Screening for Cancer DNA in the Blood after Treatment for Early-Stage TNBC and/or a BRCA Mutation; Followed by Study Comparing Niraparib with Placebo for People with Cancer DNA found in their Blood (ZEST)
Clinicaltrials.gov identifier:
NCT04915755
Early-stage TNBC or early-stage breast cancer with a BRCA mutation
Study Contact Information:
Contact: US GSK Clinical Trials Call Center at: 877-379-3718 or by email at: [email protected]
Using ctDNA Blood Test to Screen for Cancer DNA after Treatment for Early-Stage TNBC and/or an Inherited or Tumor BRCA Mutation; Followed by Study Comparing Niraparib with Placebo for People with Cancer DNA found in their Blood (ZEST)
About the Study
The ZEST study has two parts, a screening portion that will look for evidence of cancer cell in the bloodstream, and an intervention portion that is open to people who test positive for cancer cell in their bloodstream.
ZEST will enroll people with triple negative breast cancer or people with an inherited or acquired or mutation who have completed treatment (or are still in treatment with hormone therapy) for monitoring using a blood test known as circulating tumor (). Individuals who test positive for will be able to participate in a study to receive the , or a and undergo close monitoring with imaging (CT scans). The study will look at the safety and efficacy of plus monitoring compared with plus monitoring for people who test positive for cancer cells in their blood but who have no evidence of cancer recurrence.
Currently, monitoring for circulating tumor in people who have completed treatment for breast cancer is not standard-of-care. For this reason there is currently no standard-of-care treatment recommendations for people who test positive for circulating tumor in the absence of other signs of recurrence. Note: This study is no longer enrolling.
NOTE: This study is closed.
NOTE: This study is closed.