A RANDOMIZED PHASE 3 DOUBLE-BLINDED STUDY COMPARING THE EFFICACY AND SAFETY OF NIRAPARIB TO PLACEBO IN PARTICIPANTS WITH EITHER HER2-NEGATIVE BRCA-MUTATED OR TRIPLE-NEGATIVE BREAST CANCER WITH MOLECULAR DISEASE BASED ON PRESENCE OF CIRCULATING TUMOR DNA AFTER DEFINITIVE THERAPY (ZEST)
Study of Niraparib in Patients Who Have Been Previously Treated for Breast Cancer
Sponsor: GlaxoSmithKline
Enrolling: Male and Female Patients
IRB Number: AAAT9059
U.S. Govt. ID: NCT04915755
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: The purpose of this study is to evaluate if the study drug, niraparib will help patients delay or prevent their breast cancer from returning. This study will compare niraparib to placebo in study participants who have been treated for breast cancer and were then found to have breast cancer ctDNA (Circulating tumor DNA (ctDNA) is found in the bloodstream and refers to DNA that comes from cancerous cells and tumors) in their blood. Niraparib is a tablet that is taken once a day. A placebo, or sugar tablet, is a tablet that is made to look like the active drug but does not have the active ingredient in it. Researchers use a placebo to see if the study drug works better than not taking anything.
Investigator
Julia McGuinness, MD
Do You Qualify?
Are you at least 18 years old? Yes No
Have you received prior treatment for breast cancer? Yes No
Are you able to swallow pills? Yes No
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For more information, please contact:
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162