So-called “personalized medicine” in cancer is gaining ground as new drugs are developed that target known gene mutations. UCCC, a National Cancer Institute-designated comprehensive cancer center, is a world leader in understanding mutations, testing for them and studying drugs that work against them.
The new study, called ISPY-2, will help determine which women with newly diagnosed, locally advanced breast tumors do better: those who receive chemotherapy plus new therapies biologically targeted therapies before surgery or those who receive chemotherapy alone before surgery.
It could take hundreds of thousands of dollars and several years to study a single drug, says Dr. Anthony Elias, breast cancer program director and associate director for clinical research for UCCC.
“This trial sets up a new kind of mechanism that lets us test multiple drugs at nearly two dozen cancer centers at once, starting with three drugs that have been shown to target known gene abnormalities in common subtypes of breast cancer,” Elias says. “Rapid discovery is the name of the game.”
Women who are eligible and agree to participate will first have their breast tumors tested using three high-tech biological screening tools. The results will tell doctors what gene mutations are driving their cancer and if their prognosis is good or poor.
If the gene testing results show a poor prognosis, the patient will be invited to enter the drug trial. Doctors believe they will benefit more from targeted therapy.
“HER2 and triple negative breast cancers are usually bad actors, but some of the ER positive breast cancers can also be aggressive,” Elias says. “Each drug we’re studying have been shown to work against at least one of these breast cancer subtypes.”
About 80 percent of study participants will be randomized to receive a study drug and chemo before surgery, and 20 percent will receive standard care—chemo before surgery. UCCC hopes to enroll at least two women each month in the study, which should open here sometime in May. The study, which will run for five years, could eventually test dozens of new drugs.
Doctors will be looking for “pathologic complete response”—no sign of tumor in breast tissue and lymph nodes at the time of surgery—as an indication that the study drug made a difference. Women who achieve complete pathologic response before surgery generally have better survival odds than those who do not.
As each woman completes the study treatment, information about her outcomes will help researchers decide treatment for the next women to join the trial, which is not typically how cancer drug studies work.
“If the first patients respond well to the drug, it’s more likely that subsequent patients will get that drug,” Elias says. “After a certain number of patients, we can decide if a drug is a success, a failure or needs further evaluation. We hope we can study three or four drugs every nine months or so, which is about twice as fast as usual. And since the study mechanism will be in place, when we’re done testing one drug, we can start studying another drug without creating a whole new trial. That will save years of time and millions of dollars.”
The trial data for the first time will be public, which means that breast cancer researchers across the country will have unprecedented information about what the tumors look like before, during and after treatment, plus long-term outcomes. Usually, the drug developer owns the data and keeps it private.
“With this data available for the first time, researchers at UCCC and elsewhere will be able to use it figure out why people may not get a good response, what pathways are important, what biomarkers are really at play,” Elias says. “I-SPY 2 has the power to move the field forward faster than any trial before it. It will create an enormous resource for the future.”
ISPY-2 is run by a unique public-private partnership led by the Foundation for the National Institutes of Health that includes the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and a large number of partners from major pharmaceutical companies, leading academic medical centers, non-profit and patient advocacy groups. Learn more: www.biomarkersconsortium.org
Information for Patients
• The Colorado arm of the study should be open in early May 2010.
• To learn more or schedule an appointment with the UCCC Breast Cancer Team, please call 720-848-1030.
• To find a participating center near you, visit http://ispy2.org/locations.
About the University of Colorado Cancer Center
The University of Colorado Cancer Center is the Rocky Mountain region’s only National Cancer Institute-designated comprehensive cancer center. NCI has given only 40 cancer centers this designation, deeming membership as “the best of the best.” Headquartered on the University of Colorado Denver Anschutz Medical Campus, UCCC is a consortium of three state universities (Colorado State University, University of Colorado at Boulder and University of Colorado Denver) and five institutions (The Children’s Hospital, Denver Health, Denver VA Medical Center, National Jewish Health and University of Colorado Hospital). Together, our 440+ members are working to ease the cancer burden through cancer care, research, education and prevention and control. Learn more at www.uccc.info.
Contact: Lynn Clark, 303.724.3160, email@example.com