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Clinical Research & Trials

USO 20418

A RANDOMIZED PHASE 3 DOUBLE-BLINDED STUDY COMPARING THE EFFICACY AND SAFETY OF NIRAPARIB TO PLACEBO IN PARTICIPANTS WITH EITHER HER2-NEGATIVE BRCA-MUTATED OR TRIPLE-NEGATIVE BREAST CANCER WITH MOLECULAR DISEASE BASED ON PRESENCE OF CIRCULATING TUMOR DNA AFTER DEFINITIVE THERAPY (GSK 213831)

 

Disease Types: Breast Cancer Research

Eligibility Requirements:

- Stage I, II, or III triple negative or HR+/HER 2 (-) BRCA (+) breast cancer

- Must have completed initial curative therapy (chemotherapy, surgery, and/or radiation) and if HR+ been on stable endocrine therapy for 3 months

- No: prior treatment with PARP inhibitor (olaparib); current treatment with CDK 4/6 inhibitor (abemaciclib, palbociclib, ribociclib); endocrine therapy other than anastrozole, 

letrozole, exemestane, and tamoxifen; had no definitive response to pre-operative chemotherapy; condition that would affect ability to swallow or absorb oral medication;

current or active pneumonitis or history of pneumonitis requiring steroids within 90 days of planned start date; known history of MDS or AML; history of HIV, positive Hep B 

surface antigen, Hep B core antibody, or Hep C antibody. 

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