When Evelyn H. Lauder was diagnosed with breast cancer in 1989, she became a vocal spokesperson for women’s health, and in 1993, along with Larry Norton, MD, now Deputy Physician-in-Chief for Breast Cancer Programs and Medical Director of the Evelyn H. Lauder Breast Center at Memorial Sloan Kettering Cancer Center, founded the Breast Cancer Research Foundation (BCRF), which has since raised more than half-a-billion dollars for research. This year, the BCRF is providing $54 million to fund 240 research projects in 13 countries, making the foundation the largest nonprofit funder of breast cancer research in the world.
In February, the BCRF announced an expansion of its research program with a new collaborative breast cancer–funding model called the BCRF Investigator–Initiated Drug Research Program. The expanded program is intended to bridge the gap between academic investigators and their ability to access drugs in development to speed research in both primary and metastatic breast cancers. Initial funding for the program was provided by a 3-year, $15 million grant from Pfizer Oncology. Researchers funded by this program will also have access to Pfizer’s portfolio of drugs approved by the U.S. Food and Drug Administration (FDA) as well as drugs in its development pipeline.
The ASCO Post talked with Marc Hurlbert, PhD, Chief Mission Officer of the BCRF and Chair of the Metastatic Breast Cancer Alliance, about the Investigator-Initiated Drug Research Program and what may be on the horizon in breast cancer detection and treatment options for metastatic disease.
Pieces of a Massive Puzzle
You recently became Chief Mission Officer of the BCRF. What are the foremost goals you hope to achieve?
Literally, my job title describes my main goal: to prevent and cure breast cancer. More specifically, my goal is to help the scientists we are funding all over the world achieve the goals of their specific research projects. Collectively, each of their projects fits together in a puzzle that, hopefully, will help us answer the key questions in the development of breast cancer and how to cure it. We are funding 240 scientists in 13 countries, so it is a massive puzzle to put together.
Since its founding in 1993, the BCRF has focused on clinical and translational research as well as funded many efforts and trials of the cooperative groups and many of the correlative scientific studies that perhaps would not have been funded as part of the original primary trial. Over the years, we have provided funding for a spectrum of research projects from understanding the basics of how breast cancer starts and prevention strategies to treatment development. We are also now paying more attention to the care of the whole patient to ensure he or she has a good quality of life after treatment ends.
Putting Forth Innovative Ideas
What are you hoping to accomplish with the Investigator-Initiated Drug Research Program?
This program enhances our core mission of advancing academic clinical research. Pfizer Oncology is our first partner in this effort. Pfizer had the innovative idea of working with us because of our focus on research and our world-renowned scientific advisory board, led by our Scientific Director Larry Norton, MD, and Chairman Clifford Hudis, MD [Vice President for Government Relations, Chief Advocacy Officer, Chief of the Breast Medicine Service at Memorial Sloan Kettering Cancer Center, and the newly named next Chief Executive Officer of ASCO], who help us select the best research projects to fund.
This initiative allows academic investigators to lead their research projects and be independent from drug companies for support. Between 20 and 30 years ago, it was common for academic researchers to be involved in these types of research pursuits, but those projects dwindled, as drug companies merged and regulations for clinical trials changed.
Pfizer has given us the funding as well as access to its FDA-approved oncology drugs and to a dozen or more drugs in development. We are now in the midst of holding a competition for academic scientists to put forward their most innovative ideas for funding. (For more information on BCRF grants, visit http://www.bcrfcure.org/grant-guidelines.)
This initiative is focused on drug research, and we hope our partnership with Pfizer will be the first of many similar partnerships with other drug manufacturers, because we think this research can be a game-changer, especially for metastatic disease.
Metastatic Breast Cancer
In addition to your responsibilities at the BCRF, you are also Chair of the Metastatic Breast Cancer Alliance, which is housed at BCRF headquarters. Will the BCRF focus more of its funding resources on metastatic breast cancer?
About one-third of our budget goes to funding metastatic research. In addition, when Evelyn Lauder passed away in 2011, we had an outpouring of financial support. With a huge influx of $31 million in additional funding, in 2012 and 2013, our scientific advisory board looked over what was happening in breast cancer research and decided there was a need for a big investment in metastatic breast cancer, launching the Evelyn H. Lauder Founder’s Fund.
The Founder’s Fund makes grants to three major programs. The first is the AURORA (Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer) European Union (EU) clinical trial, which initially aims to recruit 1,300 patients with breast cancer from hospitals across Europe (clinicaltrials.gov/ct2/show/NCT02102165). AURORA EU is based in Brussels and conducted under the oversight of Martine Piccart-Gebhart, MD, PhD [Professor of Oncology, Université Libre de Bruxelles].
A similar clinical study is scheduled to launch in the United States in June 2016 and is being coordinated by Nancy E. Davidson, MD [Director of the University of Pittsburgh Cancer Institute (UPMC) and UPMC Cancer Centers], with the clinical aspects administered by Antonio C. Wolff, MD [Professor of Oncology, Member of the Breast Cancer Program at Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University] through the Translational Breast Cancer Research Consortium. These trials are trying to identify changes in molecular and genetic markers that occur when breast cancer metastasizes and will follow individual patients to learn how the molecular markers in their metastases change over time.
Part of this study is prospective, so it is enrolling patients whose disease has recurred as well as patients with de novo metastatic disease. Similar to the I-SPY 2 trial, AURORA is looking for actionable mutations to provide treatment options for patients with metastatic disease. And part of the study is retrospective, analyzing previously banked tissue samples from both primary and metastatic tumors that have not been molecularly characterized, to speed our understanding of how cancer cells change and what mutations they are expressing now that they have moved to another part of the body.
The third component of the Founder’s Fund is developing metastasis in culture systems (both in vitro and in vivo) to enable drug screens and validation of therapeutic targets as well as a greater understanding of metastatic processes. We are also interested in studying the potential of liquid biopsy to help predict how individual patients with advanced breast cancer will respond to specific therapies and pinpoint genetic mutations that may impact prognosis.
On the Horizon
Based on the research funded by the BCRF, what treatment options might be on the horizon for patients with breast cancer both in the primary and metastatic settings?
One main area of our research is in understanding what the right combination of a drug cocktail might be to achieve the greatest effectiveness for individual patients. To overcome the problem of drug resistance and cancer recurrence and metastasis, we think the future for comprehensive breast cancer care will be in the use of combinations of drugs—not single agents—that target multiple parts of the cancer cell or microenvironment.
Of course, our ultimate goal is to prevent and cure breast cancer, and, thankfully, many patients are cured of their disease. But for those women and men who have disease recurrence or metastasis, our next greatest hope is to turn their cancer into a chronic, treatable disease such as diabetes, heart disease, or HIV/AIDS, which often can be controlled and kept at bay.
Today, the average lifespan of a person with metastatic disease is 3 years. We want to see if we can turn that into 20 years and beyond. Using the right combinations of drugs will be crucial in this setting. I also believe that immunotherapy may prove to be an important treatment for breast cancer, especially in combination with chemotherapy and radiation therapy, but the science is still being developed.
For more information on the BRCF, please visit http://www.bcrfcure.org. ■
Disclosure: Dr. Hurlbert reported no potential conflicts of interest.
