefit the estimated 150,000 – 200,000 women and men currently living with metastatic breast cancer in the U.S.
Since its inception, more than 2,700 patients have enrolled in 30 TBCRC-designed clinical trials, which cover the spectrum of breast cancers, including triple negative, HER2-positive and hormone receptor positive among others. Trial investigators continue to report results from the completed trials at national meetings and in peer-reviewed journals to forge more collaboration among scientists and drive progress in treatment. BCRF has awarded nearly $14 million to the TBCRC since 2005 and remains proud to support its work, which has been crucial to the development of targeted therapies that are improving outcomes for women and men every day.
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