Current Clinical Trials

BRE12-158: A Treatment Trial for Triple Negative Breast Cancer

Dr. Bryan P. SchneiderDr. Bryan P. Schneider, Principal Investigator
What is the goal of this study?

The goal of this study is to try to match an FDA approved drug with your tumor’s DNA and RNA abnormalities. These abnormalities are what cause cancer to develop and grow.

Is this trial right for me?

Talk to your doctor about your treatment options.

For this trial you must:

  • Have non-metastatic triple negative (ER-/PR-/HER2-) breast cancer, stage I-III
  • Have completed preoperative (neoadjuvant) chemotherapy
  • Have had surgery to remove the breast cancer*
  • 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.

What is genomic therapy?

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.

What should I know about the treatment?

If you choose to be in this trial and meet all requirements, you will be randomized to one of two treatment groups. Randomization means that patients are assigned to a group by chance: You will have equal chance of being in either group. Neither you nor your doctor can choose the group you will be in.

  • Group A (directed therapy) participants

    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

    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.

What are the costs?

You and/or your insurance company will be charged for costs associated with care that is considered routine for someone with breast cancer. You will also be responsible for co-payments and deductibles that are typical for your insurance provider. Check your health plan to find out what is covered. The genomic targeted drugs will be provided to you free of cost while you take part in this study. Costs for testing done specifically for this study will be covered by a grant.

Where is this trial being conducted?

This trial is being conducted at the IU Simon Cancer Center and at selected sites around the country.

Map of cities where trial is being conducted

For a list of other participating sites, please see the Hoosier Cancer Research Network.

Are you interested in participating?

If you think you are eligible and interested in participating, complete the survey below and speak with your doctor.

Survey: https://is.gd/ParticipateBRE12_158

For more information or questions contact:

Casey Bales, CCRP
Phone: 317-274-2840
calallen@iupui.edu