Advocate Learning at SABCS and the Future of Clinical Trials
CR Magazine: Collaberation – Results


WEDNESDAY, DEC. 10, 2008

Advocate Learning at SABCS and 
the Future of Clinical Trials (with Martine Piccart)

Posted by Musa Mayer

Greetings from San Antonio! I’ve been coming to the San Antonio Breast Cancer Symposium (SABCS) since 1996, and always come away from these four days of morning-to-night sessions stimulated, recharged and—frankly—exhausted. It’s a great place to meet and hang out with researchers and fellow advocates, while hearing all about the latest science of breast cancer from the experts.

This annual meeting offers an extraordinary opportunity for advocates to learn. Years ago, the Alamo Breast Cancer Foundation established a thriving program that today offers scholarships and mentor sessions to many advocates each year. Graduates of Project LEAD, the National Breast Cancer Coalition’s science training course, spent the morning getting a refresher in the science of signal transduction and epigenetics to help with the grant reviewing most of us do.

There has definitely been a shift in emphasis at SABCS over the years. When I first started coming to San Antonio, most of the presentations were about clinical trials, with a few about observational studies thrown in for good measure. Today, especially with the symposium organizers’ new collaboration with the American Association for Cancer Research, more basic science is being presented at this conference. That’s only as it should be, as molecular biology explodes and expands our knowledge of cancer. The key word here is “translational,” referring to that crucial point in research where findings in basic science in cancer cell lines and in mice move to human testing in clinical trials, and ultimately to applications in the clinic.

Late this afternoon, I attended “Clinical Trials 101,” presented by oncologist and clinical researcher Martine Piccart, of the Jules Bordet Institute in Belgium [listen to a podcast with Piccart (4.65 MB / 4:56 minutes)] and statistician Susan Hilsenbeck, of the Baylor College of Medicine. Piccart is the head of the European cooperative research groups BIG and EORTC. Using the story of Taxol (paclitaxel), a chemotherapy drug, Piccart spoke frankly of the need for a paradigm shift in the design, conduct and support of clinical trials in breast cancer. We design too many of our trials as if breast cancer was one disease, when we know now that it is not. We overtreat, exposing patients to toxic treatments they don’t need and can’t benefit from, because we don’t have a biomarker capable of predicting a tumor’s response to the therapy. Yet we know, from the model of hormonal treatment and targeted therapies for HER2-positive breast cancer—for which scientists have developed tests that predict treatment response—that this is possible.

Taxol was tested in almost 100,000 women with early breast cancer, in multiple randomized trials, at enormous expense, Piccart pointed out, and we still do not know in which patients it works. Not only are patients who don’t benefit suffering side effects of taking the drug, but what she termed “financial toxicity” is an increasing problem around the world, as drug costs far outstrip available resources. Yet, Taxol could have been a targeted therapy. “If we had done a better job,” Piccart says, “we would be in a position of knowing who benefits from the taxanes,” which is the group of drugs that includes Taxol. “We have not a single validated biomarker today to help us identify which women can benefit from these drugs.”

What is the solution? Piccart feels that we must incorporate the latest understandings from basic science into clinical trials. “If we don’t pay attention to the development of robust diagnostics, we will not get to the goal of personalized therapy,” she says. To do this would require a new level of regulatory control over diagnostics, both here and in Europe, so that they can be rigorously validated. It requires a great deal of what is known as “correlative” science: co-developing predictive biomarkers along with the new drugs, which will help to select responders and “enrich” clinical trials, making them much smaller, less costly and more clinically meaningful. Tissue collection and analysis must be a part of clinical trials of the 21st century, Piccart insists. “Clinical trials should have a translational component,” she says. “If they don’t, they are outdated—even unethical.”

While Martine Piccart’s ideas were not new to me, I found it gratifying to hear her issue such a clarion call for the change that needs to come. A visionary like her, in a position of leadership—well, it’s enough to give an advocate hope!