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Breast Cancer Trial May Change Standard of Care


A study which stands to change the standard


of care and improve outcomes for scores of women affected by breast cancer recently launched at Sylvester. Led by Mark Pegram, M.D., and Joyce Slingerland, M.D., Ph.D., both of the Braman Family Breast Cancer Institute at Sylvester, the study was prompted by findings of a phase 1 trial with stage 4 breast cancer patients who failed conventional treatment. The trial determined the combination of saracatinib (AZD0530), a src kinase inhibitor, and Arimidex (FDA-approved for patients with ER-positive breast cancer), is safe and well tolerated. The study builds on Dr. Slingerland’s research which indicates that by inhibiting src, patients have a better response to treatment when using anti-estrogen treatments combined with saracatinib. The next step in saracatinib’s FDA approval process is this phase 2 randomized trial to test safety and effectiveness, using the same combination. The trial is recruiting newly diagnosed, post-menopausal women who


are ER-positive. Two-thirds of patients will receive combination treatment, while the other third receives standard therapy (anti-estrogen therapy alone). After 4-6 months on treatment, a lumpectomy will be performed for molecular analysis to measure and gauge activation of aberrant signaling pathways caused by the cancer-associated gene, src. The tumor’s size also will be evaluated using the latest MRI technology. The goal is to identify greater tumor shrinkage in women treated with combination. Results of this phase 2 trial may indicate the ability to overcome resistance to conventional therapy to make available treatments more effective.


A new Phase I clinical trial for pediatric patients with leukemia or lymphoma is underway at Sylvester in collaboration with the Thera- peutic Advances in Childhood Leukemia and Lymphoma Consortium (TACL) and drug manufacturer Novartis. John Goldberg, M.D., director of the Pediatric Early Phase Clinical Trials Program, is the principal investigator and the national study chair for this trial, which opened in August. Listed on clinicaltrials.gov (number NCT01321346), this study using Panobinostat in refractory hematological malignancies aims to recruit 36 patients nationwide between 8 and 21 years old who have relapsed after treatment. The trial is based on research by Julio Barredo, M.D.,


Dr. Mark Pegram


For more information about trials for pediatric patients, contact Myriam Zayas, R.N., at 305-243-7846 or mzayas@med.miami.edu.


director of Pediatric Hematology-Oncology and Children’s Cancer Programs at Sylvester. The expected duration of the study is two years. Panobinostat is a potent HDAC inhibitor, which is not


yet FDA approved. It interferes with gene expression found in tumor cells, causing them to stop growing or die. The drug has shown promising results in Phase 3 testing in adults, and this is the first time it is being tested in children. “Our trial may bring an exciting new medication


into our armamentarium against childhood cancer. HDAC inhibitors form the backbone of future combina- tion therapies for cancer. The faster we study these drugs in kids, the faster we will be able to use them to help people,” said Dr. Goldberg.


THE MAGAZINE OF SYLVESTER COMPREHENSIVE CANCER CENTER 23


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