Phase 2 Trial of Selinexor (KPT-330) for Metastatic Triple Negative Breast Cancer (TNBC)

Inclusion Criteria

• •Histologically confirmed triple negative breast cancer (TNBC), defined as negative immunohistochemical staining for estrogen and progesterone receptors (≤5% of nuclei positive by IHC) and receptor tyrosine-protein kinase erbB-2 (HER2) negative (IHC 0-1+ or HER2-neu negative according to American Society of Clinical Oncology; College of American Pathologists (ASCO-CAP) HER2 Test Guideline Recommendations)
• •Written informed consent in accordance with federal, local, and institutional guidelines
• •Body surface area ≥1.4 m\^2
• •Age ≥18 years
• •Estimated life expectancy of \>3 months at study entry
• •TNBC must be either locally recurrent or metastatic. Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent.
• •Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• •Documented disease progression at study entry
• •Must have received at least 1 chemotherapy regimens in the setting of metastatic disease
• •Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
• •Adequate hematological function: Absolute neutrophil count (ANC) \> 1500/mm\^3, platelets count \>100,000mm\^3
• •Adequate hepatic function within 14 days prior to Cycle 1 Day 1 (C1D1): total bilirubin \<2 times the upper limit of normal (ULN) (except patients with Gilbert's syndrome who must have a total bilirubin of \< 3 times ULN) and aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5 x ULN. In the case of known (radiological and/or biopsy documented) liver metastasis, AST/ALT ≤5.0 times ULN is acceptable.
• •Amylase and lipase ≤ 1.5 x ULN
• •Adequate renal function within 14 days prior to C1D1: estimated creatinine clearance of ≥ 30 mL/min
• •Women of child-bearing potential (WOCBP) must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male participants must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. For both male and female participants, effective methods of contraception must be used throughout the study and for 3 months following the last dose. To be considered of non-childbearing potential, postmenopausal women must be amenorrheic for at least 12 months naturally (not in the setting of post chemotherapy) or participants must be surgically sterile.
• •Must have received prior anthracycline and taxane therapy unless clinically contraindicated