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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)
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 (ctDNA). Individuals who test positive for ctDNA 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.
What the Study Entails
- All eligible participants will be screened with a blood test for circulating tumor (ctDNA).
- People who completed treatment less than 12 months before participating and who test negative for ctDNA may receive up to 3 additional ctDNA blood tests. If all ctDNA tests are negative, they will not qualify for the intervention portion of the study.
- People who completed treatment more than a year prior to participating will receive one ctDNA blood test. If their ctDNA test is negative, they will not qualify for the intervention portion of the study.
- Participants whose blood test is positive for circulating tumor will be eligible for the intervention portion of the study.
- The intervention portion of the study has two groups. Participants will be randomly assigned to one of the two groups. Neither participants nor their doctors will know which group they have been assigned to.
- Group 1 will receive the oral niraparib.
- Group 2 will receive a .
- All participants in both groups will be followed with imaging every three months for any signs of clinical recurrence.
- Participants will be followed for up to 8 years.
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Principal Investigator: Edward H Kaplan
Additional sites are available in the following countries:
- South Africa
- United Kingdom
People age 18 years or older who meet the following criteria are eligible for ctDNA screening:
- diagnosed with I to III breast cancer that is either: 1) or 2) HR+/HER2- breast cancer with a or mutation.
- have completed prior therapy with intent to cure, including: surgery, radiation, chemotherapy (patients with a mutation who are still on hormonal therapy may still be eligible).
Participants who meet the above criteria and who have detectable circulating tumor in their blood may be eligible to participate in the treatment portion of the study.
People who have the following, are not eligible to participate:
- have had prior treatment with a .
- are currently being treated with a CDK 4/6 inhibitor.
- have disease or locally recurrent cancer.
- have shown no response to preoperative chemotherapy.
- have a second primary cancer (contact the study team for a list of exceptions).