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Title:
10020 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
Protocol Number:
ETCTN10020
Phase:
Phase II
Physician:
Roisin Connolly
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
The purpose of this study is to compare any good and bad effects of using ABT-888 and atezolizumab in combination compared to either study drug alone.
Eligibility:
Patients with BRCA-Mutated Triple Negative Breast Cancer which has not responded to treatment may be eligible.
Treatment:
This study has three study groups: • Group 1 will receive the study drug ABT-888 by mouth, twice daily. • Group 2 will receive the study drug atezolizumab by vein, once every 3 weeks at the center. • Group 3 will receive both study drugs, ABT-888 and atezolizumab, in combination.A computer will by chance assign you to treatment groups in the study. This is called randomization. This is done by chance because no one knows if one study group is better or worse than the other.For patients randomized to Group 1 or Group 2 ONLY: Should your disease progress or get worse while being treated on either Group 1 (ABT-888 alone) or Group 2 (atezolizumab alone), and if you remain eligible, you may choose to receive the combination therapy.You will receive the study drugs for as long as the study drug(s) appear to be benefiting you and you are not having any unacceptable side effects. After you finish the study drug(s), your doctor will continue to watch you for side effects and follow your condition for at least 30 days. If you stopped taking the study drug(s) because of unacceptable side effects, your doctor may need to follow up with until your side effects have been resolved.
Population:
Adult
Last Update
03/05/2019 05:03 AM