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Safety and Efficacy of Olaparib Combined with Agents Targeting DNA Damage Repair Compared to Olaparib Alone

https://www.facingourrisk.org/research-clinical-trials/study/104/olaparib-combined-with-agents-targeting-dna-damage-repair-compared-to-olaparib-alone

Clinicaltrials.gov identifier:
NCT03330847 (https://clinicaltrials.gov/show/NCT03330847)


Study Contact Information:

Contact AstraZeneca Clinical Study Information Center by phone: 877-240-9479 or email


NOTE: This study is no longer enrolling patients. 

About the Study

The purpose of this study is to assess the efficacy and safety of treatment with the PARP inhibitor, olaparib combined with the drug Ceralasertib compared with olaparib alone for patients with Triple-Negative Breast Cancer.

The study outcomes will be analyzed for the following three patient populations:

  1. Patients with BRCA1 or BRCA2 gene mutations.
  2. Patients with mutations in any of the other genes, and no mutation in BRCA1 and no mutation in BRCA2.
  3. Patients with no detected tumor mutations in any of the homologous recombination repair (HRR) genes. Homologous recombination is a method that normal cells use to repair damage to DNA.

Type of Study

This is an open label, randomized, two-arm study that will enroll 350 people. 

What the Study Entails

Eligible patients will be randomized into one of two treatment arms:

Patients will remain on the study until date of first documented progression of disease or an adverse event that keeps the participant from continuing on the study. 

Study Locations

State City
Alaska Anchorage
Arizona Gilbert
California Palm Springs
Colorado Aurora
Connecticut New Haven
Georgia Marietta
Illinois Chicago
Indiana Munster
Kentucky Hazard
Louisville
Maryland Baltimore
Bethesda
Missouri Kansas City
New Jersey Brick
New York East Setauket
Lake Success
Mineola
Mount Kisco
Stony Brook
Ohio Cincinnati
Kettering
Oregon Corvallis
Tenessee Knoxville
Texas Dallas
Washington Olympia
Seattle

Sites are also open in Canada and the United Kingdom. 

Principal Investigator

Andrew Tutt, MB ChB PhD
Guy's Hospital, Great Maze Pond, London


This Study is Open To:

NOTE: This study is no longer enrolling patients. 

This Study is Not Open To:

Patients will be excluded if they:


About FORCE

FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.