Current Clinical Trials
Drs. Bryan Schneider, Anna Maria Storniolo, and Kathy Miller joined with colleagues at the Fox Chase Cancer Center to conduct two clinical trials evaluating novel immunotherapies in patients with aggressive breast cancer. These trials incorporate evaluation of biomarkers to identify who benefits from this important therapy.
Dr. Miller is also testing two chemotherapy agents in women with Triple-Negative Breast Cancer and a high risk of recurrence. The trial includes a specific biomarker likely to predict which chemotherapy will be the most effective for individual patients.
BRE12-158: A Treatment Trial for Triple Negative Breast Cancer
The goal of this study is to try to match an FDA-approved drug with the tumor’s DNA and RNA abnormalities. These abnormalities are what cause cancer to develop and grow.
To participate in this trial, a participant must have non-metastatic triple negative (ER-/PR-/HER2-) breast cancer, stage I-III and completed preoperative (neo-adjuvant) chemotherapy. Qualified participants have had surgery to remove the breast cancer* and have disease remaining after receiving chemotherapy and surgery.
Participants must register within 84 days of surgery (for those participants who do not require radiation) or within 84 days of completion of radiation when radiation is required.
Frequently Asked Questions
Traditional chemotherapy targets all dividing cells, causing cell death to even non-cancerous cells. Drugs labeled as targeted therapies interfere with specific proteins or molecules that are required for continued growth and function of tumor cells. The goal of targeted therapies is to reduce side effects and deliver a more direct therapy to the tumor cells.
If chosen to be in this trial after meeting all requirements, the participant will be randomized to one of two treatment groups. Randomization means that participants are assigned to a group by chance. Neither the participant nor the doctor can choose the group.
Group A (directed therapy) participants will receive an FDA-approved drug. The FDA has approved these drugs but not necessarily for cancer. This therapy will be given for 12-16 weeks depending on the drug and will be given according to the FDA approved label.
Group B (standard approach) participants will be treated using the standard approach as determined by their treating physician. Currently the standard approach for treatment varies greatly and may include additional therapy or routine follow-up without any additional therapy.
The participant and/ or their insurance company will be charged for costs associated with care that is considered routine for someone with breast cancer. Each participant will also be responsible for co-payments and deductibles that are typical of their insurance provider. Participants should check their health plan to find out what is covered. The genomic targeted drugs will be provided for free of cost while participants take part in this study. Costs for testing done specifically for this study will be covered by a grant.
This trial is being conducted at the IU Simon Cancer Center and at selected sites around the country. A list of other participating sites are available through the Hoosier Cancer Research Network.