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Trial of Genomically Directed Therapy After Preoperative Chemotherapy in Patients with Triple Negative Breast Cancer
||A Phase II Randomized Controlled Trial of Genomically Directed Therapy After Preoperative Chemotherapy in Patients with Triple Negative Breast Cancer
||John Erban, MD
The purpose of this study is to test the theory that therapy designed for each individual’s tumor will improve outcomes over standard of care in a population that needs a better standard. Using tumor tissue samples from a prior surgery, treatment reccomendations will be made based on DNA sequencing of the tumor cells by a Cancer Genomics Tumor Board facilitated by the Hoosier Cancer Research Network. Subjects will be randomized to one of several treatment options based on their specific tumor genetic make-up, prior treatment history and tolerance, and medical history.
- Must have confirmed triple negative (ER-/PR-/HER2-) invasive breast cancer
- Must have completed preoperative (neoadjuvant) chemotherapy
- Must have had surgery on the primary tumor
- Must not have an active second malignancy
- Must not have an active infection
- Must not be pregnant or nursing
Subjects must come to clinic to sign consent for a smaple of their tumor tissue to be sent for tumor and for typical lab tests and exams used to treat breast cancer. After treatment has been assigned subjects will come into clinic and be asked to sign a treatment specific consent form. Subjects will be asked to come in according to the specific treatment schedules and lab tests ande exams will be preformed as well as an extra blood sample (about half a teaspoon) on the first day of each treatment cycle for research. If subjects have signed an optional consent form, extra blood samples will also be taken on the first day of each treatment totaling about half a table spoon.