['neoplasms, breast', 'carcinoma of breast', 'human epidermal growth factor 2 negative carcinoma of breast', 'brca1 gene mutation', 'brca2 gene mutation', 'ovarian neoplasms']
['niraparib', "physician's choice"]

        Inclusion Criteria:

          1. Germline BRCA1 or BRCA2 mutation; patients with unknown BRCA status who meet NCCN BRCA
             screening criteria will be screened for BRCA mutation.

          2. Histologically or cytologically confirmed HER2-negative metastatic or locally advanced
             disease that is not amenable to resection or radiation with curative intent.

          3. Up to 2 prior cytotoxic regimens for advanced or metastatic breast cancer; patients
             with no prior cytotoxic regimens for advanced or metastatic disease will only be
             allowed if they relapsed during or within 12 months of (neo-) adjuvant cytotoxic
             therapy.

          4. Prior therapy should have included a taxane and/or anthracycline (unless
             contraindication to those) in the neoadjuvant, adjuvant, or advanced/metastatic
             setting.

             a. Hormone receptor positive patients must also have hormone resistant disease; either
             relapsed while on adjuvant endocrine treatment, or within one year of completing
             adjuvant endocrine treatment, or progression on at least one line of endocrine
             treatment for advanced cancer.

          5. ECOG performance status 0-2

          6. Adequate bone marrow, kidney and liver function

        Exclusion Criteria:

          1. Patients with platinum resistant cancer

          2. Symptomatic uncontrolled brain metastases

          3. Prior diagnosis of Stage IV ovarian cancer; Stage III ovarian cancer must have a
             5-year disease-free interval; Stage II ovarian cancer must have a 2-year disease-free
             interval

          4. Known hypersensitivity to the components of niraparib

          5. Invasive cancer other than breast cancer within 2 years (except basal or squamous cell
             carcinoma of the skin that has been definitely treated)

          6. Pregnant or breast feeding patients

          7. Immunocompromised patients

          8. Known active Hepatitis B or C

          9. Prior treatment with a PARP inhibitor

         10. Known history of myelodysplastic syndrome (MDS).

         11. known and persistent (>4 weeks) >/= grade 3 toxicity or fatigue from prior cancer
             treatment.
      