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Women with breast cancer who have large, aggressive tumors typically face tough treatment options and poor survival rates. A groundbreaking nationwide clinical trial aims to change that. The Arizona Cancer Center is participating in a five-year, $26 million study known as the I-SPY 2 TRIAL, which will determine whether personalized medicine and a new approach to drug studies can bring promising new cancer therapies to the market sooner.
One of the biggest difficulties in cancer treatment is that patients with the same type of cancer often respond differently to the same treatment. The reason: all tumors are not created equal. Even patients diagnosed with the same type of cancer may have tumors with different traits. Those traits, known as biomarkers, may make a tumor more or less vulnerable to particular medications.
The I-SPY 2 TRIAL, which stands for Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis 2, is designed to use biomarkers from individual patients’ tumors to identify which promising new targeted therapies are most effective in specific types of tumors.
“We can actually learn from every patient on the trial,” said Julie E. Lang, MD, director of the Arizona Cancer Center’s Breast Surgical Oncology Program and the local principal investigator of the study. “We’re looking at the features of the patients’ tumors and using that to make decisions about what medicines to give them for their therapy. This is a way to personalized medicine.”
The I-SPY 2 study will test combining investigational drugs with standard chemotherapy before surgery for women with newly diagnosed, locally advanced breast cancer tumors 2.5 centimeters or larger, a population for which an improvement over standard treatment could dramatically increase the odds of survival, said Dr. Lang.
About I-SPY 2
The I-SPY 2 TRIAL at the Arizona Cancer Center is now open to women with newly diagnosed invasive breast cancer. Women with tumors that are 2.5 centimeters or later are eligible to be screened to determine if they meet the requirements necesaary to participate in the treatment phase of the study.
Call (520) 694-CURE (2873) to make an appointment for screening at the Arizona Cancer Center. For more information about the trial, please visit www.ispy2.org.
Of the almost 200,000 women in the United States annually diagnosed with breast cancer, 10 to 20 percent have locally advanced breast cancer. More than a quarter of these women are under the age of 40. While these non-metastatic tumors are operable, successful treatment options remain limited and the risk of recurrence and death is significantly higher in this population, which has five-year survival rates of 60 percent.
“We’re dealing with the most high-risk breast cancer patients,” Dr. Lang said. “The data from this trial is likely to benefit all breast cancer patients, but in particular it will benefit the high-risk patients who are most in need of better answers.”
The study will enroll about 800 patients at around 20 medical centers across the nation. Dr. Lang, who is also an assistant professor of surgery at the University of Arizona College of Medicine, hopes to enroll around 18 women a year in the study at the Arizona Cancer Center.
“We treat a lot of patients who have these large locally advanced tumors so this is a very meaningful study for our center,” she said. “I’m hoping that patients will travel to our center to get on this trial because they will get access to medicines they could not get unless they were on a clinical trial.”
The I-SPY 2 study is unprecedented in its design and scope and could change the way that future clinical trials are done, said Dr. Lang. The study is unusual in several ways: it’s sponsored by a public-private partnership (Read more on Page 8.), it involves up to 12 experimental drugs from several different pharmaceutical companies, participant results are followed in real-time to allow researchers to determine more quickly which investigational drugs combat particular tumor characteristics, and the drug trial is being conducted before the tumor is surgically removed.
“Rather than giving patients therapy after surgery and waiting to see if they survive, we can actually use the tumor itself to measure if there’s a response to the therapy,” said Dr. Lang, who added that having chemotherapy before versus after surgery has no impact on patient outcome.
A key feature of the study is a molecular analysis to determine whether participants’ tumors are positive or negative for estrogen, progesterone and the HER2 protein — the basis for putting patients in one of the biomarker categories.
“This study is all about biomarkers and assessing response to therapies and really understanding more about the tumors,” said Dr. Lang. “Rather than giving everyone the same chemotherapy, we need to figure out what’s special about the different tumors and try to cure the tumors based on the unique features of the tumor biology.”
All participants will receive 12 weekly treatments with standard chemotherapy (Taxol alone or with Herceptin, depending on HER2 status) and 80 percent of patients will also receive one of a number of novel agents that target different molecular pathways affecting the growth and proliferation of tumors. That regimen is followed by four biweekly infusions of the standard drugs Adriamycin and Cytoxan. All patients receive standard of care chemotherapy and 80 percent also receive one of the novel targeted agents.
Tumor response is assessed from MRIs and core biopsies during the trial and from samples taken during surgery to remove any remaining tumor after chemotherapy is completed.
Specimens from all sites are handled through the same lab so one centralized computer system tracks and analyzes the data in real-time. Successful associations between patient biomarkers and tumor response among the early participants will influence which novel treatments subsequent trial participants receive.
“The overall goal is to see if we can predict which types of tumors will respond favorably to novel chemotherapy agents and use biomarkers to better predict response in patients,” Dr. Lang said.
As successful novel agents graduate from the study and ineffective ones are dropped, new drugs may be cycled in.
Typically it takes 12 to 15 years to evaluate one drug, but the goal of this trial is to evaluate 12 drugs in a five-year period, Dr. Lang said.
“It’s a really exciting trial,” she said. “I hope that we find a few drugs that will become standard of care for breast cancer, and I hope that we are able to individualize treatment for our patients based on the study results.”
All Arizona Cancer Center patients receive high-quality care from our National Cancer Institute-designated Comprehensive Cancer Center, Dr. Lang said, but patients enrolled in the I-SPY 2 study may have access to some of the most promising new drugs to pass Phase I trials and may enjoy additional benefits that come with clinical trial involvement.
“Many patients enjoy participation in clinical trials because they have a team of researchers, multidisciplinary physicians and research nurses looking after them,” she said. “They’re updated on their progress, and they have serial assessments of MRIs and biomarkers. The patients really feel like they’re involved in the search for the cure.”
Being one of the 20 sites nationwide to be able to offer this trial to patients demonstrates the fact that the Arizona Cancer Center is one of the leading sites in the country for the treatment of breast cancer patients, said Dr. Lang.
“Our patients have access to novel clinical trials, novel treatments and clinicians and investigators who have the ability to conduct trials of this scope,” she said. “Our center is able to ask important questions and strives to take on the challenge of improving the care of patients. I think that really distinguishes the Arizona Cancer Center.”
I-SPY 2 is managed by the Biomarkers Consortium, a unique public-private partnership led by the Foundation for the National Institutes of Health that includes the Food and Drug Administration, the National Institutes of Health, and a number of partners from major pharmaceutical companies, academic medical centers and non-profit and patient advocacy groups.
Safeway, Inc., one of the largest food and drug retailers in North America, is a significant funder of the study. The corporation will contribute a portion of proceeds from the Safeway Foundation’s annual chain-wide October Breast Cancer Awareness fundraising initiative to I-SPY 2. The Arizona Cancer Center has received $300,000 from the Safeway Foundation for I-SPY 2 participation.
“Our participation in this important national breast cancer drug study could not happen without support from the Safeway Foundation,” said Arizona Cancer Center Director David S. Alberts, MD. “We are especially pleased to be able to invest Safeway’s generous grant to conduct research with our patients here in Arizona.”
“This Foundation grant is part of our annual breast cancer fundraising effort,” said Dan Valenzuela, Safeway Phoenix Division president. “It is important to have money raised locally at Arizona’s 115 Safeway stores go to a local cancer center involved in cutting edge cancer research. The ultimate goal is to find a cure, and we are proud to partner with the Arizona Cancer Center.”
By Sarah Mauet