Parsaclisib in Newly Diagnosed Stage I-IIIC Triple Negative or HER2+ Breast Cancer
Status:
Withdrawn
Trial end date:
2020-09-07
Target enrollment:
Participant gender:
Summary
The purpose of this research study is to find the lowest dose of the cancer drug parsaclisib
that has an effect on the type of breast cancer a participant has. Researchers are looking at
how Parsaclisib affects the immune system. They want to learn whether and how it helps the
immune system to find cancer cells to fight them.
Parsaclisib is an oral drug that limits the effects of a protein called phosphatidylinositol
3-kinase δ (PI3K). By limiting P13K, parsaclisib can block certain cells that prevent the
immune cells from working. As a result, it may help the body's immune system to fight tumors.
Parsaclisib is being studied in several clinical trials to treat different types of cancers.
Parsaclisib has not yet been approved by FDA for the treatment of cancer.
Studies have shown that a good way to find out how cancer acts when exposed to anti-cancer
drugs is through a pre-operative window study. In this type of study, tissue and blood are
collected before treatment. Then subjects receive a study drug for a few weeks before
surgery. Blood is drawn during the course of treatment, and leftover tissue is collected
during surgery. Comparing the tissue and blood before and after treatment shows the effects
the study drug may have had on the tumor.
Research shows that cancers differ when you look at the DNA and RNA (genetic codes) that are
inside a cancer cell. DNA and RNA carry genetic information that can determine traits in
humans (such as eye color, height, reaction to treatment, etc.), as well as the traits of
cancer cells. Depending on the genetic profile (particularly DNA and RNA) of the cancer, it
may respond differently to parsaclisib. In this study, the investigators will look at the
genetic profile of a participant's tumor by studying tissue and blood samples collected
before and after receiving treatment.