BKM120 For Triple Negative Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: BKM120
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic; Triple Negative

Summary:

      Triple negative breast cancer (TNBC) has an aggressive phenotype and poor prognosis. This
      tumor type characterized by lack of expression of estrogen receptor (ER), progesterone
      receptor (PR) and no amplification of the human epidermal growth factor 2 (HER2) accounts for
      15% of breast cancers. Limited treatment options exist in the clinic as hormonal therapies
      and HER2-trageted agents have proven ineffective. BKM120 is a drug that works by blocking a
      protein called phosphatidylinositol-3-kinase (PI3K) which may contribute to cancer growth.
      This drug has been used in experiments in the laboratory and information from these research
      studies suggests that BKM120 may help to prevent cancer cells from growing. In this research
      study, the investigators are looking to see if BKM120 works to stop breast cancer cells from
      growing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically and radiologically confirmed metastatic triple negative breast cancer

          -  Up to two prior lines of chemotherapy for metastatic breast cancer

          -  Availability of a representative tumor specimen

          -  At least one measurable lesion

        Exclusion Criteria:

          -  Have received previous treatment with PI3K inhibitors

          -  Symptomatic central nervous system (CNS) metastases (controlled and asymptomatic CNS
             metastases are acceptable)

          -  Concurrent malignancy or has a malignancy within 3 years of study enrollment

          -  Any of the following mood disorders: active major depressive episode, bipolar
             disorder, obsessive-compulsive disorder, schizophrenia, history of suicidal attempt or
             ideation, homicidal ideation, greater than or equal to Common Toxicity Criteria for
             Adverse Events (CTCAE) grade 3 anxiety

          -  Concurrently using other approved or investigational antineoplastic agent and/or
             chemotherapy within 21 days prior to enrollment in this study

          -  Has received radiation therapy within 28 days prior to enrollment in this study or has
             not recovered from side effects of such therapy

          -  Major surgery within 28 days of starting therapy or has not recovered from major side
             effects of a previous surgery

          -  Poorly controlled diabetes mellitus

          -  History of cardiac dysfunction

          -  Currently receiving treatment with QT prolonging medication and the treatment cannot
             be discontinued or switched to a different medication

          -  Impairment of gastrointestinal (GI) function or GI disease that may significantly
             alter the absorption of BKM120

          -  Receiving chronic treatment with steroids or another immunosuppressive agent

          -  Other concurrent severe and/or uncontrolled medical condition that would
             contraindicate participation in this study

          -  History of non-compliance to a medical regimen

          -  Currently being treated with drugs known to be moderate or strong inhibitors or
             inducers of isoenzyme Cytochrome P450, family 3, subfamily A (CYP3A)

          -  Known history of human immunodeficiency virus (HIV)

          -  Pregnant or breastfeeding

          -  Unwilling to observe total abstinence or to use double barrier method for birth
             control throughout trial