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A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Multi-Center Phase III Study to Assess the Efficacy and Safety of Olaparib vs Placebo as Adjuvant Treatment in Patients with Germline BRCA 1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy

Study Summary

  • This study aims to look at the effects of Olaparib on BRCA positive breast cancer patients. Patients must also be:
    • HER2 negative
    • Completed their first line treatment, whether it is neoadjuvant or adjuvant chemotherapy, radiation or surgery.
  • After determining patient eligibility, patient will be randomized 1:1, like the flip of a coin, to receive either Olaparib or placebo for 12 months
  • The patient will take either Olaparib or placebo (we won’t know) 2 times a day for 12 months

Protocol

  • NSABP B55

Phase

  • III

Investigator

  • Dr. Kenneth Blankstein

Disease

  • Breast Cancers with a BRCA 1 or 2 mutation

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Inclusion

  • Patient must be BRCA positive and HER2 negative
  • Recently completed treatment course with either chemotherapy, radiation therapy or surgery

Exclusion

  • Any previous treatment with a PARP inhibitor, including olaparib and/or known hypersensitivity to any of the excipients of study treatment.
  • Patients with second primary malignancy. EXCEPTIONS are:
    • Adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, Ductal Carcinoma in situ (DCIS) of the breast, stage 1 grade 1 endometrial carcinoma
    • Other solid tumors and lymphomas (without bone marrow involvement) diagnosed ≥ 5 years prior to randomization and treated with no evidence of disease recurrence and for whom no more than one line of chemotherapy was applied.
  • Concomitant use of known potent CYP3A inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir
  • Cannot by Stage IV/metastatic breast cancer

 


If you have any questions regarding this study or think that
you or your loved one may be eligible, please feel free to contact:

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