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
Treatment
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.
What the Study Entails
- All eligible participants will be screened with a blood test for circulating tumor ().
- People who completed treatment less than 12 months before participating and who test negative for may receive up to 3 additional blood tests. If all 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 blood test. If their 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.
Study Locations
For all sites, the study contact is: [email protected] or by phone: 877-379-3718
California
- Burbank
Roy and Patricia Disney Family Cancer Center
Erwin Grussie, MD - Duarte
City of Hope
Daphne Stewart, MD - Orange
Providence St. Joseph Hospital-Orange
Timothy Byun, MD - Palo Alto
Stanford Cancer Center
Melinda Telli, MD
Colorado
- Aurora
University of Colorado Medicine
Marie Wood, MD
Illinois
- Chicago
Rush Medical Center
Lydia Usha, MD - Skokie
Hematology Oncology of the North Shore
Edward Kaplan, MD
Michigan
- Ann Arbor
University of Michigan Rogel Cancer Center
Monika Burness, MD
New Mexico
- Albuquerque
University of New Mexico Comprehensive Cancer Center
Jackie Marie Nemunaitis, MD
New York
- New York City
Columbia University Herbert Irving Comprehensitve Cancer Center
Julia McGuinness, MD
North Dakota
- Fargo
Sanford Health
Anu Gaba, Md
Pennsylvania
- Philadelphia
Fox Chase Cancer Center
Angela Jain, MD - Pittsburgh
University of Pittsburgh Medical Center Hillman Cancer Center
Adam M. Brufsky, MD
South Dakota
- Sioux Falls
Sanford Health
Christopher Sumey, MD
Texas
- Austin
Texas Oncology
Debra Patt, MD - Dallas
Texas Oncology
Kristi McIntyre, MD - Dallas
Texas Oncology
Joyce A. Oshaughnessy, MD - Fort Worth
Texas Oncology
Chi M Pham, MD - Houston
Texas Oncology
Michelina Cairo, MD - San Antonio
Texas Oncology
Emmalind Aponte - Tyler
Texas Oncology
Donald A. Richards, MD
Virginia
- Norfolk
Virginia Oncology Associates
Michael Danso, MD
Washington
- Everett
The Everett Clinic
Ajay Kundra, MD
Additional sites are available in the following countries:
- Argentina
- Australia
- Austria
- Belgium
- Brazil
- Canada
- Ontario
- Quebec
- Chile
- Finland
- France
- Germany
- Ireland
- Israel
- Italy
- Japan
- Mexico
- Netherlands
- Norway
- Poland
- Portugal
- Romania
- Russia
- South Africa
- Spain
- Switzerland
- United Kingdom
See Clinicaltrials.gov for the full list of study sites or call the study contact for more information.
People age 18 years or older who meet the following criteria are eligible for 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).
- have enough tissue left over from previous biopsies for tumor marker testing.
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).