Breast cancer is not a single disease but a cluster of diseases, each with its own characteristics that allow it to survive and thrive. While advances have been made in understanding the nuances of each sub-type, standard treatment remains more or less the same: resect the cancer with surgery and infuse the patient with toxic drugs that kill healthy cells along with the cancerous ones. It is an imprecise approach at a time when precision is demanded.
Members of the Vera Bradley Foundation Center for Breast Cancer Research know that to improve results for women with breast cancer, they must design therapies that consider the unique traits of the tumor and the woman it has invaded. Combining this information yields therapies tailored to each patient– precision therapeutics that are best tolerated by the patient and that precisely target her tumor.
At the Vera Bradley Foundation Center, investigators refer to this approach as Monogrammed Medicine.
Monogrammed Medicine is another term for personalized medicine or precision health. The aim of this approach is to take into account individual variables in genes, environment and lifestyle when developing prevention and treatment strategies. This is in contrast to the one-size-fits all approach that has been relied upon for decades. In the case of breast cancer, the goal of personalized medicine is to deliver the right therapy to the right person at the right size.
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.