Enzastaurin Plus Fulvestrant vs. Placebo Plus Fulvestrant in Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: enzastaurin; placebo; fulvestrant
Intervention description: 1125 milligram (mg) loading dose then 250 mg, oral, twice daily (for a total of 500 mg), until disease progression; oral, daily; 500 mg, intramuscular (IM), day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression
Intervention MeSH terms: Fulvestrant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 156.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to help answer the following research question: whether
      enzastaurin given together with fulvestrant can help participants who have breast cancer and
      make the tumor smaller or disappear and for how long.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female participants with a histological-documented diagnosis of locally advanced or
             metastatic breast cancer. The primary or metastatic tumor must be estrogen response
             (ER) and/or parathyroid hormone receptor (PtR) positive.

        Note: Hormone receptor positivity is defined as ER or PtR greater than 10 fmol/mg by
        biochemical assay or 10% positive cells by immunohistochemistry

          -  Participants are resistant to aromatase inhibitors (AI) therapy

          -  Females with postmenopausal status

          -  Previous radiation therapy is allowed, but should have been limited

          -  Measurable or non-measurable disease

          -  Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group
             (ECOG) scale

          -  Have adequate organ function

          -  Have an estimated life expectancy of at least 24 weeks

          -  Must sign an informed consent document

        Exclusion Criteria:

          -  Have had prior treatment with fulvestrant or enzastaurin

          -  Are receiving concurrent administration of any other antitumor therapy, with the
             exception of gonadotropin-releasing hormone (GnRH) antagonists.

          -  Have received treatment within the last 4 weeks with a drug that has not received
             regulatory approval for any indication at the time of study entry

          -  Have received supplemental estrogen or progesterone within 4 weeks prior to study
             entry

          -  Are hormone estrogen receptor (HER2)-positive

          -  Are unable to discontinue use of anticoagulants

          -  Have hypercalcemia

          -  Have a second primary malignancy that is clinically detectable at the time of
             consideration for study enrollment

          -  Have documented central nervous system (CNS) metastases, symptomatic pulmonary
             lymphangitis, or involvement of more than 1/3 of the liver

          -  Have a serious concomitant systemic disorder

          -  Have a serious cardiac condition

          -  Are unwilling or unable to discontinue use of carbamazepine, phenobarbital, or
             phenytoin at least 14 days prior to study therapy

          -  Are unable to swallow tablets.