Get notified of page updates
Enroll in Research > Research Search & Enroll Tool > 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)
Printer Friendly Page 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)

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. 

This Study is Open To:

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. 

This Study is Not Open To:

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).