A Phase II Randomized Controlled Trial Of Genomically Directed Therapy After Preoperative Chemotherapy In Patients With Triple Negative Breast Cancer
Posted Date: Jun 20, 2018
- Investigator: Neetu Radhakrishnan
- Specialties: Breast Cancer, Cancer
- Type of Study: Drug
The purpose of this study is to compare any good and bad effects of using a Food and Drug Administration (FDA)-approved drug selected based on the identification of genetic differences in your tumor to being treated using the standard approach. The standard approach may be surveillance, or additional chemotherapy, as deemed appropriate by your treating physician, and amount of residual disease after chemotherapy. DNA is a record of instructions telling your cells what their job will be such as determining eye color or hair color. RNA helps get the instructions to the cells from the DNA. This study includes extracting your tumor’s DNA and RNA and then performing “next generation sequencing” testing. Next generation sequencing is a new way to look at abnormalities and differences in the DNA/RNA obtained from your tumor. A goal of this study is to try to specifically match an FDA-approved drug with your tumor’s DNA/RNA abnormalities. This is called “directed” therapy. In this study, half the participants will receive directed therapy and half will follow the standard approach, as determined by their treating physician. If an FDA-approved drug cannot be successfully matched to your tumor, you will be assigned to the standard approach group. While approved by the FDA, the study drugs may not be approved to treat cancer. Finally, we will test whether those who receive this directed therapy have better outcomes than those who follow a standard approach, as determined by their treating physician. The drugs used in the study are FDA-approved for certain indications. The drug selected will be used differently than indicated by FDA-approval.
You Are Being Asked To Take Part In This Research Study Because You Are At Least 18 Years Of Age And Have Been Diagnosed With Triple Negative Breast Cancer And Have Significant Residual Disease After Being Treated With Chemotherapy And Surgery.
Targetted Therapy, Triple Negative Breast Cancer, Poor Response To Neoadjuvant Therapy, Adjuvant Therapy, Molecular Markers
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