A Phase II Open-Label, Randomized Study of PARP Inhibition (olaparib) Either Alone or in Combination with Anti-PD-L1 Therapy (atezolizumab; MPDL3280A) in Homologous DNA Repair (HDR) Deficient, Locally Advanced or Metastatic Non-HER2-positive Breast Cancer
Olaparib With or Without Atezolizumab in Treating Patients With Locally Advanced or Metastatic Non-HER2-Positive Breast Cancer
Sponsor: National Cancer Institute NCI
Enrolling: Male and Female Patients
IRB Number: AAAS0582
U.S. Govt. ID: NCT02849496
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: The purpose of this study is to compare any good and bad effects of using olaparib and atezolizumab in combination compared to olaparib alone. The use of olaparib alone or in combination with atezolizumab could shrink your cancer but could also cause side effects. This study will allow the researchers to know whether the combination approach is better, the same, or worse than olaparib alone. To be considered better, the study drug combination should increase the amount of time that a persons cancer does not grow by at least 5 months compared to the single drug approach. Olaparib has been approved by the United States Food and Drug Administration (FDA) for treatment of certain kinds of ovarian and breast cancers. Atezolizumab has been approved by the FDA for treatment of urothelial and certain kinds of lung cancer, but is not approved by the FDA for treatment of breast cancer. There will be about 72 people taking part in this study.
This study is closed
Meghna Trivedi, MD
Do You Qualify?
Are you 18 years of age or older? Yes No
Do you have locally advanced or metastatic HER2-negative breast cancer and a known BRCA 1/2 mutation present? Yes No
Is your life expectancy greater than 6 months? Yes No
You may be eligible for this study

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