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    Association details:
    Biomarker:BRCA1 mutation
    Cancer:Ovarian Cancer
    Drug:Talzenna (talazoparib) (PARP inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C1 - Off-label
      (Approved for HER2 Negative Breast Cancer)
    New
    Title:

    Regulator OKs Pfizer's BRCA mutation breast cancer treatment

    Excerpt:
    Pfizer Korea said that the Ministry of Food and Drug Safety has approved Talzenna, its BRCA (Breast Cancer Susceptibility Gene) mutation breast cancer targeted therapy....treatment as monotherapy for germline BRCA (gBRCA) mutations and HER2 (human epithelial cell growth factor receptor 2) negative locally advanced or metastatic breast cancer patients have previously had chemotherapy.
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors

    Excerpt:
    ...Breast and ovarian cancer patients with deleterious or pathogenic BRCA mutations who have received no more than 4 prior regimens for metastatic disease...
    Trial ID:
    NCT01286987
    Evidence Level:
    Sensitive: C3 – Early Trials
    New
    Source:
    Cancer Discov
    Title:

    Phase I, Dose-Escalation, Two-Part Trial of the PARP Inhibitor Talazoparib in Patients with Advanced Germline BRCA1/2 Mutations and Selected Sporadic Cancers

    Excerpt:
    We evaluated talazoparib therapy in this two-part, phase I, first-in-human trial...At 1.0 mg/day, confirmed responses were observed in 7 of 14 (50%) and 5 of 12 (42%) patients with BRCA mutation– associated breast and ovarian cancers, respectively, and in patients with pancreatic and small cell lung cancer.
    DOI:
    10.1158/2159-8290.CD-16-1250
    Trial ID:
    NCT01286987