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Olaparib Plus DNA Damage Repair Targeted Therapy for Metastatic TNBC

Clinicaltrials.gov identifier:
NCT03330847

Treatment

Study Contact Information:

Contact: AstraZeneca Clinical Study Information Center by email or phone: 1-877-240-9479.

 


Safety and Efficacy of Olaparib Alone Or in Combination with Medication Targeting DNA Damaging Repair for Metastatic Triple Negative Breast Cancer

About the Study

The purpose of this study is to learn the safety and effectiveness of the , as a single drug therapy compared with  in combination with the new agent AZD6738 in patients with Triple-Negative Breast Cancer ().  NOTE: This study is no longer enrolling people. 

Type of Study

This is a , two-arm, open label study.  

  • This is a  study, which means that participants will be placed into one of the two treatment groups by chance. Neither patients nor the research doctor will choose the group participants are placed in. 
  • The study has two arms. This means that patients in the study are placed in one of two different groups. One group will received the  olaparib only and the other group will receive and AZD6738. 
  • The study is . All participating patients will know which group they have been assigned to. 

Participants will have tumor testing to look for mutations in genes that called " repair" (HRR) pathway genes. Participants will be divided into three groups based on their tumor results:

  • Group A: Patients with or gene mutations
  • Group B: Patients with mutations in any of the other genes involved in the HRR pathway, and no mutation in and no mutation in
  • Group C: Patients with no detected tumor mutations in any of the HRR genes

What the Study Entails

Eligible patients will be randomly placed in one of two treatment arms:

  • Arm 1: Participants will take oral twice daily in a 28-day cycle
  • Arm 2: Participants will take oral  twice daily in a 28-day cycle and on days 1-7, participants will also take AZD6738 orally daily.

Participants will stay on the study until they have progression of their cancer or an that requires them to end their participation. Participants will be followed for up to 24 months. 

Study Sites: 

NOTE: Additional study sites can be found on clinicaltrials.gov.

For information about participating at all sites, contact AstraZeneca Clinical Study Information Center by email or phone: 1-877-240-9479.

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

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 people. 

This Study is Not Open To: