This research is studying the effect of Antibody-Drug Conjugate Sacituzumab Govitecan in
Combination with the Poly (Adenosine Diphosphate [ADP]-Ribose) Polymerase (PARP) Inhibitor
Talazoparib in Patients with Metastatic Triple-Negative Breast Cancer.
This is a Phase I/II clinical trial. You are being asked to participate in the Phase I
portion of the study. A Phase I clinical trial tests the safety of an investigational drug
and also tries to define the appropriate dose of the investigational drug to use for further
studies. "Investigational" means that the drug is being studied.
The U.S. Food and Drug Administration (FDA) has not approved sacituzumab govitecan as a
treatment for any disease.
The FDA has not approved talazoparib for this specific disease, but it has been approved for
other uses in breast cancer.
Sacituzumab govitecan is an antibody-drug conjugate which means it's made up of an antibody
attached to an anticancer drug. An antibody is a protein normally made by the immune system
(the system in the body that fights off diseases). Sacituzumab govitecan is believed to work
by binding the antibody portion of the drug to the tumor(s) while the anticancer drug portion
works to prevent the cancer cells from growing/spreading.
Talazoparib belongs to a group of drugs called PARP inhibitors. PARP is a protein that is
involved with repairing damaged DNA (the genetic material of cells). Talazoparib is believed
to work by inhibiting (stopping) the PARP proteins from working in the cancer cells so that
the cancer cannot fix its damaged DNA.
The investigators believe that the combination of sacituzumab govitecan and talazoparib may
help stop the cancer from growing and spreading by administering an anticancer drug directly
to the cancerous tumor(s) through sacituzumab govitecan and by stopping the cancer's cells
from fixing its damaged DNA through talazoparib.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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