Trial enrollees sought; effort involves sharing tumors’ responses to therapy in massive public online database.
Ten women with advanced breast cancer will participate in one of the most intensive clinical trials ever conducted to identify molecular changes in individual tumors and to understand the strategies cancers adopt to escape chemotherapy. The study is seeking enrollees.
University of Washington scientists, along with colleagues from more than a half-dozen other institutions, are analyzing tumors’ genomic, transcriptomic, proteomic and metabolomic data – a so-called “panomic” approach. The study is called the “Intensive Trial of OMics in Cancer,” or ITOMIC.
“Each cancer has a unique combination of genomic changes that drives a tumor’s behavior,” said Anthony Blau, UW professor of medicine and the study’s principal investigator. “Our goal is to understand the inner workings of each individual patient’s tumor.”
The study also is an early step to creating a massive, open-access, online database that will provide cancer specialists with more pinpointed information to optimize current and future patients’ treatment.
“There’s a good chance that the women who join this first trial will not benefit directly from what we learn, but women who follow them eventually will. The contribution of the women enrolling in this trial is invaluable and their decision to participate, frankly, heroic,” Blau said.
One of the first enrollees, Cathy Olivas, 56, of Auburn, Wash., was first treated for breast cancer in 2007. The cancer returned in a more aggressive form last June. “I know this research will take many years. I am doing this for other women with breast cancer; that’s very important for me. We have to get a hold on this disease,” Olivas said.
To enroll, a woman must have metastatic, triple-negative breast cancer and be about to begin treatment with the chemotherapy drug cisplatin. Such breast cancers lack three types of receptors – estrogen, progesterone and HER2/neu – involved cell-growth regulation. Tumors that lack these receptors are extremely aggressive and are currently incurable once they have spread. About one in five women with breast cancer has triple-negative disease.
The trial subjects will undergo as many as seven biopsies at tumor and metastatic sites immediately before starting the cisplatin treatment. The biopsied tissue will be analyzed to identify molecular susceptibilities that will be detailed and provided to the patient and her doctor.
Each patient’s analysis will be cross-referenced online with that of other trial participants as well as with external cancer databases in the public domain. Sharing the information will allow researchers at many institutions to use it.
A panel of experts from the participating institutions will review each patient’s findings. Reviews and suggested potential treatment options will be provided to the patient and her doctor. Patients who choose to pursue a recommended treatment will receive assistance in gaining access to those drugs.
“One goal of the project is to dismantle the firewall that exists between the latest research and clinical care that often makes it difficult for patients to gain access to promising new treatments,” said Blau, director of UW Medicine’s Center for Cancer Innovation.
Each patient’s response to treatment will be followed, and, if her cancer returns or fails to respond, the biopsies and panomic analysis will be repeated with the goal of identifying molecular changes that explain the treatment failure.
The research collaborative has now enlisted more than 70 researchers from more than six West Coast institutions including the UW and the Fred Hutchinson Cancer Research Center; the University of California, Santa Cruz; The Institute for Systems Biology in Seattle; Northwest Medical Specialties and Seattle Cancer Care Alliance.