OPHELIA

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The OPHELIA study is a multicenter, open-label, single-arm, two cohorts, Simon’s Two-Stage minimax design, phase II clinical trial.

The primary objective of this trial is to assess the efficacy – as determined by the Overall Response Rate (ORR) and Progression-free Survival (PFS) based on RECIST v.1.1 – of olaparib in combination with trastuzumab in patients with HER2-positive, germinal BRCA1/2 mutated ABC.

NAME TUMOR TYPE TITLE PHASE N SITES COUNTRY STATUS
OPHELIA
Breast Effectiveness of olaparib plus trastuzumab in HER2-positive BRCA-mutated or Homologous Recombination Deficiency (HRD) advanced breast cancer patients. II 33
(7 in the first stage; 26 in the second stage)
18 Spain Set-up